• Injection: 25 mg/0.5 mL and 50 mg/mL clear, colorless solution in a single-dose prefilled syringe
• Injection: 50 mg/mL clear, colorless solution in a single-dose prefilled SureClick autoinjector
• Injection: 25 mg/0.5 mL clear, colorless solution in a single-dose vial
• For Injection: 25 mg lyophilized powder in a multiple-dose vial for reconstitution
• Injection: 50 mg/mL clear, colorless solution in Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector only

Enbrel is contraindicated in patients with sepsis.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Serious Infections [see Warnings and Precautions (5.1)]
• Neurologic Reactions [see Warnings and Precautions (5.2)]
• Malignancies [see Warnings and Precautions (5.3)]
• Patients with Heart Failure [see Warnings and Precautions (5.4)]
• Hematologic Reactions [see Warnings and Precautions (5.5)]
• Hepatitis B Reactivation [see Warnings and Precautions (5.6)]
• Allergic Reactions [see Warnings and Precautions (5.7)]
• Autoimmunity [see Warnings and Precautions (5.9)]
• Immunosuppression [see Warnings and Precautions (5.10)]

Specific drug interaction studies have not been conducted with Enbrel.

No dose-limiting toxicities have been observed during clinical trials of Enbrel. Single IV doses up to 60 mg/m2 (approximately twice the recommended dose) have been administered to healthy volunteers in an endotoxemia study without evidence of dose-limiting toxicities.

Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.

Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.

Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3.

Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.

1. National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 13 Registries, 1992-2002.
2. Bröms G, Granath F, Ekbom A, et al. Low Risk of Birth Defects for Infants Whose Mothers Are Treated With Anti-Tumor Necrosis Factor Agents During Pregnancy. Clin Gastroenterol Hepatol. 2016;14:234-241.e5

Enbrel (etanercept) injection is supplied as a clear and colorless sterile, preservative-free solution for subcutaneous administration in single-dose prefilled syringes, an Enbrel single-dose prefilled SureClick autoinjector with a 27-gauge, ½-inch needle, or a single-dose vial. The prefilled syringe and SureClick autoinjector are not made with natural rubber latex.

Each Enbrel® Mini single-dose prefilled cartridge for use with the AutoTouch® reusable autoinjector contains 1.0 mL of 50 mg/mL of etanercept. The AutoTouch reusable autoinjector and Enbrel Mini single-dose prefilled cartridge are not made with natural rubber latex.

The AutoTouch reusable autoinjector contains no drug and must use an Enbrel Mini single-dose prefilled cartridge. In addition, the AutoTouch Connect® reusable autoinjector would allow for data connectivity via Bluetooth wireless technology.

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before the patient starts using Enbrel, and each time the prescription is renewed, as there may be new information they need to know.

Patients or their caregivers should be provided the Enbrel "Medication Guide" and provided an opportunity to read it and ask questions prior to initiation of therapy. The healthcare provider should ask the patient questions to determine any risk factors for treatment. Patients developing signs and symptoms of infection should seek medical evaluation immediately.

AMGEN

Enbrel® (etanercept)

Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132

Patent: http://pat.amgen.com/enbrel/

© 1998-2024 Immunex Corporation. All rights reserved.
1XXXXXX – v73

This printed material is recyclable.

This Instructions for Use contains information on how to inject ENBREL with a SureClick autoinjector.

If your healthcare provider decides that you or a caregiver may be able to give your injections of ENBREL at home, you should receive training on the right way to prepare and inject ENBREL. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.

The medicine in the ENBREL autoinjector is for injection under the skin (subcutaneous injection). See the ENBREL Medication Guide for information about ENBREL.

Getting to know your prefilled autoinjector

1. Important Information You Need to Know Before Injecting ENBREL

• It is important that you do not try to give the injection until you have fully read and understood this Instructions for Use.
• Do not use the autoinjector if the carton is damaged or the seal is broken.
• Do not use the autoinjector after the expiration date on the label.
• Do not shake the autoinjector.
• Do not remove the white cap from the autoinjector until you are ready to inject.
• Do not use the autoinjector if it has been frozen.
• Do not use the autoinjector if it has been dropped on a hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use a new autoinjector and call 1-888-4ENBREL (1-888-436-2735).
• Children must weigh at least 138 pounds to use the Enbrel SureClick autoinjector. Children who weigh less than 138 pounds should use a different form of Enbrel.
• The autoinjector is not made with natural rubber latex.

Frequently asked questions:
For additional information and answers to frequently asked questions, visit www.enbrel.com.

Where to get help:
If you want more information or help using ENBREL:

• Contact your healthcare provider,
• Visit www.enbrel.com, or
• Call 1-888-4ENBREL (1-888-436-2735).

2. Storing and Preparing to Inject ENBREL

2a Refrigerate the autoinjector carton until you are ready to use it.

• Keep the autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep the autoinjector in the original carton to protect it from light or physical damage.
• Do not freeze the autoinjector.
• Do not store the autoinjector in extreme heat or cold. For example, avoid storing in your vehicle's glove box or trunk.

WAIT

2b Wait 30 minutes for the autoinjector to reach room temperature.

• Remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator.
• Lift the autoinjector(s) straight up out of the box.
• Let the autoinjector warm up naturally.
• Do not heat the autoinjector with hot water, a microwave, or direct sunlight.
• Do not shake the autoinjector at any time.
• Using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection.

2c You may keep ENBREL at room temperature for up to 30 days, if needed.

• For example, when you are traveling, you may keep ENBREL at room temperature.
  • Keep it at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not put it back in the refrigerator.
  • Record the date you removed it from the refrigerator and use it within 30 days.

2d Inspect the medicine. It should be clear and colorless to slightly yellow.

• It is okay to see air bubbles or small white particles in the autoinjector.
• Do not use ENBREL if the medicine is cloudy, discolored, or contains large lumps, flakes or colored particles.

2e Check the expiration date (Exp.) and inspect the autoinjector for damage.

• Do not use the autoinjector if the expiration date has passed.
• Do not use the autoinjector if:
  • the white cap is missing or loose.
  • it has cracks or broken parts.
  • it has been dropped on a hard surface.
• Make sure you have the right medicine and dose.

3. Getting Ready for Your Injection

3a Gather and place the following items for your injection on a clean, flat, and well-lit surface:

• ENBREL autoinjector (room temperature)
• Sharps disposal container [see Disposing of ENBREL and Checking the Injection Site]
• Alcohol wipe
• Adhesive bandage
• Cotton ball or gauze pad

3b Inject into 1 of these sites.

• Inject into the front of your thigh or stomach (except for 2 inches around your belly button).
• Someone else can inject in your thigh, stomach, or back of the upper arm.
• Choose a different site for each injection.

3c Wash hands thoroughly with soap and water.

3d Clean the injection site with an alcohol wipe.

• Let the skin dry on its own.
• Do not touch this area again before injecting.

4. Injecting ENBREL

4a Grasp the autoinjector so you can see the window. Pull the white cap straight off. You may need to pull hard.

• Do not twist, bend or wiggle the white cap to pull it off.
• Never put the white cap back on. It may damage the needle.
• Do not put your finger inside the dark green safety guard.
• It is normal to see a drop of medicine at the end of the needle or dark green safety guard.

4b Stretch or pinch the skin to create a firm surface at the injection site. Place the dark green safety guard straight against the skin.

• Keep the skin stretched or pinched until the injection is finished.
• Make sure you can see the window.
• Make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle).

PUSH and hold against skin

4c Firmly push the autoinjector down until the dark green safety guard stops moving. Hold the autoinjector down, do not lift.

• The dark green safety guard pushes in and unlocks the purple start button.

PRESS purple start button

4d Keep pushing the autoinjector down and press the purple start button to start the injection.

• You may hear or feel a click.
• The window starts to turn yellow.
• It is okay to let go of the purple start button.

WATCH and CONFIRM that the window turns fully yellow

4e Keep pushing the autoinjector down. When the window is fully yellow, the injection is complete.

• The injection may take up to 15 seconds to complete.
• You may hear or feel a click.
• Lift the autoinjector away from your skin.
• The dark green safety guard locks around the needle.

5. Disposing of ENBREL and Checking the Injection Site

5a Place the used autoinjector and white cap in an FDA-cleared sharps disposal container right away after use.

• Do not reuse the autoinjector.
• Do not touch the dark green safety guard.

5b Check the injection site.

• Do not rub the injection site.
• If there is blood, press a cotton ball or gauze pad on your injection site. Apply an adhesive bandage if necessary.

Additional information about your sharps disposal container

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.

Disposing of sharps disposal containers:

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.

There may be state or local laws about how you should throw away used needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:
http://www.fda.gov/safesharpsdisposal

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

Do not recycle your used sharps disposal container.

Important: Keep the autoinjector and sharps disposal container out of the sight and reach of children. For more information or help call 1-888-4ENBREL (1-888-436-2735).

ENBREL (etanercept)

AMGEN®

Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
©1998 – 2016, 2019-2024 Immunex Corporation. All rights reserved.
nnnnnnnnnn

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 07/2024
V19

How do I prepare and give an injection with Enbrel Single-dose Prefilled Syringe?

There are 2 types of Enbrel single-dose prefilled syringes:

• The 50 mg/mL single-dose prefilled syringe that contains one 50 mg dose of Enbrel.
• The 25 mg/0.5 mL single-dose prefilled syringe that contains one 25 mg dose of Enbrel.

Your healthcare provider will tell you which one to use.

A 50 mg dose can be given as one injection using a 50 mg/mL single-dose prefilled syringe or as two injections using 25 mg/0.5 mL single-dose prefilled syringes. Your healthcare provider will tell you whether the two injections with 25 mg/0.5 mL single-dose prefilled syringes should be given on the same day once a week or on two different days (3 or 4 days apart) in the same week.

Children must weigh at least 138 pounds to use the Enbrel 50 mg/mL single-dose prefilled syringe. Children who weigh less than 138 pounds should use a different form of Enbrel. The Enbrel 25 mg/0.5 mL single-dose prefilled syringe should not be used in pediatric patients weighing less than 68 pounds.

Important: The Enbrel prefilled syringe is not made with natural rubber latex.

Storage of your Enbrel prefilled syringe

• Store the Enbrel prefilled syringe in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Store the Enbrel prefilled syringe in the original carton to protect from light or physical damage.
• If needed, you may store your Enbrel prefilled syringe at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.
  • Once the Enbrel prefilled syringe has reached room temperature, do not put it back in the refrigerator.
• Throw away any Enbrel prefilled syringe that has been stored at room temperature after 30 days.
• Do not store the Enbrel prefilled syringe in extreme heat or cold. For example, avoid storing Enbrel prefilled syringe in your vehicle's glove box or trunk.
• Do not freeze.
• Do not shake.
• Keep the Enbrel prefilled syringe and all medicines out of the reach of children.

If you have any questions about storage, contact your healthcare provider or call 1-888-4ENBREL (1-888-436-2735) for further instructions.

Step 1: Setting Up for an Injection

1. Select a clean, well-lit, flat work surface, such as a table.
2. Take the Enbrel carton containing the prefilled syringes out of the refrigerator and place it on your flat work surface. Remove one prefilled syringe and place it on your work surface. Carefully lift the prefilled syringe straight up out of the box. Do not shake the prefilled syringe of Enbrel. Place the carton containing any remaining prefilled syringes back into the refrigerator at 36°F to 46°F (2°C to 8°C).
3. Check the expiration date on the prefilled syringe. If the expiration date has passed, do not use the prefilled syringe and contact your pharmacist or call 1-888-4ENBREL (1-888-436-2735) for assistance.
4. Do not use the prefilled syringe if the needle cover is missing or not securely attached. Call 1-888-4ENBREL (1-888-436-2735).
5. For a more comfortable injection, leave the prefilled syringe at room temperature for about 15 to 30 minutes before injecting. Do not remove the needle cover while allowing it to reach room temperature. Do not warm Enbrel in any other way (for example, do not warm it in a microwave or in hot water).
6. Hold the prefilled syringe with the covered needle pointing down. If bubbles are seen in the syringe, very gently tap the prefilled syringe to allow any bubbles to rise to the top of the syringe. Turn the syringe so that the purple horizontal lines on the barrel are directly facing you. Check to see if the amount of liquid in the syringe falls between the purple lines. The top of the liquid may be curved. If the syringe does not have the right amount of liquid, do not use that syringe. Contact your pharmacist or call 1-888-4ENBREL (1-888-436-2735) for assistance.

   Fill Level Indicator

7. Assemble the additional supplies you will need for your injection. These include an alcohol swab, a cotton ball or gauze, and a sharps disposal container (see "Step 4: Disposing of Supplies").
8. Wash your hands with soap and warm water.
9. Make sure the solution in the prefilled syringe is clear and colorless. You may notice small white particles in the solution. These particles are formed from Enbrel and this is acceptable. However, do not inject the solution if it is cloudy or discolored, or contains large or colored particles, call 1-888-4ENBREL (1-888-436-2735).

Step 2: Choosing and Preparing an Injection Site

1. Recommended injection sites for Enbrel using a prefilled syringe include:
   • the front of the middle thigh
   • the stomach area (abdomen), except for the 2-inch area right around the navel (belly button)
   • the outer area of the upper arm (only if someone else is giving you the injection)
     
     

     Front                                     Back

2. Rotate the site for each injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.
3. If you have psoriasis, you should not inject directly into any raised, thick, red, or scaly skin patches or lesions.
4. To prepare the area of skin where Enbrel is to be injected, wipe the injection site with an alcohol swab. Do not touch this area again before giving the injection.

Step 3: Injecting Enbrel Using a Prefilled Syringe

Do not remove the needle cover from the prefilled syringe until you are ready to inject.

1. Pick up the prefilled syringe from your flat work surface. Hold the barrel of the prefilled syringe with one hand and pull the needle cover straight off, only when you are ready to inject. Do not leave the needle cover off for more than 5 minutes. This can dry out the medicine.
   To avoid damaging the needle, do not twist or bend the needle cover while you are removing it, and do not try to put the needle cover back onto the prefilled syringe.
   When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal. Do not touch the needle or allow it to touch any surface. Do not touch or bump the plunger. Doing so could cause the liquid to leak out.
2. Holding the syringe with the needle pointing up, check the syringe for air bubbles. If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe.
3. Holding the syringe in one hand like a pencil, use the other hand to gently pinch a fold of skin at the cleaned injection site and hold it firmly.
4. With a quick and "dart-like" motion, insert the needle at a 45-degree angle into the skin.
   
   
5. When the needle is completely inserted into the skin, let go of the skin that you are holding. With your free hand, hold the syringe near its base to stabilize it. Then push the plunger to inject all of the Enbrel solution at a slow, steady rate.
6. When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted. There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a bandage.

Step 4: Disposing of Supplies

The syringe should never be reused. Never recap a needle.

• Put the used prefilled syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) prefilled syringes in your household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
• Do not reuse the syringe.
• Do not recycle the syringe or sharps disposal container or throw them into household trash.

Important: Always keep the sharps disposal container out of the reach of children.

A healthcare provider familiar with Enbrel should answer all questions. Call 1-888-4ENBREL (1-888-436-2735) or visit www.enbrel.com for more information about Enbrel.

This Instructions for Use have been approved by the U.S. Food and Drug Administration.

AMGEN®

Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
© 1998 – 2016, 2019-2020, 2022-2023 Immunex Corporation. All rights reserved.

1XXXXXX – v12
Revised: 06/2023

This printed material is recyclable.

How do I prepare and give an injection with Enbrel multiple-dose vial?

A multiple-dose vial contains 25 mg of Enbrel.

Storage of Enbrel multiple-dose vial

• Store Enbrel multiple-dose vial in the refrigerator at 36°F to 46°F (2°C to 8°C).
  
• Store Enbrel multiple-dose vial in the original carton to protect from light or physical damage.
  
• If needed, you may store your Enbrel multiple-dose vial and diluent syringe (dose tray) at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days.
  ○ Once Enbrel multiple-dose vial has reached room temperature, do not put it back in the refrigerator.
  
• Throw away Enbrel multiple-dose vial that has been stored at room temperature after 14 days.
  
• Mixed (reconstituted) Enbrel multiple-dose vial should be used right away or kept in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 14 days.
  
• Do not store Enbrel multiple-dose vial in extreme heat or cold. For example, avoid storing Enbrel multiple-dose vial in your vehicle’s glove box or trunk.
  
• Do not freeze.
  
• Do not shake.
  
• Keep Enbrel multiple-dose vial and all medicines out of the reach of children.

If you have any questions about storage, contact your healthcare provider or call 1-888-4ENBREL (1-888-436-2735) for further instructions.

Step 1: Setting Up for an Injection

1. Select a clean, well-lit, flat work surface, such as a table.
   
2. Take the Enbrel dose tray out of the refrigerator and place it on your flat work surface.
   
3. Check the expiration date on the dose tray. If the expiration date has passed, do not use the dose tray. Also check to make sure the dose tray has 5 items as pictured below:
   • One prefilled diluent syringe containing 1 mL of diluent (liquid) with attached adapter and twist-off cap
   • One plunger
   • One Enbrel vial
   • One 27-gauge ½ inch needle in hard plastic cover
   • One vial adapter
   

   

   
   If the expiration date has passed, the five items are not included in the dose tray or if any item looks damaged, contact your pharmacist or call 1-888-4ENBREL (1-888-436-2735) for assistance.
   
4. For a more comfortable injection, leave the dose tray at room temperature for about 15 to 30 minutes before injecting.
   
5. Wash your hands with soap and warm water.
   
6. Peel the paper seal off the dose tray and remove all items.
   
7. Inspect the volume of diluent in the syringe with the twist-off cap pointing down. Use the unit markings on the side of the syringe to make sure there is at least 1 mL of liquid in the syringe. If the level of liquid is below the 1 mL mark, do not use. Contact your pharmacist or call 1-888-4ENBREL (1-888-436-2735) for assistance.
   
8. Do not use the syringe if the twist-off cap is missing or not securely attached. Call 1-888-4ENBREL (1-888-436-2735).
   
9. Two alcohol swabs should be available for the preparation and injection of Enbrel. Alcohol swabs can be found at your local drug store.

Step 2: Preparing the Enbrel Solution

There are two methods for preparing the Enbrel solution. For some children, one vial of Enbrel solution can be used for more than one dose. The free-hand method should be used for children on Enbrel who are using one vial of Enbrel solution for more than one dose. You should not use the vial adapter method if you will be using the vial more than once. Ask your healthcare provider if you have questions about which method to use.  

• The Vial Adapter Method

Adults and larger children on Enbrel may use the vial adapter device to assist with mixing the powder with the liquid and withdrawing Enbrel, and then use a 27-gauge needle to inject the dose. This method should not be used for children using multiple doses from the same vial of Enbrel. The instructions for using the vial adapter method are in Step 2A.

• The Free-Hand Method

In the free-hand method, a 25-gauge needle is used to assist with mixing the powder with the liquid and withdrawing Enbrel, and a 27-gauge needle is used to inject the dose. Obtain 25-gauge needles from your healthcare provider. Instructions for using the free-hand method are in Step 2B. 

The instructions for preparing additional doses from the same vial of Enbrel solution are in Step 3. For each additional dose, you will need two new needles (one 25-gauge needle to withdraw the solution and one 27-gauge needle for injection) and one new empty syringe (1 mL). Never reuse a syringe or needle.

If you are using the vial of Enbrel for more than one dose, you should write the date you mixed the powder and liquid in the area marked “Mixing Date:” on the sticker supplied with these instructions, and attach the sticker to the Enbrel vial.

After you have withdrawn the dose of Enbrel that you need, store the Enbrel vial (in the dose tray) in the refrigerator at 36º to 46ºF (2º to 8ºC) as soon as possible, but always within 4 hours of mixing the solution. Do not freeze. If you have any questions about storage, contact your healthcare provider or call 1-888-4ENBREL (1-888-436-2735) for further instructions.

The Enbrel solution must be used within 14 days of the mixing date. You should discard the Enbrel vial and any remaining solution if it is not used within 14 days. Do not mix any remaining liquid in one vial of Enbrel solution with another.

STEP 2A: Vial Adapter Method

1. Remove the pink plastic cap from the Enbrel vial. Do not remove the gray stopper or silver metal ring around the top of the Enbrel vial.
   

   

   
   
2. Place the Enbrel vial on your flat work surface or turn your dose tray upside down and place your Enbrel vial in the round space marked “V”. Use one alcohol swab to clean the gray stopper on the Enbrel vial. Do not touch the gray stopper with your hands.
   
3. Open the wrapper that contains the 27-gauge needle by peeling apart the tabs and set the needle aside for later use.
   

   

   
   
4. Open the wrapper that contains the vial adapter by peeling apart the tabs and set the vial adapter aside for later use. Do not touch the vial adapter’s twist-on end or the spike inside.
   

   

   
   
5. Slide the plunger into the flange end of the syringe.
   

   

   
   
6. Attach the plunger to the gray rubber stopper in the syringe by turning the plunger clockwise until you feel a slight resistance.
   

   

   
   
7. Remove the twist-off cap from the prefilled diluent syringe by turning counter-clockwise. Do not bump or touch the plunger. Doing so could cause the liquid to leak out. You may see a drop of liquid when removing the cap. This is normal. Place the cap on your flat work surface. Do not touch the syringe tip.
   

   

   
   
8. Once the twist-off cap is removed, pick up the vial adapter with your free-hand. Twist the vial adapter onto the syringe, turning clockwise until you feel a slight resistance. Do not over-tighten.
   

   

   
   
9. Hold the Enbrel vial upright on your flat work surface. Grasp the sides of the vial adapter and place it over the top of the Enbrel vial. Do not bump or touch the plunger. Doing so could cause the liquid to leak out. Insert the vial adapter into the gray stopper on the Enbrel vial. The plastic spike inside the vial adapter should puncture the gray stopper. The vial adapter should fit snugly.
   

   

   
   
10. Hold the Enbrel vial upright on your flat work surface and push the plunger down until all the liquid from the syringe is in the Enbrel vial. You may see foaming (bubbles) in the vial. This is normal.
    

    

    
    
11. Gently swirl the Enbrel vial in a circular motion to dissolve the powder. If you used the dose tray to hold your Enbrel vial, take the vial (with the vial adapter and syringe still attached) out of the dose tray, and gently swirl the vial in a circular motion to dissolve the powder.
    

    

    
    Do not shake. Wait until all the powder dissolves (usually less than 10 minutes). The solution should be clear and colorless. After the powder has completely dissolved, foam (bubbles) may still be present. This is normal. Do not inject the solution if it is discolored, contains lumps, flakes, or particles. If all the powder in the Enbrel vial is not dissolved or there are particles present after 10 minutes, call 1-888-4ENBREL (1-888-436-2735).
    
12. Turn the Enbrel vial upside down. Hold the syringe at eye level and slowly pull the plunger down to the unit markings on the side of the syringe that correspond with your/your child’s dose. For adult patients, remove the entire volume (1 mL), unless otherwise instructed by your healthcare provider. Be careful not to pull the plunger completely out of the syringe. Some white foam may remain in the Enbrel vial. This is normal.
    

    

    
    
13. Check for air bubbles in the syringe. Gently tap the syringe to make any air bubbles rise to the top of the syringe. Slowly push the plunger up to remove the air bubbles. If you push solution back into the vial, slowly pull back on the plunger to again draw the correct amount of solution back into the syringe.
    

    

    
    
14. Remove the syringe from the vial adapter, by holding the vial adapter with one hand and turning the syringe counter-clockwise with your other hand. Do not touch or bump the plunger. Place the Enbrel vial with the vial adapter on your flat work surface.
    

    

    
    
15. Continue to hold the barrel of the syringe. With your free-hand, twist the 27-gauge needle onto the tip of the syringe until it fits snugly. Do not remove the needle cover from the syringe. Place the syringe on your flat work surface until you are ready to inject Enbrel.
    

    

Go to Step 4: Choosing and Preparing an Injection Site.

Step 2B: Free-Hand Method

If you are preparing a dose from an Enbrel vial that was previously used, go to Step 3: Preparing Additional Doses from a Single Enbrel Vial.

1. Remove the pink plastic cap from the Enbrel vial. Do not remove the gray stopper or silver metal ring around the top of the Enbrel vial. Write the date you mix the powder and solution on the supplied “Mixing Date:” sticker and attach it to the Enbrel vial.
   

   

   
   
2. Place the Enbrel vial on your flat work surface. Use one alcohol swab to clean the gray stopper on the Enbrel vial. Do not touch the gray stopper with your hands.
   
3. Open the wrapper that contains the 25-gauge needle by peeling apart the tabs and set the needle aside for later use. The 25-gauge needle will be used to mix the liquid with the powder and for withdrawing Enbrel from the vial.
   

   

   
   
4. Slide the plunger into the flange end of the syringe.
   

   

   
   
5. Attach the plunger to the gray rubber stopper in the syringe by turning the plunger clockwise until you feel a slight resistance.
   

   

   
   
6. Remove the twist-off cap from the prefilled diluent syringe by turning counter-clockwise. Do not touch or bump the plunger. Doing so could cause the liquid to leak out. You may see a drop of liquid when removing the cap. This is normal. Place the cap on your flat work surface. Do not touch the syringe tip.
   

   

   
   
7. Continue to hold the barrel of the syringe. With your free-hand, twist the 25-gauge needle onto the tip of the syringe until it fits snugly. Place the syringe on your flat work surface.
   

   

   
   
8. Open the wrapper that contains the 27-gauge needle by peeling apart the tabs and set the needle aside for later use.  The 27-gauge needle will be used to inject the dose.
   

   

   
   
9. Pick up the syringe from your flat work surface. Hold the barrel of the syringe with one hand, and pull the needle cover straight off. To avoid damaging the needle, do not twist or bend the needle cover while you are removing it. Do not touch the needle or allow it to touch any surface. Do not touch or bump the plunger. Doing so could cause the liquid to leak out.
   

   

   
   
10. Place the needle cover (open side up) in the round space marked “N” in the Enbrel dose tray.
    

     
    

11. Place the Enbrel vial on your flat work surface. Hold the syringe with the needle facing up, and gently pull back on the plunger to pull a small amount of air into the syringe. Then, insert the needle straight down through the center ring of the gray stopper (see illustrations). You should feel a slight resistance and then a “pop” as the needle goes through the center of the stopper. Look for the needle tip inside the open stopper window. If the needle is not correctly lined up with the center of the stopper, you will feel constant resistance as it goes through the stopper and no “pop”. The needle may enter at an angle and bend, break or prevent you from adding diluent into the Enbrel vial.

    

12. Push the plunger down very slowly until all liquid from the syringe is in the Enbrel vial. Adding the liquid too fast will cause foaming (bubbles).

    

13. Leave the syringe in place. Gently swirl the Enbrel vial in a circular motion to dissolve the powder.

    

    Do not shake. Wait until all the powder dissolves (usually less than 10 minutes). The solution should be clear and colorless. After the powder has completely dissolved, foam (bubbles) may still be present. This is normal. Do not inject the solution if it is discolored, contains lumps, flakes, or particles. If all the powder in the Enbrel vial is not dissolved or there are particles present after 10 minutes, call 1-888-4ENBREL (1-888-436-2735).
    
14. With the needle in the Enbrel vial, turn the vial upside down. Hold the syringe at eye level and slowly pull the plunger down to the unit markings on the side of the syringe that correspond with the correct dose. Make sure to keep the tip of the needle in the solution. Some white foam may remain in the Enbrel vial. This is normal.
    

    

    
    
15. With the needle still inserted in the Enbrel vial, check for air bubbles in the syringe. Gently tap the syringe to make any air bubbles rise to the top of the syringe. Slowly push the plunger up to remove the air bubbles. If you push solution back into the vial, slowly pull back on the plunger to draw the correct amount of solution back into the syringe.
    

    

    
    
16. Remove the syringe and needle from the Enbrel vial. Keep the needle attached to the syringe and insert the 25-gauge needle straight down into the needle cover in the Enbrel dose tray.
    

    

    
    You should hear a “snap” when the needle is secure in the needle cover. Once the needle is secure in the needle cover, untwist the 25-gauge needle from the syringe and dispose of the needle in your sharps disposal container (see “Step 6: Disposing of Supplies”).
    
17. Twist the 27-gauge needle onto the syringe until it fits snugly. Do not remove the needle cover from the syringe. Place the syringe on your flat work surface until you are ready to inject Enbrel.
    

    

    
    
18. If there is enough solution left in the Enbrel vial for another dose, write the date you mixed the powder and liquid in the area marked “Mixing Date:” on the sticker supplied with these instructions, and attach the sticker to the Enbrel vial. Refrigerate the reconstituted (mixed) Enbrel vial (in the dose tray) after mixing. Prepare additional doses from the Enbrel vial as described in Step 3. Otherwise, throw away (discard) the Enbrel vial and any remaining solution.

Go to Step 4: Choosing and Preparing an Injection Site. 

Step 3: Preparing Additional Doses from a Single Enbrel Vial

1. Select a clean, well-lit, flat work surface, such as a table.
   
2. Do not reuse the needles and syringes supplied with Enbrel dose tray. You will need new needles and syringes for each additional dose. Your healthcare provider will tell you what type of syringes (1 mL) and needles (25-gauge and 27-gauge) to use. Place the sterile syringe with a 25-gauge needle (for withdrawing Enbrel), a 27-gauge needle (for injecting Enbrel) and two alcohol swabs on your flat work surface.
   
3. Take the vial of Enbrel solution that is stored in the dose tray out of the refrigerator and place it on your flat work surface.
   
4. Check the mixing date you wrote on the sticker on the Enbrel vial. Discard the Enbrel vial if more than 14 days have passed since the Enbrel solution was mixed.
   
5. Wash your hands with soap and warm water.
   
6. Use one alcohol swab to clean the gray stopper on the Enbrel vial. Do not touch the stopper with your hands.
   
7. If the syringe and the 25-gauge needle are not pre-assembled, assemble them as instructed by your healthcare provider.
   
8. Open the wrapper that contains the 27-gauge needle by peeling apart the tabs and set the needle aside for later use. The 27-gauge needle will be used to inject the dose of Enbrel.
   
9. Hold the syringe and pull the needle cover straight off. To avoid damaging the needle, do not twist or bend the needle cover while you are removing it. Do not touch the needle or allow it to touch any surface. Place the needle cover (open side up) in the round space marked “N” in the Enbrel dose tray.
   
10. Place the Enbrel vial on your flat work surface. Hold the syringe with the needle facing up, and gently pull back the plunger to pull a small amount of air into the syringe. Then, insert the 25-gauge needle straight down through the center ring of the gray stopper. You should feel a slight resistance and then a “pop” as the needle goes through the center of the stopper. Look for the needle tip inside the open stopper window. If the needle is not correctly lined up with the center of the stopper, you will feel constant resistance as it goes through the stopper and no “pop”. The needle may enter at an angle and bend, break, or prevent proper withdrawal of Enbrel solution from the vial.
    
11. Keep the needle in the Enbrel vial and turn the vial upside down. Hold the syringe at eye level, and slowly pull the plunger down to the unit markings on the syringe that correspond to your child’s dose. As the amount of solution in the Enbrel vial drops, you may need to pull the needle back just enough to keep the tip of the needle in the solution.
    
12. With the needle still inserted in the Enbrel vial, check for air bubbles in the syringe. Gently tap the syringe to make any air bubbles rise to the top of the syringe. Slowly push the plunger up to remove the air bubbles. If you push solution back into the Enbrel vial, slowly pull back on the plunger to again draw the correct amount of solution back into the syringe.
    
13. Remove the syringe and needle from the Enbrel vial. Keep the needle attached to the syringe and insert the 25-gauge needle straight down into the needle cover in the Enbrel dose tray. You should hear a “snap” when the needle is secure in the needle cover. Once the needle is secure in the needle cover, remove the 25-gauge needle from the syringe and dispose of the needle in a sharps disposal container (see “Step 6: Disposing of Supplies”).
    
14. Attach the 27-gauge needle onto the tip of the syringe until it fits snugly. Do not remove the needle cover from the syringe. Place the syringe on your flat work surface until you are ready to inject Enbrel. 

Step 4: Choosing and Preparing an Injection Site

1. The 3 recommended injection sites for Enbrel include:
   • the front of the middle thighs
   • the stomach area (abdomen), except for the 2-inch area right around the navel (belly button)
   • the outer area of the upper arms (only if someone else is giving you the injection)
   
2. Rotate the site for each injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.
   
3. If you have psoriasis, you should not inject directly into any raised, thick, red, or scaly skin patches or lesions.
   
4. To prepare the area of skin where Enbrel is to be injected, wipe the injection site with a new alcohol swab. Do not touch this area again before giving the injection.

Step 5: Injecting the Enbrel Solution

Do not remove the needle cover from the syringe until you are ready to inject.

1. Pick up the syringe from your flat work surface. Hold the barrel of the syringe with one hand and pull the needle cover straight off. To avoid damaging the needle, do not twist or bend the needle cover while you are removing it, and do not try to put the needle cover back onto the syringe. When you remove the needle cover, there may be a drop of liquid at the end of the needle. This is normal.  Do not touch the needle or allow it to touch any surface. Do not touch or bump the plunger. Doing so could cause the liquid to leak out.
   

   

   
   
2. With one hand, gently pinch the cleaned area of skin and hold it firmly. With the other hand, hold the syringe (like a pencil) at a 45-degree angle to the skin.

   

3. With a quick and "dart-like" motion, insert the needle at a 45-degree angle into the skin.
   
4. When the needle is completely inserted into the skin, let go of the skin that you are holding. With your free-hand, hold the syringe near its base to stabilize it. Then push the plunger to inject all of the Enbrel solution at a slow, steady rate.
   

   

   
   
5. When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
   
6. There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a bandage.
   
7. If your healthcare provider has instructed you to take two Enbrel injections on the same day, repeat the steps to prepare and give an injection of Enbrel. Choose and prepare a new injection site for the second injection.
   
8. For the Free-Hand Method: If there is enough solution left in the Enbrel vial for another dose, refrigerate the reconstituted (mixed) Enbrel vial (in the dose tray) after use. Otherwise, discard the Enbrel vial and any remaining solution.

Step 6: Disposing of Supplies

The syringe, needles, and vial adapter should never be reused. Never recap a needle.

• Put the used syringes, needles, and vials in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles, syringes, and vials in your household trash.
  
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  ○ made of a heavy-duty plastic,
  ○ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  ○ upright and stable during use,
  ○ leak-resistant, and
  ○ properly labeled to warn of hazardous waste inside the container.
  
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal
  
• Do not reuse the syringe or vial.
  
• Do not recycle the syringe, vial, or sharps disposal container or throw them into household trash.

Important: Always keep the sharps disposal container out of the reach of children.

A healthcare provider familiar with Enbrel should answer all questions. Call 1-888-4ENBREL (1-888-436-2735) or visit www.enbrel.com for more information about Enbrel.

This Instructions for Use have been approved by the U.S. Food and Drug Administration.

AMGEN®

Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132

© 1998 – 2016, 2019 Immunex Corporation. All rights reserved.

1XXXXXX – v9

Revised: 10/2019

 This printed material is recyclable.

Front Panel Text

Read these instructions before using an AutoTouch® reusable autoinjector for use with Enbrel Mini® (etanercept) single-dose prefilled cartridge.

Side 1 Text

Your healthcare provider has prescribed Enbrel® AutoTouch reusable autoinjector for your injections. If your healthcare provider decides that you or a caregiver may be able to give your injections of Enbrel at home, you should receive training on the right way to prepare and inject Enbrel. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider. Call your healthcare provider if you or your caregiver has any questions about the right way to inject Enbrel.

Read these instructions before using an AutoTouch reusable autoinjector for use with Enbrel Mini (etanercept) single-dose prefilled cartridge.

Speed switch Changing injection speed The AutoTouch reusable autoinjector allows you to choose the speed of your injection. You can try the three speeds to decide which speed is most comfortable for you. Three speed settings are available: Fast, Medium, and Slow. The factory setting is set to Medium, the black dot (•). To change the injection speed: For a faster injection, move the speed switch up to the plus sign (+). For a slower injection, move the speed switch down to the minus sign (-). NOTE: When you receive your AutoTouch reusable autoinjector, the speed will be set to Medium (•). Set the injection speed before you place the autoinjector on your skin and press the start button. The injection speed cannot be changed after you begin an injection.

Sound switch Turning sounds off The AutoTouch autoinjector makes sounds () to help guide your injection. When you receive a new autoinjector, it will be set with the sounds on (sound switch down). To turn off these sounds, slide the sound switch up (red bar is visible). Even when the sound is turned off, you will still hear the noise of the motor during the injection and will hear any error alerts to warn you there is a problem. See (Troubleshooting: Error symbols) below if you receive any error alerts.

Side 2 Text

INSTRUCTIONS FOR USE
ENBREL® (en-brel)
(etanercept)
injection, for subcutaneous use
Enbrel Mini® Single-dose Prefilled Cartridge
for use with all AutoTouch® Reusable Autoinjectors

Guide to parts
AutoTouch reusable autoinjector

Important: The needle is inside Enbrel Mini.

Important

The AutoTouch® reusable autoinjector is used with the Enbrel Mini® single-dose prefilled cartridge to administer your dose of Enbrel®. The Enbrel Mini single-dose prefilled cartridge contains one 50 mg single-dose of Enbrel.

Before you use the AutoTouch reusable autoinjector with Enbrel Mini single-dose prefilled cartridge for use with Enbrel, read this important information:

Storing your Enbrel Mini single-dose cartridges:

• Store Enbrel Mini, which contains Enbrel, in the refrigerator between 36°F to 46°F (2°C to 8°C).
• If needed, you may store Enbrel Mini at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.
  • Once Enbrel has reached room temperature, do not put it back in the refrigerator.
• Throw away (dispose of) Enbrel Mini that has been stored at room temperature after 30 days.
• Do not store Enbrel Mini in extreme heat or cold. For example, avoid storing in your vehicle's glove box or trunk.
• Do not freeze.
• Do not shake.
• Store Enbrel Mini in the original carton to protect from light or damage.

Using your Enbrel Mini single-dose cartridges:

• It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.
• Do not use Enbrel Mini after the expiration date printed on the label.
• Do not shake Enbrel Mini.
• Do not remove the purple cap from Enbrel Mini until it is inside the AutoTouch reusable autoinjector and you are ready to inject.
• Do not use Enbrel Mini if it has been dropped on a hard surface. Part of Enbrel Mini may be broken even if you cannot see the break. Use a new Enbrel Mini cartridge, and call 1-888-4Enbrel (1-888-436-2735).
• The AutoTouch reusable autoinjector and the Enbrel Mini cartridge are not made with natural rubber latex.
• Children must weigh at least 138 pounds to receive 50 mg Enbrel Mini. Children who weigh less than 138 pounds should receive a different form of Enbrel.

Storing your AutoTouch reusable autoinjector:

• Store AutoTouch at room temperature in a dry, safe place, such as a cabinet or drawer at 50°F to 104°F (10°C to 40°C).
• Use an alcohol wipe to clean the bottom (injection end) before and after each use.
• Do not store AutoTouch in the refrigerator with Enbrel Mini.

Keep Enbrel Mini and AutoTouch and all medicines out of the reach of children.

For more information or help, visit www.enbrel.com or call 1-888-4Enbrel (1-888-436-2735). Read your AutoTouch User Manual for additional care and storage information.

Step 1: Prepare

A Remove one Enbrel Mini® single-dose cartridge from the carton.

• Put the carton containing any unused Enbrel Mini back in the refrigerator.
• Leave Enbrel Mini at room temperature for at least 30 minutes before injecting.
• Do not put Enbrel Mini back in the refrigerator once it has reached room temperature.
• Do not try to warm Enbrel Mini by using a heat source such as hot water or microwave.
• Do not shake Enbrel Mini.
• Do not remove the purple cap from Enbrel Mini yet.

B Inspect the Enbrel Mini single-dose prefilled cartridge.

Make sure the medicine in the window is clear and colorless. It is okay if you see small white particles in the medicine window.

• Do not use Enbrel Mini if the medicine is cloudy, discolored, or contains large lumps, flakes, or colored particles.
• Do not use Enbrel Mini if any part appears cracked or broken.
• Do not use Enbrel Mini if the purple cap is missing or not securely attached.
• Do not use Enbrel Mini if the expiration date printed on the label has passed.

In all cases, use a new Enbrel Mini, and call 1-888-4Enbrel (1-888-436-2735).

C Gather all materials you need for your injection.

Wash your hands thoroughly with soap and water.

Place the following on a clean, well-lit, flat surface:

• AutoTouch®
• 1 Enbrel Mini®
• 3 alcohol wipes
• Cotton ball or gauze pad
• Adhesive bandage
• Sharps disposal container

D Prepare and clean your injection site.

Also clean the injection end of the AutoTouch® with a new alcohol wipe.

Clean your injection site with an alcohol wipe. Let your skin dry.

You can use:

• Your thigh
• Stomach area (abdomen), except for a 2-inch area right around your navel
• Outer area of upper arm (only if someone else is giving you the injection)

Important:

• Do not touch this area again before injecting.
• Choose a different site each time you give yourself an injection. If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
• Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
• If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patches or lesions.

Step 2: Get ready

E Press the door button to open the door.

F Hold the Enbrel Mini® single-dose cartridge with the labeled side facing out and slide into door.

Hold with the labeled side facing out and the purple cap pointing down. Then slide Enbrel Mini into the door. It will slide all the way down into AutoTouch®.

• Do not force Enbrel Mini into AutoTouch if it does not slide in easily. Check that it is positioned correctly inside AutoTouch.

G Close the door.

When you see the viewing window light up and hear a "chime", this means that Enbrel Mini® has been loaded properly. AutoTouch is now in the awake mode. Note: If the sound switch is set to the "sounds off" position, you will not hear this sound. To turn the "sounds on", slide the sound switch down. The red bar will no longer be visible.

Sounds onSlide switch down

Sounds off Slide switch up

Important: Do not remove the purple cap until you are ready to give your injection.

Step 3: Inject

Read the following information before proceeding with your injection.

You will now be performing the following tasks in order:

• Hold AutoTouch® correctly.
• Remove the purple cap.
• Confirm that AutoTouch is "awake".
• Place and hold AutoTouch on the injection site.
• After the status button turns green, press the status button to start the injection.
• Wait for the injection to finish (ensure that AutoTouch maintains full contact with the skin).
• Confirm the injection is complete.

Do not give your injection until you have read these instructions and feel comfortable with how to use AutoTouch the right way.

H Hold the AutoTouch reusable autoinjector with fingers wrapped around the gray finger grip as shown. Before placing AutoTouch on your skin, make sure that AutoTouch is "awake". Look to see that the viewing window light is on. If the viewing light is off this means it is in "sleep mode", press the status button to "wake it up".

I When you are ready to inject, pull the purple cap straight down and off. Do not leave the purple cap off for more than 5 minutes. This can dry out the medicine.

Dispose of the purple cap in a sharps disposal container. Small parts such as the purple cap may cause a choking hazard for children and pets. The AutoTouch® site light will turn on to help you see the injection site. It is normal to see a drop of liquid at the end of Enbrel Mini® needle or bottom of AutoTouch. Do not twist or bend the purple cap. Do not put the purple cap back onto AutoTouch. Do not remove the purple cap from AutoTouch until you are ready to inject. If you are unable to inject, please contact your healthcare provider.

J Place and hold on the skin. Wait for the status button to turn green and a chime to sound.

Gently place and hold the AutoTouch® reusable autoinjector on your skin and wait 2 seconds for the status button to turn green. You will hear a "chime" (unless the sound switch is set to the "sounds off" position).

• Keep your thumb off the status button during this step.
• Do not press the autoinjector hard on your skin. There is no need to stretch or pinch your skin.

K Press and release the status button. The status button will start to flash green. You will hear a click when the injection starts.

The green status button means your injection has started. You will hear a motor noise and the status button will flash green.

Important: Do not lift AutoTouch® off your skin while the injection is in progress. Continue to hold AutoTouch straight and steady.

L The injection is finished when the green light turns off and a "chime" sounds. Check to make sure you do not see a red status button.

	(light off) Injection finished	(red light on) Injection error Call 1-888-4Enbrel (1-888-436-2735)

Lift AutoTouch® off your skin.

When your injection is finished, you will hear a motor noise for a few seconds. When finished, the door will automatically open. Do not block the door with your hand.

Important: When you remove AutoTouch, if the status button has turned red, call 1-888-4Enbrel (1-888-436-2735). If it looks like the medicine is still injecting or if you see medicine in the Enbrel Mini® window, this means you may not have received a full dose. Call your healthcare provider right away.

Step 4: Finish

M Remove and throw away (dispose of) the Enbrel Mini® single-dose prefilled cartridge.

When the door opens, remove Enbrel Mini, close the door, then put it in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) Enbrel Mini in your household trash.

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• upright and stable during use
• leak-resistant, and properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

• Do not reuse Enbrel Mini.
• Do not recycle Enbrel Mini or the sharps disposal container or throw them into household trash.

Important: Always keep the sharps disposal container out of the reach of children.

N Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage, if needed.

O Clean and store the AutoTouch® reusable autoinjector.

Clean the injection end of the autoinjector with a new alcohol wipe and allow to dry.

Store AutoTouch at room temperature in a dry, safe place such as in a cabinet or drawer.

Important: Do not store AutoTouch in the refrigerator.

Troubleshooting: Error symbols

Why is the status button flashing red?
	Low battery: The battery is very low. Only a few injections remain. Note: battery icon may be yellow on some devices. Call 1-888-4Enbrel (1-888-436-2735) for a replacement AutoTouch reusable autoinjector.
	Battery dead: The battery is dead. Note: battery icon may be yellow on some devices. Call 1-888-4Enbrel (1-888-436-2735) for a replacement AutoTouch reusable autoinjector.
	Too hot or too cold: AutoTouch reusable autoinjector is too hot, or too cold. Allow to naturally cool or warm to room temperature until symbols are gone.
	Enbrel Mini® problem: There are several reasons you might get this error. See the User Manual for more information or call 1-888-4Enbrel (1-888-436-2735).
	Needle exposure: The needle may be exposed and an incomplete dose may have been injected. Look for medicine in Enbrel Mini. Call your healthcare provider if you feel you have given yourself an incomplete injection. Take special care when removing and handling Enbrel Mini by disposing properly in the sharps container.
	AutoTouch reusable autoinjector failure: Call 1-888-4Enbrel (1-888-436-2735) for reset instructions or a replacement AutoTouch reusable autoinjector.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

AMGEN®

Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
©1998 – 2018, 2021-2023 Immunex Corporation. All rights reserved.
[partnumber]
Revised: 06/2023 v7
U.S. License Number 1132

This printed material is recyclable.

AutoTouch® reusable
autoinjector for use with
Enbrel Mini® (etanercept)
single-dose prefilled cartridge

User Manual

This User Manual contains helpful information about your AutoTouch® reusable autoinjector. It includes resources, care details, and a troubleshooting guide to save for ongoing reference.

To learn how to inject using AutoTouch, see your healthcare provider for injection training and use the Instructions for Use included in the carton.

Instructions for Use

A fold-out, step-by-step Instructions for Use is provided in the carton, which provides you with full instructions to learn how to give yourself a safe, successful and accurate injection.

Note: Please read the full Instructions for Use included in the carton.

The Reference Guide on the next page should only be used when you have successfully completed an injection using the Instructions for Use.

Personalized help from ENBREL Support™

Here are just a few of the benefits available at no cost to you:

• Live nurses online or on the phone seven days a week, 8 AM to 11 PM (ET)
  
• ENBREL Support copay card and other financial help
  
• Medication and refill reminders by phone or email
  
• Needle disposal containers through the Sharps Mail-Back Program

Sign up at 1-888-4ENBREL (1-888-436-2735) or EnbrelSupport.com.

AutoTouch® reusable autoinjector

Door button

Press this button to open the door for insertion of the Enbrel Mini® single-dose prefilled cartridge. When your injection is finished, the door will open automatically.

Viewing window

During an injection, you can look through this window and see the plunger lowering to deliver your medicine. When AutoTouch is awake, the viewing window will light up. If Enbrel Mini is in AutoTouch, and the viewing window has no light, then press the status button to wake up AutoTouch.

You will open this door and insert Enbrel Mini into AutoTouch. The door will open automatically when your injection is finished. When inserted properly, Enbrel Mini will slide freely and completely into and out of the door.

AutoTouch® reusable autoinjector

Status button

Press this button to begin an injection. Lights will indicate the status of your injection.

Green:
Ready to press and start injection.

Blinking green:
The needle is inserting and your injection is in progress.

Red:
An error has occurred. See the Troubleshooting section of this manual.

Progress bar

These stacked green bars are fully lit when your injection starts, and the bar of lights decrease as your injection is in progress. The lights will disappear when your injection is finished.

Speed switch

The AutoTouch® reusable autoinjector allows you to choose from three injection speeds. The pre-set speed is medium.
(+) is faster
(•) is medium
(–) is slower

AutoTouch® reusable autoinjector

Sound switch

Sounds can be turned off and on. (Sounds on) Slide switch down. (Sounds off) Slide switch up so that the red bar is visible.

Note: Error sounds will still be heard if the sounds have been turned off.

Injection end

The entire injection end must be touching your skin during injections. This is also where the needle will come out.

Skin sensor

A skin sensor is located on the injection end. When the injection end is placed on skin the start button light will turn green. Hold the injection end flat and steady on your skin throughout the entire injection process.

Site light

When the Enbrel Mini® single-dose prefilled cartridge is loaded and the purple cap is removed, the injection end will light up to help you see your injection site.

Enbrel Mini® single-dose prefilled cartridge

Labeled side

When inserting the Enbrel Mini® cartridge make certain that the labeled side is facing out. Then slide Enbrel Mini into the door. It will slide all the way down into the AutoTouch® reusable autoinjector.

Expiration date

Confirm expiration date printed on the label has not passed.

Enbrel Mini window

This is where you will look to examine your medicine before starting an injection. See Instructions for Use for more information.

Purple cap

The purple cap keeps your medicine safe. Do not remove the cap on Enbrel Mini before loading it into AutoTouch. Load Enbrel Mini with the purple cap on, and remove the cap only when you are ready to give yourself the injection. Do not leave the purple cap off for more than five minutes. This can dry out the medicine.

See the Instructions for Use for more detail about loading Enbrel Mini and when to remove the purple cap.

AutoTouch® reusable autoinjector

How it works.

When you push the status button to start an injection, the AutoTouch® reusable autoinjector pushes a hidden needle out of the Enbrel Mini® single-dose prefilled cartridge into your skin. Then, a plunger rod will push into Enbrel Mini, injecting medicine into your body. After the medicine is injected, the rod will pull back up and the needle will withdraw from your skin. After a successful injection all lights will turn off and the door will open. The needle stays hidden at all times during the injection process.

What you will hear.

Needle insertion and plunger rod are operated by motors. You will hear a motor noise as the rod moves down and then back up again. Whenever you hear a motorized noise, you will know that an injection is in progress.

What you will see.

During the injection, the viewing window light will be on, and the plunger rod will move through the window. Also during the injection, the status light will be flashing green, and the progress bar will decrease. After a successful injection, the progress bar, and status button will turn off, and AutoTouch will open the door.

If the status light turns red, and beeps for more than a few seconds, an error has occurred. Use the troubleshooting section of this manual to see what to do if this happens.

Error Symbols

The AutoTouch® reusable autoinjector makes a chime sound, lights the status button red, and displays an error symbol if there is a problem.

See the following description of each error symbol, possible reasons for the error, and actions you can take.

Low battery

Symbol: Orange battery and error sound.
Problem: The battery is running very low. Less than three weeks or three injections remain. The battery has a life of two years or 130 injections from your first injection. The battery is not replaceable or rechargeable.
Action: Call 1-888-4ENBREL (1-888-436-2735) for a replacement AutoTouch reusable autoinjector.

Battery Dead

Symbol: Orange battery and red triangle with exclamation point, red status button, and error sound.
Problem: The AutoTouch® reusable autoinjector battery is dead.
Action: Call the 1-888-4ENBREL (1-888-436-2735) for a replacement AutoTouch reusable autoinjector.

Too hot or cold

Symbol: Orange sun and a snowflake, and an error sound.
Problem: AutoTouch is too hot or too cold. This will lock the door.
Action: Place AutoTouch at room temperature in a safe, dry place and allow it to naturally cool or warm to room temperature. Then try again. Store the AutoTouch reusable autoinjector in a dry, safe place, such as a cabinet or drawer at 50° F to 104° F (10° C to 40° C).

Troubleshooting: Error Symbols

Enbrel Mini problem

Symbol: Orange Enbrel Mini® single-dose prefilled cartridge with blinking red status button and error alert sound.
Problem: There are five possible reasons you are getting this error. Please read below.

Problem #1: The purple cap was removed before inserting Enbrel Mini.
Action: Wait for the error to clear and close the door without Enbrel Mini in, and try again with a new Enbrel Mini. Make sure to leave the purple cap on until Enbrel Mini has been placed inside the AutoTouch® reusable autoinjector and the door is closed. Call 1-888-4ENBREL (1-888-436-2735) for a replacement Enbrel Mini.

Problem #2: Sensor lost skin contact during injection.
Action: Hold the injection end of AutoTouch on your skin throughout the entire injection until the green status button turns off, even if the motor sounds stop. Lifting or shifting on your skin during injection may lead to an incomplete injection. Call your healthcare provider if you feel you have given yourself an incomplete injection.

Problem #3: Enbrel Mini® single-dose prefilled cartridge is defective or not recognized as an Amgen product.
Action: Remove Enbrel Mini. Replace with a new Enbrel Mini. Call 1-888-4ENBREL (1-888-436-2735) for a replacement Enbrel Mini.

Problem #4: Door is held closed for more than one minute.
Action: Remove your hand from the door. When the door opens, remove Enbrel Mini from AutoTouch®, if present. Wait for the error symbol to stop blinking and close the door. If you have not given yourself an injection, place a new Enbrel Mini in AutoTouch and continue. If the error symbol remains on, call 1-888-4ENBREL (1-888-436-2735).

Problem #5: AutoTouch has been dropped.
Action: A dropped AutoTouch is not safe to use. Call 1-888-4ENBREL (1-888-436-2735) for a replacement.

Troubleshooting: Error Symbols

Needle Exposure

Symbol: Orange Enbrel Mini® single-dose prefilled cartridge, a red triangle with an exclamation point, red status button, and error sound.
Problem: A problem occurred during an injection and the needle may be exposed.
Action: If there is still fluid in Enbrel Mini, an incomplete dose may have been injected. Call your healthcare provider if you feel you have given yourself an incomplete injection. Call 1-888-4ENBREL (1-888-436-2735) for further assistance with your AutoTouch®.

Use caution when both Enbrel Mini problem symbol and the AutoTouch® reusable autoinjector failure symbols are lit as the needle may be exposed. Take special care when removing and handling Enbrel Mini. Remove Enbrel Mini then put it in a FDA-cleared sharps disposal container.

AutoTouch® Reusable Autoinjector Failure

Symbol: Red triangle with an exclamation point, red status button, and error sound.
Problem: Several errors have occurred or AutoTouch has stopped working.
Action: Reset AutoTouch.

To reset AutoTouch:

Hold AutoTouch away from skin and press the status button to wake AutoTouch. The failure symbol should begin blinking and a chime should sound.

While the failure symbol is blinking, press and hold door button until all symbols are temporarily displayed and the status button blinks green. The door button should be held for at least 10 seconds. After a successful reset, if an Enbrel Mini® single-dose prefilled cartridge is still inside AutoTouch, remove it. Close the AutoTouch door. Then, for the next injection, start by pressing the door button to open Enbrel Mini door.

If AutoTouch does not respond after three attempts to reset, call 1-888-4ENBREL (1-888-436-2735).

Common Problems

Enbrel Mini® single-dose prefilled cartridge is difficult to insert into the door.

Never force Enbrel Mini into the door. When positioned correctly, it will fall freely and completely into and out of the door. If it is difficult to load, double check that you are holding Enbrel Mini as shown.

• Purple cap is facing down
  
• Label facing outwards (away from the handle)

Injection does not start when pressing the status button.

Reason #1: Place the AutoTouch® reusable autoinjector on your skin and wait for the status button to turn green. A skin sensor is located on the injection end. You cannot start an injection unless the injection end of AutoTouch is touching your skin. Hold the injection end on your skin throughout the entire injection.

Reason #2: AutoTouch may be asleep. To conserve battery power, AutoTouch goes into a “sleep mode” after three minutes of no activity. If it seems unresponsive/asleep, remove AutoTouch from your skin and press the status button to wake it up.

Storage & Handling

Storage
AutoTouch® reusable autoinjector

Handling
AutoTouch reusable autoinjector

Storage and Handling
Enbrel Mini® single-dose prefilled cartridge

Cleaning Instructions

Cleaning
AutoTouch® reusable autoinjector

No modification of the AutoTouch® reusable autoinjector is allowed.

No part of AutoTouch can be repaired or replaced, including the battery.

Do not put anything inside the door other than an Enbrel Mini® single-dose prefilled cartridge.

Do not immerse AutoTouch in water.

Do not reach inside AutoTouch.

Do not crush, burn or heat AutoTouch.

AutoTouch contains moving parts. Keep your fingers out of openings in the injection end or open door.

Keep AutoTouch and Enbrel Mini out of the reach of children.

If AutoTouch fails, the maximum amount of medicine you could receive is the contents of the full Enbrel Mini, which is the correct dose.

Use caution if an error occurs as the needle may be exposed.

Carefully dispose of Enbrel Mini in an FDA approved sharps container.

Call your healthcare provider if you have any concerns regarding an incomplete injection. 

When travelling, keep AutoTouch with you, in your carry-on bags.

Do not dispose of AutoTouch in the household trash. Call 1-888-4ENBREL (1-888-436-2735) for a replacement.

International Protection Rating

The international protection code for the AutoTouch® reusable autoinjector when stored in its carton is IP52. Which means it is protected from limited dust ingress and from limited dripping water. AutoTouch is not rated for dust or fluid ingress when not stored in its carton.

Environmental Operating Range

AutoTouch will operate in the temperature range of 50° F to 104° F (10° C to 40° C), and 20% to 90% relative humidity, and at elevations from 197 feet below sea level to 11,483 feet above sea level (-60 m to 3500 m).

Environmental Storage Range

Transport and store AutoTouch in its carton, in a dry place at room temperature: 50° F to 104° F (10° C to 40° C). AutoTouch been tested to a brief exposure at -40° F to 158° F (-40° C to 70° C), 50% relative humidity, and pressure equivalent of 14000 ft (4267 m).

Electromagnetic Compatibility

Avoid operating AutoTouch near microwave ovens, wireless routers, baby monitors or other common household electronics that operate using RF transmission. Two meters (six feet) is a reasonable distance.

Avoid operating AutoTouch near high magnetic or other fields such as those around MRI, CAT, or PET scanners.

AutoTouch does not emit RF.

Electrical characteristics

The AutoTouch® reusable autoinjector uses a non-replaceable, non-rechargeable DL123 Lithium battery. The battery has a nominal voltage of 3.0 V with a capacity of 1400 mAh. The expected service life of AutoTouch is two years or 130 injections from the first injection.

AutoTouch has a Type BF applied part: it has a capacitive electrical sensor that is isolated by plastic from the skin.

Dimensions and weight

AutoTouch weighs 0.4 pounds (180 grams), and is 9 inches (228 mm) tall by 1.5 inches (38 mm) wide by 1.8 inches (45 mm) deep.

Biocompatibility and electrical isolation

The injection end of the reusable autoinjector is intended to come into contact with the skin (see Guide to parts). It is a Type BF applied part. This means that it is electrically isolated from the battery. The injection end and finger grip of AutoTouch are made of ABS plastic. This material has been biocompatibility-tested for skin sensitivity and irritation.

Symbol Table
	Do not re-use
	Use-by date (Exp. date)
	Lot number
	Keep dry
	Serial number
	Type BF applied part Injection end of device is a Type BF applied part.
	CAUTION, consult accompanying documents
	Refer to instructions for use
	Do not use if package is damaged
	This product contains dry natural rubber

AMGEN®

Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
©1998 – 2018 Immunex Corporation. All rights reserved.
[partnumber]
Revised: 12/2018 v5

AutoTouch Connect® reusable autoinjector
for use with
Enbrel Mini® (etanercept)
single-dose prefilled cartridge

User Manual

Getting Started

This User Manual contains helpful information about your AutoTouch Connect® reusable autoinjector (AutoTouch Connect). It includes resources, care details, and a troubleshooting guide to save for ongoing reference.

To learn how to inject using AutoTouch Connect, see your healthcare provider for injection training and use the Instructions for Use included in the carton.

Instructions for Use

A fold-out, step-by-step Instructions for Use is provided in the carton, which provides you with full instructions to learn how to give yourself a safe, successful and accurate injection.

Note: Please read the full Instructions for Use included in the carton.

The Reference Guide on the next page should only be used when you have successfully completed an injection using the Instructions for Use.

Reference Guide

Resources

ENBREL® SupportPlus provides personalized support services to ENBREL® patients, at no additional cost, including:

• Information about financial support options
• Supplemental injection training with an ENBREL Nurse Partner™
• Educational materials to help support you along the way

Call 1-888-4ENBREL (1-888-436-2735) to enroll or visit www.EnbrelSupportPlus.com to find out more.

Guide to Parts

AutoTouch Connect® reusable autoinjector

Finger grip

Door button

Press this button to open the door for insertion of the Enbrel Mini® single-dose prefilled cartridge. When your injection is finished, the door will open automatically.

Viewing window

During an injection, you can look through this window and see the plunger lowering to deliver your medicine. When AutoTouch Connect is awake, the viewing window will light up. If Enbrel Mini is in AutoTouch Connect, and the viewing window has no light, then press the status button to wake up AutoTouch Connect.

You will open this door and insert Enbrel Mini into AutoTouch Connect. The door will open automatically when your injection is finished. When inserted properly, Enbrel Mini will slide freely and completely into and out of the door.

Guide to Parts

AutoTouch Connect® reusable autoinjector

Status button

Press this button to begin an injection. Lights will indicate the status of your injection.

Green:
Ready to press and start injection.

Blinking green:
The needle is inserting and your injection is in progress.

Red:
An error has occurred. See the Troubleshooting section of this manual.

Progress bar

These stacked green bars are fully lit when your injection starts, and the bar of lights decrease as your injection is in progress. The lights will disappear when your injection is finished.

Speed switch

The AutoTouch Connect® reusable autoinjector allows you to choose from three injection speeds. The pre-set speed is medium.
(+) is faster
(•) is medium
(–) is slower

Guide to Parts

AutoTouch Connect® reusable autoinjector

Sound switch

Sounds can be turned off and on. (Sounds on) Slide switch down. (Sounds off) Slide switch up so that the red bar is visible.

Note: Error sounds will still be heard if the sounds have been turned off.

Injection end

The entire injection end must be touching your skin during injections. This is also where the needle will come out.

Skin sensor

A skin sensor is located on the injection end. When the injection end is placed on skin the start button light will turn green. Hold the injection end flat and steady on your skin throughout the entire injection process.

Site light

When the Enbrel Mini® single-dose prefilled cartridge is loaded and the purple cap is removed, the injection end will light up to help you see your injection site.

Guide to Parts

Enbrel Mini®
single-dose prefilled cartridge

Labeled side

When inserting the Enbrel Mini® cartridge make certain that the labeled side is facing out. Then slide Enbrel Mini into the door. It will slide all the way down into the AutoTouch Connect® reusable autoinjector.

Expiration date

Confirm expiration date printed on the label has not passed.

Enbrel Mini window

This is where you will look to examine your medicine before starting an injection. See Instructions for Use for more information.

Purple cap

The purple cap keeps your medicine safe. Do not remove the cap on Enbrel Mini before loading it into AutoTouch Connect. Load Enbrel Mini with the purple cap on, and remove the cap only when you are ready to give yourself the injection. Do not leave the purple cap off for more than five minutes. This can dry out the medicine.

See the Instructions for Use for more detail about loading Enbrel Mini and when to remove the purple cap.

Guide to Parts

AutoTouch Connect® reusable autoinjector

How it works.

When you push the status button to start an injection, the AutoTouch Connect® reusable autoinjector pushes a hidden needle out of the Enbrel Mini® single-dose prefilled cartridge into your skin. Then, a plunger rod will push into Enbrel Mini, injecting medicine into your body. After the medicine is injected, the rod will pull back up and the needle will withdraw from your skin. After a successful injection all lights will turn off and the door will open. The needle stays hidden at all times during the injection process.

What you will hear.

Needle insertion and plunger rod are operated by motors. You will hear a motor noise as the rod moves down and then back up again. Whenever you hear a motorized noise, you will know that an injection is in progress.

What you will see.

During the injection, the viewing window light will be on, and the plunger rod will move through the window. Also during the injection, the status light will be flashing green, and the progress bar will decrease. After a successful injection, the progress bar, and status button will turn off, and AutoTouch Connect will open the door.

If the status light turns red, and beeps for more than a few seconds, an error has occurred. Use the troubleshooting section of this manual to see what to do if this happens.

Troubleshooting:
Error Symbols

Error Symbols

The AutoTouch Connect® reusable autoinjector makes a chime sound, lights the status button red, and displays an error symbol if there is a problem.

See the following description of each error symbol, possible reasons for the error, and actions you can take.

Low battery

Symbol: Red battery and error sound.
Problem: The battery is running very low. Less than three weeks or three injections remain. The battery is not replaceable or rechargeable.
Action: Call 1-888-4ENBREL (1-888-436-2735) for a replacement AutoTouch Connect® reusable autoinjector.

Battery dead

Symbol: Red battery and red triangle with exclamation point, red status button, and error sound.
Problem: The AutoTouch Connect reusable autoinjector battery is dead.
Action: Call the 1-888-4ENBREL (1-888-436-2735) for a replacement AutoTouch Connect reusable autoinjector.

Too hot or cold

Symbol: Orange sun and a snowflake, and an error sound.
Problem: AutoTouch Connect is too hot or too cold. This will lock the door.
Action: Place AutoTouch Connect at room temperature in a safe, dry place and allow it to naturally cool or warm to room temperature. Then try again. Store the AutoTouch Connect reusable autoinjector in a dry, safe place, such as a cabinet or drawer at 50°F to 104°F (10°C to 40°C).

Troubleshooting:
Error Symbols

Enbrel Mini® problem

Symbol: Orange Enbrel Mini single-dose prefilled cartridge with blinking red status button and error alert sound.
Problem: There are five possible reasons you are getting this error. Please read below.

Problem #1: The purple cap was removed before inserting Enbrel Mini.
Action: Wait for the error to clear and close the door without Enbrel Mini in, and try again with a new Enbrel Mini. Make sure to leave the purple cap on until Enbrel Mini has been placed inside the AutoTouch Connect® reusable autoinjector and the door is closed. Call 1-888-4ENBREL (1-888-436-2735) for a replacement Enbrel Mini.

Problem #2: Sensor lost skin contact during injection.
Action: Hold the injection end of AutoTouch Connect on your skin throughout the entire injection until the green status button turns off, even if the motor sounds stop. Lifting or shifting on your skin during injection may lead to an incomplete injection. Call your healthcare provider if you feel you have given yourself an incomplete injection.

Problem #3: Enbrel Mini® single-dose prefilled cartridge is defective or not recognized as an Amgen product.
Action: Remove Enbrel Mini. Replace with a new Enbrel Mini. Call 1-888-4ENBREL (1-888-436-2735) for a replacement Enbrel Mini.

Problem #4: Door is held closed for more than one minute.
Action: Remove your hand from the door. When the door opens, remove Enbrel Mini from AutoTouch Connect®, if present. Wait for the error symbol to stop blinking and close the door. If you have not given yourself an injection, place a new Enbrel Mini in AutoTouch Connect and continue. If the error symbol remains on, call 1-888-4ENBREL (1-888-436-2735).

Problem #5: AutoTouch Connect has been dropped.
Action: A dropped AutoTouch Connect is not safe to use. Call 1-888-4ENBREL (1-888-436-2735) for a replacement.

Troubleshooting:
Error Symbols

Needle Exposure

Symbol: Orange Enbrel Mini® single-dose prefilled cartridge, a red triangle with an exclamation point, red status button, and error sound.
Problem: A problem occurred during an injection and the needle may be exposed.
Action: If there is still fluid in Enbrel Mini, an incomplete dose may have been injected. Call your healthcare provider if you feel you have given yourself an incomplete injection. Call 1-888-4ENBREL (1-888-436-2735) for further assistance with your AutoTouch Connect®.

Use caution when both Enbrel Mini problem symbol and the AutoTouch Connect reusable autoinjector failure symbols are lit as the needle may be exposed. Take special care when removing and handling Enbrel Mini. Remove Enbrel Mini then put it in an FDA-cleared sharps disposal container.

AutoTouch Connect® Reusable Autoinjector Failure

Symbol: Red triangle with an exclamation point, red status button, and error sound.
Problem: Several errors have occurred or AutoTouch Connect has stopped working.
Action: Reset AutoTouch Connect.

To reset AutoTouch Connect:

Hold AutoTouch Connect away from skin and press the status button to wake AutoTouch Connect. The failure symbol should begin blinking and a chime should sound.

While the failure symbol is blinking, press and hold door button until all symbols are temporarily displayed and the status button blinks green. The door button should be held for at least 10 seconds. After a successful reset, if an Enbrel Mini® single-dose prefilled cartridge is still inside AutoTouch Connect, remove it. Close the AutoTouch Connect door. Then, for the next injection, start by pressing the door button to open Enbrel Mini door.

If AutoTouch Connect does not respond after three attempts to reset, call 1-888-4ENBREL (1-888-436-2735).

Troubleshooting:
Common Problems

Common Problems

Enbrel Mini® single-dose prefilled cartridge is difficult to insert into the door.

Never force Enbrel Mini into the door. When positioned correctly, it will fall freely and completely into and out of the door. If it is difficult to load, double check that you are holding Enbrel Mini as shown.

• Purple cap is facing down
• Label facing outwards (away from the handle)

Injection does not start when pressing the status button.

Reason #1: Place the AutoTouch Connect® reusable autoinjector on your skin and wait for the status button to turn green. A skin sensor is located on the injection end. You cannot start an injection unless the injection end of AutoTouch Connect is touching your skin. Hold the injection end on your skin throughout the entire injection.

Reason #2: AutoTouch Connect may be asleep. To conserve battery power, AutoTouch Connect goes into a "sleep mode" after three minutes of no activity. If it seems unresponsive/asleep, remove AutoTouch Connect from your skin and press the status button to wake it up.

Reason: This will happen if the purple cap has been removed before inserting Enbrel Mini into the door. Do not reuse or recap. Begin again using a new Enbrel Mini.

Do not remove the purple cap until after Enbrel Mini has been inserted into AutoTouch Connect.

Troubleshooting:
Common Problems

Injection aborts or an error symbol appears while the injection is in process.

The AutoTouch Connect® reusable autoinjector will abort an injection if the sensor loses skin contact. Avoid adjusting or moving AutoTouch Connect during an injection. Hold AutoTouch Connect on your skin until the green status light turns off and the injection is finished. Shifting, repositioning or lifting from your skin during injection may lead to an incomplete dose.

Reason #1: At the end of an injection, the door cannot be closed with a used Enbrel Mini® single-dose prefilled cartridge inside.

Reason #2: When AutoTouch Connect experiences a failure, the door will open and remain open. If this occurs, call 1-888-4ENBREL (1-888-436-2735).

If the door is left open for more than 45 seconds, a chime will sound. Close the door to silence the chime.

The sound setting may be off. Turn on by sliding the sound switch down.

Enbrel Mini® single-dose prefilled cartridge will not eject.

Reason #1: If the viewing window has no light, press the status button to wake up AutoTouch Connect®. Then press and hold the door button for at least two seconds to eject.

Reason #2: If Enbrel Mini does not eject automatically at the end of an injection, there may be a problem. Call 1-888-4ENBREL (1-888-436-2735).

The purple cap should not be removed outside of the AutoTouch Connect reusable autoinjector. It should be removed after it is loaded into AutoTouch Connect, when you are ready to inject. If Enbrel Mini is loaded and the purple cap is difficult to remove, call 1-888-4ENBREL (1-888-436-2735).

Once the injection starts, the speed cannot be changed. Always set the speed prior to injection.

The speed switch may have been moved unintentionally. Check the speed setting prior to starting each injection.

Storage & Handling

Storage
AutoTouch Connect® reusable autoinjector

Handling
AutoTouch Connect reusable autoinjector

Storage and Handling
Enbrel Mini® single-dose prefilled cartridge

Cleaning Instructions

Cleaning
AutoTouch Connect® reusable autoinjector

Warnings

No modification of the AutoTouch Connect® reusable autoinjector is allowed.

No part of AutoTouch Connect can be repaired or replaced, including the battery.

Do not put anything inside the door other than an Enbrel Mini® single-dose prefilled cartridge.

Do not immerse AutoTouch Connect in water.

Do not reach inside AutoTouch Connect.

Do not crush, burn or heat AutoTouch Connect.

AutoTouch Connect contains moving parts. Keep your fingers out of openings in the injection end or open door.

Keep AutoTouch Connect and Enbrel Mini out of the reach of children.

If AutoTouch Connect fails, the maximum amount of medicine you could receive is the contents of the full Enbrel Mini, which is the correct dose.

Use caution if an error occurs as the needle may be exposed.

Carefully dispose of Enbrel Mini in an FDA approved sharps container.

Call your healthcare provider if you have any concerns regarding an incomplete injection.

When travelling, keep AutoTouch Connect with you, in your carry-on bags.

Do not dispose of AutoTouch Connect in the household trash. Call 1-888-4ENBREL (1-888-436-2735) for a replacement.

What is the Bluetooth® wireless feature?

This AutoTouch Connect® reusable autoinjector has a Bluetooth® wireless feature, which is designed to communicate wirelessly with an application on your mobile device to help you track your injections.

Currently, there is no mobile application available for use with this wireless feature. This wireless feature will not affect your injection steps.

You can inject without using the wireless feature. Always follow all steps found in the Instructions for Use.

Important Information Required by the Federal Communications Commission (FCC)

FCCID: 2AGZ4–ATCONNECT

The AutoTouch Connect® reusable autoinjector contains a Bluetooth® wireless feature.

AutoTouch Connect complies with Part 15 of the FCC Rules.

Operation is subject to the following two conditions:

1. AutoTouch Connect may not cause harmful interference.
2. AutoTouch Connect must accept any interference received, including interference that may cause undesirable operation.

Modification to AutoTouch Connect shall not be made without the written consent of Amgen.

Unauthorized modification may void the authority granted under FCC rules permitting the operation of AutoTouch Connect.

AutoTouch Connect has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. AutoTouch Connect generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.

If AutoTouch Connect® does cause harmful interference to radio or television reception, which can be determined by moving AutoTouch Connect far away and back, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between AutoTouch Connect and interference receiver.
• Consult the dealer or an experienced radio/TV technician for help.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth Special Interest Group (SIG) Inc. and any use of such marks by Amgen is under license. Other trademarks and trade names are those of their respective owners.

Technical Information

International Protection Rating

The international protection code for the AutoTouch Connect® reusable autoinjector when stored in its carton is IP52. Which means it is protected from limited dust ingress and from limited dripping water. AutoTouch Connect is not rated for dust or fluid ingress when not stored in its carton.

Environmental Operating Range

AutoTouch Connect will operate in the temperature range of 50°F to 104°F (10°C to 40°C), and 20% to 90% relative humidity, and at elevations from 197 feet below sea level to 11,483 feet above sea level (-60 m to 3500 m).

Environmental Storage Range

Transport and store AutoTouch Connect in its carton, in a dry place at room temperature: 50°F to 104°F (10°C to 40°C). AutoTouch Connect has been tested to a brief exposure at -40°F to 158°F (-40°C to 70°C), 50% relative humidity, and pressure equivalent of 14,000 feet (4267 m).

Bluetooth® Characteristics

The Bluetooth technology in the AutoTouch Connect complies with the Bluetooth Core Specification v5.0 and is qualified by Bluetooth SIG. The AutoTouch Connect has been designed to transmit default 0dBm standard industrial, scientific and medical (ISM) 2.4 GHz band radio frequency (RF) and covers up to 10 meters communication range.

Quality of Service and Security Information

The AutoTouch Connect autoinjector has a Bluetooth wireless feature to establish an authenticated and encrypted connection with a Bluetooth capable device (e.g. mobile application). Initial setup requires physical access to the autoinjector labeled serial number for user input at initial pairing/secure bonding. There is no mobile application currently available.

Data is transferred from the autoinjector on a one-to-one paired mobile device for ensuring data integrity and quality of service (QoS). Data transferred is read-only and no patient information is stored on the autoinjector.

Data can be sent at any time, and temporary loss of proper QoS will be resolved upon resumed connection to the app. If connection with the app drops and re-establishes, data transfer resumes with data integrity verification. Data transfer latency or asynchronization does not affect drug delivery tracking as data will be confirmed upon reconnection.

Electromagnetic Compatibility

Portable and mobile RF communications equipment can affect medical electrical equipment. Avoid operating AutoTouch Connect® near microwave ovens, wireless routers, baby monitors or other common household electronics that operate using RF transmission, including RFID emitters. A minimum distance of 30 cm (12 inches) is recommended.

Avoid operating AutoTouch Connect near high magnetic or other fields such as those around MRI, CAT, or PET scanners.

AutoTouch Connect emits RF.

Electromagnetic Emissions

Electromagnetic Immunity

Electrical characteristics

The AutoTouch Connect® reusable autoinjector uses a non-replaceable, non-rechargeable DL123 Lithium battery. The battery has a nominal voltage of 3.0 V with a capacity of 1400 mAh.

The autoinjector enclosure is a Type BF applied part:
The skin sensor and other electronics are isolated from the skin.

Dimensions and weight

AutoTouch Connect weighs 0.4 pounds (180 grams), and is 9 inches (228 mm) tall by 1.5 inches (38 mm) wide by 1.8 inches (45 mm) deep.

Biocompatibility and electrical isolation

The autoinjector enclosure is intended to come into contact with the skin (see Guide to Parts). It is a Type BF applied part. This means that it is electrically isolated from the battery. The injection end and finger grip of AutoTouch Connect® are made of ABS plastic. This material has been biocompatibility-tested for skin sensitivity and irritation.

Contraindications

This device is contraindicated for use in a Magnetic Resonance (MR) environment. For contraindications of ENBREL® please refer to ENBREL prescribing information.

Symbol Table

	Do not re-use
	Use-by date (Exp. date)
	Lot number
	Keep dry
	Serial number
	Type BF applied part The autoinjector enclosure is a Type BF applied part.
	CAUTION, consult accompanying documents
	Refer to instructions for use
	Do not use if package is damaged
	Magnetic Resonance (MR) Unsafe

AMGEN®

Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
©2021-2024 Immunex Corporation.
All rights reserved.
[partnumber]
Revised: 07/2024 v3

This printed material is recyclable.

Read this Instructions for Use before you start taking Enbrel and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition and treatment.

Step 1: Set up

1a. Strength and dose

The strength of the Enbrel single-dose vial is different than the Enbrel multiple-dose vial.

Each single-dose vial contains 25 mg (0.5 mL).

Review your prescription carefully for dose and dosing schedule. Only inject Enbrel after you or your caregiver has received training by your healthcare provider. Your healthcare provider will tell you how often you should use Enbrel. Do not use Enbrel more often than directed by your healthcare provider. If you forget to use Enbrel, inject your dose right away. Inject your next dose at your regular scheduled time. If you do not know when to inject Enbrel, call your healthcare provider or pharmacist.

Keep Enbrel out of the reach of children.

1b. Store Enbrel single-dose vials

Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C). You may also store the Enbrel single-dose vials at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days. Throw away Enbrel that has been stored at room temperature after 30 days.

Do not shake.

Do not freeze or store in extreme heat or cold.

Store Enbrel in the original carton to protect from light or damage.

1c. Remove correct number of vials

Remove the correct number of Enbrel single-dose vials from the original carton.

Check your prescription to determine if your dose will require 1 or 2 single-dose vials.

Your dose is determined in milliliters (mL).

Your child's dose of Enbrel depends on his or her weight. Your child's healthcare provider will tell you which form of Enbrel to use and how much to give your child.

1d. Inspect the single-dose vial(s)

Leave the single-dose vial(s) at room temperature, with the green cap(s) on, for at least 30 minutes.

Enbrel is clear and colorless. There may be small white particles in the solution. Check the expiration date.

Keep out of direct sunlight.

Do not use Enbrel if:

• the expiration date has passed
• the green cap is not attached
• it has lumps, is discolored, or is cloudy.

If there are any issues with your Enbrel single-dose vials, please call 1-888-4ENBREL (1-888-436-2735).

1e. Gather all materials and wash hands

Wash your hands with soap and water.

Place the following items on a clean well-lit, flat surface:

• 1 mL syringe
• Long needle: for withdrawal
• Short needle: for injection
• Alcohol wipes
• Cotton balls
• Bandage
• Sharps disposal container

1f. Pop off the green vial cap then wipe the gray stopper

Use an alcohol wipe to clean the gray stopper.

If you require a second single-dose vial, clean the gray stopper of the second single-dose vial with a new alcohol wipe.

1g. Attach the long needle to the syringe

Twist the long needle onto the syringe.

Step 2: Prepare dose

2a. Pull plunger back, insert needle, and push air into single-dose vial

Pull the needle cap straight off and away from your body. Save the needle cap for later.

Pull the syringe plunger back to 0.5 mL.

Hold the single-dose vial on a flat surface with 1 hand. Insert the long needle through the gray rubber stopper above the medicine in the single-dose vial.

Slowly push 0.5 mL of air into the single-dose vial.

2b. Tilt the single-dose vial to withdraw all medicine

Slowly pull back the plunger to fill the syringe with all the medicine from the single-dose vial.

Remove needle from the single-dose vial.

The air in the syringe will be removed later.

2c. Gently tap the syringe with fingers to release bubbles

Gently tap the syringe with your fingers to release air pockets and bubbles until they rise to the top of the syringe.

2d. Push out large air pockets and bubbles

After you have gently tapped the large air pockets and bubbles to the top of the syringe, push the plunger up to remove the air out of the syringe.

Small amounts of tiny air bubbles are ok.

If you need 1 single-dose vial, push the plunger to your total prescribed dose and continue to step 2g.

If you need more than 1 single-dose vial to get your total prescribed dose, follow these 2 steps:

2e. Insert the same needle in the second vial Tilt vial to withdraw medicine. Slowly pull back the plunger to fill the syringe with all medicine from the vial. Remove the needle from the single-dose vial. The air will be removed in the next step	2f. Gently tap the syringe to remove the air Hold the needle pointing up and gently tap the syringe so air bubbles rise to the top. Push the plunger to your prescribed dose. Small amounts of tiny air bubbles are ok.
2g. Use 1-handed scoop method to recap For your safety, place the needle cap on a flat surface.

Using 1 hand, slide the needle into the cap and scoop upwards to cap the needle, without using your other hand.

Then use your other hand to secure the cap and snap into place.

Step 3: Inject and throw away

3a. Replace the long needle with the short needle

Twist the long needle off of the syringe.

Throw away the long needle in the sharps disposal container.

Twist the short needle onto the syringe.

Do not remove the needle cover until you are ready to inject.

3b. Choose and clean the injection site

• thigh or stomach (avoid 2 inches around the navel)
• back of upper arm (only if someone else is giving the injection)

Choose a different site each time you give yourself an injection. Avoid injecting into tender, raised, red or scaly skin.

Clean the injection site with an alcohol wipe and let dry. Do not touch this area again before injecting.

3c. Pinch and inject Enbrel

Gently pinch skin. With a quick firm action, insert the needle into your skin at a 45-degree angle.

When the needle is completely inserted into the skin, slowly push the plunger all the way down.

When the syringe is empty, remove the needle and syringe from your skin. Do not recap the needle.

Do not rub the injection site. If you see drops of blood at the injection site, you can press a cotton ball over the injection site until bleeding has stopped. Apply an adhesive bandage, if needed.

3d. Throw away the used single-dose vials, needles and syringe

Single-dose vials do not contain preservatives and are for 1-time use only. Unused medicine in the single-dose vials must be thrown away in a sharps disposal container.

Additional disposal information

Do not throw away the vials, needles, and syringe in your household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic
• can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out
• upright and stable during use
• leak-resistant
• properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to throw away your sharps disposal container. There may be state or local laws about how you should throw away used vials, needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal

• Do not throw away your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
• Do not reuse the vials, syringe, or needles.
• Do not recycle the vials, syringe, needles, or sharps disposal container or throw them into household trash.

Important: Always keep the sharps disposal container out of the reach of children.

If you experience any difficulty using your Enbrel single-dose vials, please call 1-888-4ENBREL (1-888-436-2735).

If you have any questions about your Enbrel dosing, please call your healthcare provider.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

AMGEN®

Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
© 1998-2020, 2022 Immunex Corporation. All rights reserved.
[part number]
Revised: 06/2022 v2

This printed material is recyclable.

Front Panel

REFERENCE GUIDE

Guide to parts	Wait at least 30 minutes for the autoinjector to come to room temperature before giving your injection.	Pull the white cap straight off only when you are ready to inject. Do not leave the white cap off for more than 5 minutes. This can dry out the medicine.
	Prepare and clean your injection site.	2
	1		5 minutes
			Turn over to continue

Side 2	Reference Guide Enbrel® (en-brel) (etanercept) injection, for subcutaneous use Single-Dose Prefilled SureClick® Autoinjector 50 mg/mL		AMGEN®		Read other side first
			Manufactured by: Immunex Corporation Thousand Oaks, CA 91320-1799 © 1998, 2019, 2021-2022 Immunex Corporation. All rights reserved. <part number> Revised: 8/2022 v9 This printed material is recyclable.
Stretch or pinch your injection site to create a firm surface.		Put the green safety guard (needle inside) on your skin at 90 degrees.	Firmly push down the autoinjector onto your skin until it stops moving.	Keep pushing down on your skin for about 15 seconds.
3		4	5	6
Stretch method:			When you are ready to inject, press the purple start button. You will hear a click.	15 seconds Window turns from clear to yellow when the injection is done.
Pinch method:	or

PRINCIPAL DISPLAY PANEL
Contains 4 Single-Dose Prefilled Syringes
NDC 58406-455-04
Enbrel®
etanercept
25 mg/0.5 mL
Single-Dose Prefilled Syringe
25 mg/0.5 mL
Attention: Not for use in pediatric patients under 31 kg (68 pounds).
For Subcutaneous Use Only
Sterile Solution – No Preservative
Refrigerate at 2° to 8°C (36° to 46°F). DO NOT FREEZE. 
Carton contents (4 single-dose prefilled syringes, 1 package
insert with attached Medication Guide) are intended to be
dispensed as a unit.
ATTENTION: Enclosed Medication Guide is required
for each patient.
This Product Contains Dry Natural Rubber.
AMGEN®
Rx Only
Manufactured by Immunex Corporation, Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL
Contains 4 Single-Dose Prefilled Syringes
NDC 58406-435-04
Enbrel®
etanercept
50 mg/mL
Single-Dose Prefilled Syringe
50 mg/mL
Attention: Not for use in pediatric patients under 63 kg (138 pounds).
For Subcutaneous Use Only
Sterile Solution – No Preservative
Refrigerate at 2° to 8°C (36° to 46°F). DO NOT FREEZE.
Carton contents (4 single-dose prefilled syringes, 1 package
insert with attached Medication Guide) are intended to be
dispensed as a unit.
ATTENTION: Enclosed Medication Guide is required
for each patient.
This Product Contains Dry Natural Rubber.
AMGEN®
Rx Only
Manufactured by Immunex Corporation, Thousand Oaks, CA 91320

Contains 4 Single-Dose Prefilled Syringes

NDC 58406-010-04

Enbrel®
etanercept

25
mg/0.5 mL

Not made with
natural rubber latex

25 mg/0.5 mL
Single-Dose Prefilled Syringe

Attention: Not for use in pediatric patients under 31 kg (68 pounds).
For Subcutaneous Use Only
Sterile Solution – No Preservative
Refrigerate at 2° to 8°C (36° to 46°F). DO NOT FREEZE.

Each single-dose prefilled syringe contains 0.5 mL of a clear and
colorless solution containing 25 mg/0.5 mL etanercept and is formulated at
pH 6.3 ± 0.2, with 25 mM L-arginine hydrochloride, 120 mM sodium chloride,
and 1% sucrose.

Specific activity: approximately 1.7 x 106 U/mg.

Manufactured by Immunex Corporation, Thousand Oaks, CA 91320
U.S. License No. 1132

©2013, 2017, 2022-2023 Immunex Corporation
Patent: http://pat.amgen.com/enbrel/

This carton is recyclable.

Contains 4 Single-Dose Prefilled Syringes

NDC 58406-021-04

Enbrel®
etanercept

50
mg/mL

Not made with
natural rubber latex

50 mg/mL
Single-Dose Prefilled Syringe

Attention: Not for use in pediatric patients under 63 kg (138 pounds).
For Subcutaneous Use Only
Sterile Solution – No Preservative
Refrigerate at 2° to 8°C (36° to 46°F). DO NOT FREEZE.

Each single-dose prefilled syringe contains 1 mL of a clear and
colorless solution containing 50 mg/mL etanercept and is formulated at
pH 6.3 ± 0.2, with 25 mM L-arginine hydrochloride, 120 mM sodium chloride,
and 1% sucrose.

Specific activity: approximately 1.7 x 106 U/mg.

Manufactured by Immunex Corporation, Thousand Oaks, CA 91320
U.S. License No. 1132

©2013, 2017, 2022-2023 Immunex Corporation
Patent: http://pat.amgen.com/enbrel/

This carton is recyclable.

PRINCIPAL DISPLAY PANEL
Contains 4 Single-Dose Prefilled Autoinjectors
NDC 58406-445-04
Enbrel®
etanercept
SureClick® Autoinjector
50 mg/mL
Single-Dose Prefilled Autoinjector
50 mg/mL
Attention: Not for use in pediatric patients under 63 kg (138 pounds).
For Subcutaneous Use Only
Sterile Solution – No Preservative
Refrigerate at 2° to 8°C (36° to 46°F). DO NOT FREEZE.
Carton Contents (4 prefilled SureClick® Autoinjectors, 1 package insert with
attached Medication Guide) are intended to be dispensed as a unit.
ATTENTION: Enclosed Medication Guide is required for each patient.
This Product Contains Dry Natural Rubber.
AMGEN®
Rx Only
Manufactured by Immunex Corporation, Thousand Oaks, CA 91320-1799

Contains 4 Single-Dose Prefilled Autoinjectors

NDC 58406-032-04

Enbrel®
etanercept

50
mg/mL

Not made with
natural rubber latex

SureClick® Autoinjector
50 mg/mL
Single-Dose Prefilled Autoinjector

Attention: Not for use in pediatric patients under 63 kg (138 pounds).
For Subcutaneous Use Only
Sterile Solution – No Preservative
Refrigerate at 2° to 8°C (36° to 46°F). DO NOT FREEZE.

Each single-dose prefilled autoinjector contains 1 mL of a clear and colorless solution containing
50 mg/mL etanercept and is formulated at pH 6.3 ± 0.2, with 25 mM L-arginine hydrochloride,
120 mM sodium chloride, and 1% sucrose.

Specific activity: approximately 1.7 x 106 U/mg.

Manufactured by Immunex Corporation, Thousand Oaks, CA 91320-1799
U.S. License No. 1132

©2015, 2017, 2022-2023 Immunex Corporation
Patent: http://pat.amgen.com/enbrel/

This carton is recyclable.

PRINCIPAL DISPLAY PANEL
Contains 4 Multi-Dose Trays
NDC 58406-425-34
AMGEN®
Enbrel®
etanercept
25 mg/vial
Multiple-Dose Vial
See package insert for full prescribing information
and instructions for preparation and administration.
25 mg/vial
Each vial contains a sterile lyophilized preparation
of 25 mg etanercept (a recombinant CHO cell-derived
product), 40 mg mannitol, 10 mg sucrose, and
1.2 mg tromethamine.
Specific activitiy: approximately 1.7 x 106 U/mg.
No U.S. standard of potency. Volume after reconstitution
with 1 mL diluent is 1 mL.
Before and after reconstitution refrigerate
at 2° to 8°C (36° to 46°F). DO NOT FREEZE.
For Subcutaneous Use Only
AMGEN®
Manufactured by Immunex Corporation, Thousand Oaks, CA 91320
Contains diluent syringes (Made in Germany)
U.S. License No. 1132
©2013, 2016 Immunex Corporation
Patent: http://pat.amgen.com/enbrel/

PRINCIPAL DISPLAY PANEL
Contains 4 Single-dose prefilled cartridges
NDC 58406-456-04
Enbrel®
etanercept
50 mg/mL
Enbrel Mini™ prefilled cartridge
50 mg/mL
Single-dose prefilled cartridge
For use with AutoTouch™ reusuable autoinjector only
Attention: Not for use in pediatric patient under 138 lbs.
For Subcutaneous Use Only
Sterile Solution – No Preservative
Refrigerate at 2°C to 8°C (36° to 46°F). DO NOT FREEZE. DO NOT SHAKE.
Carton contents (4 prefilled cartridges, 1 package insert with attached
Medication Guide) are intended to be dispensed as a unit.
ATTENTION: Enclosed Medication Guide is required for each patient.
This Product Contains
Dry Natural Rubber.
Do not Reuse
CAUTION, See package insert
for full prescribing information
and Instructions for Use
Rx Only
AMGEN®

Contains 4 Single-dose prefilled cartridges

NDC 58406-044-04

Enbrel®
etanercept

50
mg/mL

Not made with
natural rubber latex

Enbrel Mini® prefilled cartridge
50 mg/mL
Single-dose prefilled cartridge
For use with all AutoTouch® reusable autoinjectors only

Attention: Not for use in pediatric patient under 138 lbs.
For Subcutaneous Use Only
Sterile Solution – No Preservative
Refrigerate at 2° to 8°C (36° to 46°F). DO NOT FREEZE. DO NOT SHAKE.

Carton contents (4 prefilled cartridges, 1 package insert with attached
Medication Guide) are intended to be dispensed as a unit.

ATTENTION: Enclosed Medication Guide is required for each patient.

Do not Reuse

CAUTION, See package insert
for full prescribing information
and Instructions for Use

Rx Only

AMGEN®

↓ OPEN HERE ↓

PRINCIPAL DISPLAY PANEL
NDC 58406-470-01

AMGEN®

AutoTouch® reusable autoinjector

For use with Enbrel Mini® (etanercept)

For use with Enbrel Mini® (etanercept) single-dose prefilled cartridge

Contains 1 AutoTouch® reusable autoinjector

For Subcutaneous Use Only

Store at room temperature.

IP52 – This package will resisit drops of water and dust.

Do Not Use if Package is Damaged

Type BF Applied Part

Exp: Expiry Date

Follow instructions for use

Rx Only

NDC 58406-480-01

AMGEN®

Bluetooth®

AutoTouch Connect™
reusable autoinjector

For use with Enbrel Mini® (etanercept)
single-dose prefilled cartridge

Contains 1 AutoTouch Connect™ reusable autoinjector
For Subcutaneous Use Only

Store in a dry place at room temperature: 50°F to 104°F (10°C to 40°C)
IP52 – This package will resisit drops of water and dust.

Do Not Use if Package is Damaged
Type BF Applied Part
MR unsafe
Exp: Expiry Date
Follow instructions for use

Rx Only

4 Single-Dose Vials, each vial is 25 mg/0.5mL
NDC 58406-055-04

AMGEN®

Enbrel®
etanercept
Injection

25
mg

25 mg/0.5 mL
Single-Dose Vial – Discard unused portion

For Subcutaneous Use Only.
Sterile Solution - No Preservative.
Store refrigerated at 2° to 8°C (36° to 46°F). DO NOT FREEZE.
DO NOT SHAKE.
Protect from Light.

U.S. License No. 1132
Manufactured by Immunex Corporation
Thousand Oaks, CA 91320-1799 U.S.A.
© 2020, 2022-2023 Immunex Corporation

Rx Only