HUMIRA- adalimumab   
HUMIRA- adalimumab injection, solution 
AbbVie Inc.

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MEDICATION GUIDE

HUMIRA® (Hu-MARE-ah)

(adalimumab)

injection

Read the Medication Guide that comes with HUMIRA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about HUMIRA?

HUMIRA is a medicine that affects your immune system. HUMIRA can lower the ability of your immune system to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

Before starting HUMIRA, tell your doctor if you:

After starting HUMIRA, call your doctor right away if you have an infection, or any sign of an infection.

HUMIRA can make you more likely to get infections or make any infection that you may have worse.

Cancer

See the “What are the possible side effects of HUMIRA?” section.

What is HUMIRA?

HUMIRA is a medicine called a Tumor Necrosis Factor (TNF) blocker. HUMIRA is used:

What should I tell my doctor before taking HUMIRA?

HUMIRA may not be right for you. Before starting HUMIRA, tell your doctor about all of your health conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you use:

Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take HUMIRA?

What are the possible side effects of HUMIRA?

HUMIRA can cause serious side effects, including:

See “What is the most important information I should know about HUMIRA?”

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with HUMIRA may be stopped.

Common side effects with HUMIRA include:

These are not all the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store HUMIRA?

General information about HUMIRA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use HUMIRA for a condition for which it was not prescribed. Do not give HUMIRA to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about HUMIRA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about HUMIRA that was written for healthcare professionals.

For more information go to www.HUMIRA.com or you can enroll in a patient support program by calling 1-800-4HUMIRA (1-800-448-6472).

What are the ingredients in HUMIRA?

Active ingredient: adalimumab

Inactive ingredients: sodium chloride, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dihydrate, sodium citrate, citric acid monohydrate, mannitol, polysorbate 80, and Water for Injection. Sodium hydroxide is added as necessary to adjust pH.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

AbbVie Inc.

North Chicago, IL 60064, U.S.A.

Content revised 05/2013

INSTRUCTIONS FOR USE

HUMIRA® (Hu-MARE-ah)

(adalimumab)

SINGLE-USE PEN

Do not try to inject HUMIRA yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of HUMIRA at home, you should receive training on the right way to prepare and inject HUMIRA. It is important that you read, understand, and follow these instructions so that you inject HUMIRA the right way. Call your healthcare provider if you or your caregiver has any questions about the right way to inject HUMIRA.

IMPORTANT:

See the section below called “Prepare the HUMIRA Pen”.

How should I store HUMIRA?

Gather the Supplies for Your Injection

If you do not have all of the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. The diagram below shows what the HUMIRA Pen looks like. See Figure A.

Figure A

fig-a-pen-image

Check the carton, dose tray, and HUMIRA Pen.

1. Make sure the name HUMIRA appears on the carton, dose tray, and HUMIRA Pen label.

2. Do not use and call your doctor or pharmacist if:

3. Hold the Pen with the gray cap (Cap # 1) pointed down.

4. Make sure the amount of liquid in the Pen is at the fill line or close to the fill line seen through the window. This is the full dose of HUMIRA that you will inject. See Figure B.

5. If the Pen does not have the full amount of liquid, do not use that Pen. Call your pharmacist.

Figure B

fig-b-pen-with-window

6. Turn the Pen over and hold the Pen with the gray cap (Cap # 1) pointed up. See Figure C.

7. Check the solution through the windows on the side of the Pen to make sure the liquid is clear and colorless. Do not use your HUMIRA Pen if the liquid is cloudy, discolored, or if it has flakes or particles in it. Call your pharmacist. It is normal to see one or more bubbles in the window.

Figure C

humira-fig-c-hand-with-pen-b

Choose the Injection Site

8. Wash and dry your hands well.

9. Choose an injection site on:

Prepare the Injection Site

10. Wipe the injection site with an alcohol prep (swab) using a circular motion.

Preparing the HUMIRA Pen

11. Do not remove the gray cap (Cap # 1) or the plum-colored cap (Cap # 2) until right before your injection.

12. Hold the middle of the Pen (gray body) with one hand so that you are not touching the gray cap (Cap # 1) or the plum-colored cap (Cap # 2). Turn the Pen so that the gray cap (Cap # 1) is pointing up. See Figure E.

Figure E

humira-pen-fig-e-hand-hold-gray-cap-b

13. With your other hand, pull the gray cap (Cap # 1) straight off (do not twist the cap). Make sure the small gray needle cover of the syringe has come off with the gray cap (Cap # 1). See Figure F.

14. Throw away the gray cap (Cap # 1).

Figure F

humira-pen-fig-f-gray-cap-removal-b

15. Remove the plum-colored cap (Cap # 2) from the bottom of the Pen by pulling it straight off (do not twist the cap). The Pen is now activated. Throw away the plum-colored cap.

The plum-colored activator button:

Figure G

humira-pen-fig-g-plum-cap-removal-b

Figure H

humira-pen-figure-h

Position the Pen and Inject HUMIRA

16. Position the Pen:

Figure I

Squeezed Skin

17. Place the white end of the Pen straight (at a 90º angle) and flat against the raised area of your skin that you are squeezing. Place the Pen so that it will not inject the needle into your fingers that are holding the raised skin. See Figure J.

Figure J

humira-pen-figure-j-90degree-inj-angle

18. Inject HUMIRA

Figure L

fig-l-yellow-indicator

19. When the injection is finished, slowly pull the Pen from your skin. The white needle sleeve will move to cover the needle tip. See Figure M.

20. Dispose of your used HUMIRA Pen. See the section “How should I dispose of the used HUMIRA Pen?”

21. Keep a record of the dates and location of your injection sites. To help you remember when to take HUMIRA, you can mark your calendar ahead of time.

How should I dispose of the used HUMIRA Pen?



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

AbbVie Inc.

North Chicago, IL 60064, U.S.A.

Content revised 07/2013


INSTRUCTIONS FOR USE

HUMIRA® (Hu-MARE-ah)

(adalimumab)

SINGLE-USE PREFILLED SYRINGE

Do not try to inject HUMIRA yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of HUMIRA at home, you should receive training on the right way to prepare and inject HUMIRA. It is important that you read, understand, and follow these instructions so that you inject HUMIRA the right way. Call your healthcare provider if you or your caregiver has any questions about the right way to inject HUMIRA.

How should I store HUMIRA?

Gather the Supplies for Your Injection

If you do not have all of the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist.

The diagram below shows what a prefilled syringe looks like. See Figure A.

Figure A

Syringe Image

Check the carton, dose tray, and prefilled syringe

1. Make sure the name HUMIRA appears on the dose tray and prefilled syringe label.

2. Do not use and call your doctor or pharmacist if:

Choose the Injection Site

3. Wash and dry your hands well.

4. Choose an injection site on:

Prepare the Injection Site

5. Wipe the injection site with an alcohol prep (swab) using a circular motion.

6. Do not touch this area again before giving the injection. Allow the skin to dry before injecting. Do not fan or blow on the clean area.

Prepare the Syringe and Needle

7. Check the fluid level in the syringe:

Figure D

Syringe Adult and Pediatric

8. The top of the liquid may be curved. If the syringe does not have the correct amount of liquid, do not use that syringe. Call your pharmacist.

9. Remove the needle cover:

10. Turn the syringe so the needle is facing up and hold the syringe at eye level with one hand so you can see the air in the syringe. Using your other hand, slowly push the plunger in to push the air out through the needle. See Figure F.

Figure F

Syringe Push Air Out

Position the Prefilled Syringe and Inject HUMIRA

Position the Syringe

11. Hold the body of the prefilled syringe in one hand between the thumb and index finger. Hold the syringe in your hand like a pencil. See Figure G.

Figure G

Syringe Hold like Pencil

Figure H

Squeeze Skin

Inject HUMIRA

12. Using a quick, dart-like motion, insert the needle into the squeezed skin at about a 45-degree angle. See Figure I.

Figure I

Syringe Injection Angle

If blood appears in the syringe:

If no blood appears in the syringe:

13. Throw away the used prefilled syringe and needle. See “How should I dispose of used prefilled syringes and needles?”

14. Keep a record of the dates and location of your injection sites. To help you remember when to take HUMIRA, you can mark your calendar ahead of time.

How should I dispose of used prefilled syringes and needles?


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

AbbVie Inc.

North Chicago, IL 60064, U.S.A.

Content revised 01/2013

Revised: 05/2014
 
AbbVie Inc.