Alhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:

•

hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors

•

hemophilia B (congenital factor IX deficiency) with FIX inhibitors

Alhemo injection is a clear to slightly opalescent and colorless to slightly yellow solution that may contain translucent to white particles, available in the following presentations:

•

60 mg/1.5 mL (40 mg/mL) in a single-patient-use prefilled pen

•

150 mg/1.5 mL (100 mg/mL) in a single-patient-use prefilled pen

•

300 mg/3 mL (100 mg/mL) in a single-patient-use prefilled pen

Alhemo is contraindicated in patients with a history of known serious hypersensitivity to Alhemo or its components or the inactive ingredients [see Warnings and Precautions (5.1) and Description (11)].

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

•

Thromboembolic Events [see Warnings and Precautions (5.1)]

•

Hypersensitivity Reactions [see Warnings and Precautions (5.2)]

•

Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment 1+2 [see Warnings and Precautions (5.3)]

Concizumab-mtci, is a humanized IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells with an approximate molecular weight of 149 kDa.

Alhemo (concizumab-mtci) injection is a clear to slightly opalescent, and colorless to slightly yellow solution that may contain translucent to white particles. Alhemo is supplied as a single-patient-use prefilled pen for subcutaneous injection.

Each 1 mL of Alhemo single-patient-use prefilled pen (60 mg/1.5 mL) contains 40 mg active ingredient concizumab-mtci. Each 1 mL of Alhemo single-patient-use prefilled pen (150 mg/1.5 mL) contains 100 mg active ingredient concizumab-mtci. Each 1 mL of Alhemo single-patient-use prefilled pen (300 mg/3 mL) contains 100 mg active ingredient concizumab-mtci.

Each 1 mL of Alhemo single-patient-use prefilled pen contains the following excipients: arginine hydrochloride (5.27 mg), histidine (5.12 mg), phenol (3.5 mg), polysorbate 80 (0.25 mg), sodium chloride (1.46 mg), sucrose (51.3 mg), and water for injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH to 6.0.

Hemophilia A and B with Inhibitors in Patients ≥12 Years of Age (explorer7)

The efficacy of Alhemo in patients with hemophilia A and B with inhibitors was evaluated in the explorer7 trial (NCT04083781), a multi-national, multi-center, open-label, phase 3 trial that investigated the safety and efficacy of Alhemo for routine prophylaxis in 91 adults (58 HAwI and 33 HBwI) and 42 adolescents (22 HAwI and 20 HBwI) male patients with hemophilia A or B with inhibitors who have been prescribed, or are in need of, treatment with bypassing agents. Eptacog alfa was the rFVIIa used in explorer7. Patients were excluded if they had a history, current signs or symptoms, or at high risk of thromboembolic events, ongoing or planned immune tolerance induction treatment, in addition to patients with planned major surgery.

Among the 133 patients treated with Alhemo in the trial the mean age was 29 years (range: 12 to 79); 42 patients were 12 to <18 years of age, 89 patients were 18 to 64 years of age, and 2 patients were ≥65 years of age, and all were male. Seventy-eight (78) patients were White, 37 patients were Asian, 9 patients were Black or African American, 6 patients had race information unreported, and 3 patients were American Indian or Alaska Native; 6 patients identified as Hispanic or Latino, 122 patients identified as not Hispanic or Latino and 5 patients had ethnicity information unreported.

The trial was comprised of 4 arms, two randomized arms and two non-randomized arms:

• Arms 1 and 2: 52 patients (27 HAwI, and 25 HBwI), previously treated on-demand, were randomized 1:2 to no prophylaxis (arm 1: on demand treatment with bypassing agents) or Alhemo prophylaxis (arm 2), with stratification by hemophilia type (HAwI, HBwI) and prior 24-week bleeding rate (< 9 or ≥9)

• Arms 3 and 4: 81 additional patients (53 HAwI and 28 HBwI) treated with Alhemo prophylaxis

Treatment with Alhemo included a loading dose of 1 mg/kg on the first day and a once-daily dose of 0.20 mg/kg starting on the second day. The dose was individualized to 0.25 mg/kg or 0.15 mg/kg if Alhemo plasma concentration measured once after 4 weeks of treatment was <200 ng/mL or >4000 ng/mL, respectively. Measurement of concizumab-mtci plasma concentration after 4 weeks was used to optimize the daily maintenance dose. In the trial, a total of 108 patients received their individualized dose, 1 patient on 0.15 mg/kg, 79 patients on 0.20 mg/kg and 28 patients on 0.25 mg/kg.

Efficacy was evaluated in hemophilia A and B patients with inhibitors when all patients in arms 1 and 2 had completed at least 24 or at least 32 weeks, respectively), by comparing the number of treated bleeding episodes between Alhemo prophylaxis (arm 2) and no prophylaxis (arm 1). Using a negative binomial model, a ratio of the annualized bleeding rates (ABR) was estimated to 0.14 (p<0.001), corresponding to a reduction in ABR of 86% for subjects on Alhemo prophylaxis compared to no prophylaxis. The estimated mean ABR was 1.7 [95%CI: 1.01; 2.87] for patients on Alhemo prophylaxis (arm 2) and 11.8 [95%CI: 7.03; 19.86] for patients on no prophylaxis (arm 1).

How Supplied

Alhemo (concizumab-mtci) injection is a clear to slightly opalescent, colorless to slightly yellow liquid, that may contain translucent to white particles. Alhemo is available as one single-patient-use prefilled pen per carton in the following presentations (see Table 3):

Table 3Alhemo Presentations

Storage and Handling

Before first use: Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze.

After first use: Store in a refrigerator at 36℉ to 46˚F (2℃ to 8˚C) or at room temperature below 86˚F (30˚C) for up to 28 days. Write the date of first use in the space provided on the carton. Discard the unused portion of the pen 28 days after first opening.

Store Alhemo with the cap on and in the original carton to protect from light. Alhemo should not be stored in direct sunlight, and the Alhemo pen should be kept away from direct heat. Do not freeze or store it close to a cooling element in a refrigerator (the part that cools the refrigerator). Do not use Alhemo if it has been frozen or stored at temperatures above 86˚F (30˚C).

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

•

Thromboembolic events: Inform patients of the signs and symptoms of thromboembolic events, including swelling, warmth, pain, or redness of the skin (and that these could be symptoms of a blood clot in the legs or arms); shortness of breath or severe chest pain (and that these could be symptoms of blood clots in the chest [heart and lungs]).; headache, confusion, difficulty with speech or movement, numbness of the face, eye pain or swelling, or vision problems (and that these could be symptoms of a blood clot in the brain or eyes); or sudden pain in the stomach or lumbar area (and that these could be symptoms of blood clots in the gut or kidneys). Advise patients to contact their healthcare provider for mild reactions and to seek urgent medical attention for moderate to severe reactions [see Warnings and Precautions (5.1)].

o

In conditions in which tissue factor is overexpressed (e.g., advanced atherosclerotic disease, crush injury, cancer, or septicemia), there may be a risk of thromboembolic events or disseminated intravascular coagulation (DIC) with Alhemo treatment.

•

Hypersensitivity: Inform patients of the early signs of hypersensitivity reactions, including rash, redness, hives, and itching, facial swelling, tightness of the chest, and wheezing as well the signs of an anaphylactic reaction such as itching on large areas of skin; redness and/or swelling of lips, tongue, face, or hands; difficulty swallowing; shortness of breath; wheezing; tightness of the chest; pale and cold skin; fast heartbeat; or dizziness/low blood pressure. Advise patients to discontinue use of Alhemo immediately and contact their healthcare provider if any signs or symptoms occur [see Warnings and Precautions (5.2)].

Advise patients on the importance of adherence to daily dosing and to speak with their healthcare provider before discontinuing treatment with Alhemo as patients who are not adhering to daily dosing or stop treatment with Alhemo may no longer be protected against bleeding.

Advise patients to follow the recommendations regarding proper sharps disposal provided in the FDA-approved Instructions for Use.

Patent Information: http://novonordisk-us.com/products/product-patents.html

Alhemo® is a registered trademark of Novo Nordisk Health Care AG.

NovoFine®, NovoFine® Plus, and Novo Nordisk® are registered trademarks of Novo Nordisk A/S.

For information about Alhemo contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-844-668-6732

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License No. 1261

At: Novo Nordisk A/S

Novo Allé 1

2880 Bagsvaerd

Denmark

© 2024 Novo Nordisk

MEDICATION GUIDE

Alhemo® (al-HEE-mo)

(concizumab-mtci)

injection, for subcutaneous use

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 12/2024

INSTRUCTIONS FOR USE
Alhemo® (al-HEE-mo)

(concizumab-mtci)

injection, for subcutaneous use

60 mg/1.5 mL (40 mg/mL) single-patient-use prefilled pen

This Instructions for Use contains information on how to inject Alhemo. Read and understand these instructions before you use the Alhemo pen. Make sure you have received training from your healthcare provider before you inject with this pen for the first time.

Gather the following supplies:

•

1 Alhemo pen

Supplies you will need that are not included in the carton:

•

a new needle for each injection.The Alhemo pen is recommended to be used with NovoFine® and NovoFine® Plus needles with a gauge of 32 and length of 4 mm (32G x 4 mm).

•

sharps disposal container. See “Throwing away (disposing of) Alhemo pens, needles and needle caps.”

•

alcohol swab

•

Take your dose as prescribed by your healthcare provider.

•

Alhemo is supplied as a prefilled pen (called “Alhemo pen” or “pen” in these instructions). It contains 60 milligrams (mg) of Alhemo for subcutaneous injection. The pen contains multiple doses of Alhemo.

•

The pen can deliver a maximum of 32 mg in 1 injection. The interval on the dose counter is 0.4 mg. If you need more than 32 mg, you need to inject multiple times. Your healthcare provider will tell you how much Alhemo to inject.

Where on my body should I inject my dose?

•

You can inject into the skin of:

o

your stomach-area (abdomen) at least 2 inches from your belly button (navel)

 

or

o

your upper legs (thigh).

•

The gray areas on the picture to the right show the injection sites.

•

Change (rotate) your injection site with each injection every day. Do not use the same site for each injection.

•

Do not inject into skin that is tender, bruised, red or hard, or areas where there are moles, scars, or stretch marks.

1. Check your Alhemo pen

•

Wash your hands with soap and water

 

Dry them well.

•

Check the pen label

 

Check the name, strength, and colored label to make sure you have the right medicine.

•

Check the expiration date

 

Check the expiration date (EXP) on the pen label to make sure it has not passed (YYYY-MM-DD). If the expiration date has passed, do not use the pen.

•

Inspect the medicine

 

Pull off the pen cap and check that Alhemo in the pen window is almost clear and colorless to slightly yellow. The medicine may contain particles that you can see-through or are white. Do not use the pen if the medicine is discolored.

•

If your pen is cold

 

You can inject Alhemo right from the refrigerator or let it reach room temperature before you inject. You can warm the pen in the palms of your hands. Do not use any other heating sources.

2. Attach a new needle

•

Take a new needle and tear off the paper tab.

•

Push the needle straight onto your pen. Turn the needle clockwise until it is on tight. See Figure A.

•

Pull off the outer needle cap. See Figure B.

•

Pull off the inner needle cap.See Figure B.

•

Throw the needle caps away in an FDA-cleared sharps disposal container.

Note: Always use a new needle for each injection.

3. Prime before each dose. Dial to ‘0.4’ and test the flow before each dose

•

A drop of Alhemo may appear at the needle tip, but you should still test the Alhemo flow before each injection to make sure you get the correct dose of Alhemo:

o

Turn the dose selector one marking to select 0.4 mg. See Figure C.

o

Press the dose button. See Figure D.

o

Watch a stream of Alhemo leaving the needle tip. See Figure D.

•

If no stream appears, go to “Troubleshooting if no stream appears when testing the flow.”

 

4. Select your dose

 

•

Turn the dose selector to select your prescribed dose.

•

You can adjust your dose by turning the dose selector in either direction (forwards or backwards).

•

If you need a larger dose than you can dial, you must inject yourself multiple times to get your full dose. For more information, see Step 6.

•

Each pen contains 60 mg of Alhemo.

•

The pen can deliver doses from 0.4 mg to 32 mg in 1 injection.

5a. Prepare the injection site

Read Steps 5a and 5b before you start injecting. This is to make sure you get your full dose.

•

Select the injection site. See “Where on my body should I inject my dose?”

•

Wipe the injection site with an alcohol swab and let the area dry. Do not touch the injection site after cleaning.

•

Insert the needle straight into your stomach-area (abdomen) or upper legs (thigh) at a 90-degree angle, as instructed by your healthcare provider.

5b. Inject Alhemo

•

Press and hold the dose button down until the dose counter returns to “0”.

•

After the dose counter has returned to “0”, count slowly to 6 while the needle is still in your skin.

•

Remove the needle from your skin.

The pen clicks during the injection and you might also hear or feel a click when the dose counter returns to “0”.

6. Remove the needle

•

Carefully remove the needle from your pen by turning the needle counterclockwise. Do not touch the pen needle on either side to avoid sticking yourself with the needle.

•

Place the needle in an FDA-cleared sharps disposal container right away to reduce the risk of a needle stick. See “Throwing away (disposing of) Alhemo pens, needles and needle caps.”

•

Do not put the needle cap back on.

Do you need a larger dose than you can dial?

Repeat Steps 1 to 6 until you have received your full dose. When you have received your full dose go to Step 7.

•

Use a new needle for each injection.

•

Test the Alhemo flow before each injection.

•

Make sure you know how much to inject in each injection to receive your full dose.

Note: Only split your dose if you have been trained or told by your healthcare provider on how to do this.

7. Recap the pen

•

Put the pen cap back on your pen to protect Alhemo from light.

•

Now your pen is ready for storage until you need it next time. See “Storing Alhemo.”

Important information you need to know before injecting Alhemo

•

Use Alhemo exactly as prescribed by your healthcare provider.

•

Your Alhemo pen is for single-patient-use only. Do not share your Alhemo pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

•

Your healthcare provider should show you or your caregiver how to use Alhemo before you use it for the first time.

•

Ask your healthcare provider if you need to use a different injection technique. For example, children and people who are lean may need to inject into a pinched fold of skin to avoid injecting too deep (into the muscle).

•

After 28 days, you must throw away (discard) your pen in an FDA-cleared sharps disposal container even if some medicine is left in the pen.

•

The pen can deliver doses from 0.4 mg to 32 mg in 1 injection. If your dose is more than 32 mg, you need to inject multiple times.

Important information about needles

•

Needles can be used for 1 injection only. Always use a new needle for each injection.

•

Do not reuse needles as this reduces the risk of contamination, infection, leakage, blocked needles, and incorrect dosing.

•

Never share needles with others.

•

Alhemo is recommended to be used with NovoFine and NovoFine Plus 32G x 4 mm injection needles.

•

If you use needles longer than 4 mm, talk to your healthcare provider about how to perform your injection.

•

Talk to your healthcare provider or pharmacist for more information about needles for your Alhemo pen.

•

Do not use the needle if it is bent or damaged.

Troubleshooting if no stream appears when testing the flow (Step 3)

•

If no stream appears, repeat Step 3 up to 6 times until you see a stream.

•

If still no stream appears, prepare a new needle (Step 2) and test again (Step 3).

•

If still no stream appears after attaching a new needle, do not use the pen. Use a new pen or call Novo Nordisk at 1-844-668-6732 for help.

How much Alhemo is left in your pen?

The pen scale shows about how much Alhemo is left in your pen. In the example below, 24 milligrams (mg) is remaining in the pen.

If you want to see more accurately how much Alhemo is left in your pen, turn the dose selector until it stops. The dose pointer will line up with the number of mg left in the pen.

If the dose counter shows 32 mg, at least 32 mg is left in the pen. If the dose counter shows less than 32 mg, the number shown in the dose counter is the number of mg left in your pen. In the example below, the dose counter shows 13.6 mg, so there is 13.6 mg of Alhemo left in the pen.

Storing Alhemo

•

Before first use:

o

Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C).

•

After first use:

o

Store the Alhemo pen in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature no warmer than 86°F (30°C) for up to 28 days.

o

Write the date of first use in the space provided on the carton.

o

Throw away (discard) the Alhemo pen 28 days after first opening even if some medicine is left in the pen.

•

Store Alhemo with the cap on and keep it in the original carton to protect from light.

•

Do not store Alhemo in direct sunlight and keep away from direct heat.

•

When stored in the refrigerator, do not store the pen directly next to the cooling element (the part that cools the refrigerator).

•

Do not freeze Alhemo.

•

Do not use Alhemo if it has been frozen or if it has been stored above 86°F (30°C).

Keep Alhemo and all medicine out of the reach of children.

Throwing away (disposing of) Alhemo pens, needles and needle caps

•

Put your used pens, needles, and needle caps in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and pens in your household trash.

•

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

o

made of heavy-duty plastic,

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o

upright and stable during use,

o

leak-resistant, and

o

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 dispose of used needles and pens. For more information about safe sharps disposal, and for specific information about safe 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.

Scan the QR code below to access the Instructions for Use or visit: www.Alhemopen.com

Patent Information: http://novonordisk-us.com/products/product-patents.html

Alhemo® is a registered trademark of Novo Nordisk Health Care AG.

NovoFine®, NovoFine® Plus, and Novo Nordisk® are registered trademarks of Novo Nordisk A/S.

© 2024 Novo Nordisk Health Care AG

For further information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

1-844-668-6732

Manufactured by: Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License No. 1261

At: Novo Nordisk A/S

Novo Allé 1

2880 Bagsværd

Denmark

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

Issued: 12/2024

INSTRUCTIONS FOR USE

Alhemo® (al-HEE-mo)

(concizumab-mtci)

injection, for subcutaneous use

150 mg/1.5 mL (100 mg/mL) single-patient-use prefilled pen

This Instructions for Use contains information on how to inject Alhemo. Read and understand these instructions before you use the Alhemo pen. Make sure you have received training from your healthcare provider before you inject with this pen for the first time.

Gather the following supplies:

•

1 Alhemo pen

Supplies you will need that are not included in the carton:

•

a new needle for each injection. The Alhemo pen is recommended to be used with NovoFine® and NovoFine® Plus needles with a gauge of 32 and length of 4mm (32G x 4 mm).

•

sharps disposal container. See “Throwing away (disposing of) Alhemo pens, needles and needle caps.”

•

alcohol swab.

•

Take your dose as prescribed by your healthcare provider.

•

Alhemo is supplied as a prefilled pen (called “Alhemo pen” or “pen” in these instructions). It contains 150 milligrams (mg) of Alhemo for subcutaneous injection. The pen contains multiple doses of Alhemo.

•

The pen can deliver a maximum of 80 mg in 1 injection. The interval on the dose counter is 1 mg. If you need more than 80 mg, you need to inject multiple times. Your healthcare provider will tell you how much Alhemo to inject.

Where on my body should I inject my dose?

•

You can inject into the skin of:

o

your stomach-area (abdomen) at least 2 inches from your belly button (navel)

 

or

o

your upper legs (thigh).

•

The gray areas on the picture to the right show the injection sites.

•

Change (rotate) your injection site with each injection every day. Do not use the same site for each injection.

•

Do not inject into skin that is tender, bruised, red or hard, or areas where there are moles, scars, or stretch marks.

1. Check your Alhemo pen

•

Wash your hands with soap and water

 

Dry them well.

•

Check the pen label

 

Check the name, strength and, colored label to make sure you have the right medicine.

•

Check the expiration date

 

Check the expiration date (EXP) on the pen label to make sure it has not passed (YYYY-MM-DD). If the expiration date has passed, do not use the pen.

•

Inspect the medicine

 

Pull off the pen cap and check that Alhemo in the pen window is almost clear and colorless to slightly yellow. The medicine may contain particles that you can see-through or are white. Do not use the pen if the medicine is discolored.

•

If your pen is cold

 

You can inject Alhemo right from the refrigerator or let it reach room temperature before you inject. You can warm the pen in the palms of your hands. Do not use any other heating sources.

2. Attach a new needle

•

Take a new needle and tear off the paper tab.

•

Push the needle straight onto your pen. Turn the needle clockwise until it is

 

on tight. See Figure A.

•

Pull off the outer needle cap. See Figure B.

•

Pull off the inner needle cap.See Figure B.

•

Throw the needle caps away in an FDA-cleared sharps disposal container.

Note: Always use a new needle for each injection.

3. Prime before each dose. Dial to ‘1’ and test the flow before each dose

•

A drop of Alhemo may appear at the needle tip, but you should still test the Alhemo flow before each injection to make sure you get the correct dose of Alhemo:

o

Turn the dose selector one marking to select 1 mg. See Figure C.

o

Press the dose button. See Figure D.

o

Watch a stream of Alhemo leaving the needle tip. See Figure D.

•

If no stream appears, go to “Troubleshooting if no stream appears when testing the flow.”

4. Select your dose

•

Turn the dose selector to select your prescribed dose.

•

You can adjust your dose by turning the dose selector in either direction (forwards or backwards).

•

If you need a larger dose than you can dial, you must inject yourself multiple times to get your full dose. For more information, see Step 6.

•

Each pen contains 150 mg of Alhemo.

•

The pen can deliver doses from 1 mg to 80 mg in 1 injection.

5a. Prepare injection site

Read through Steps 5a and 5b before you start injecting. This is to make sure you get your full dose.

•

Select the injection site. See “Where on my body should I inject my dose?”

•

Wipe the injection site with an alcohol swab and let the area dry. Do not touch the injection site after cleaning.

•

Insert the needle straight into your stomach-area (abdomen) or upper legs (thigh) at a 90-degree angle, as instructed by your healthcare provider.

5b. Inject Alhemo

•

Press and hold the dose button down until the dose counter returns to “0”.

•

After the dose counter has returned to “0”, count slowly to 6 while the needle is still in your skin.

 

•

Remove the needle from your skin.

The pen clicks during the injection and you might also hear or feel a click when the dose counter returns to “0”.

6. Remove the needle

•

Carefully remove the needle from your pen by turning the needle counterclockwise. Do not touch the pen needle on either side to avoid sticking yourself with the needle.

•

Place the needle in an FDA-cleared sharps disposal container right away to reduce the risk of a needle stick. See “Throwing away (disposing of) Alhemo pens, needles and needle caps.”

•

Do not put the needle cap back on.

 

Do you need a larger dose than you can dial?

Repeat Steps 1 to 6 until you have received your full dose. When you have received your full dose go to Step 7.

•

Use a new needle for each injection.

•

Test the Alhemo flow before each injection.

•

Make sure you know how much to inject in each injection to receive your full dose.

 

Note: Only split your dose if you have been trained or told by your healthcare provider on how to do this.

7. Recap the pen

•

Put the pen cap back on your pen to protect Alhemo from light.

•

Now your pen is ready for storage until you need it next time. See “Storing Alhemo.”

Important information you need to know before injecting Alhemo

•

Use Alhemo exactly as prescribed by your healthcare provider.

•

Your Alhemo pen is for single-patient-use only. Do not share your Alhemo pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

•

Your healthcare provider should show you or your caregiver how to use Alhemo before you use it for the first time.

•

Ask your healthcare provider if you need to use a different injection technique. For example, children and people who are lean may need to inject into a pinched fold of skin to avoid injecting too deep (into the muscle).

•

After 28 days, you must throw away (discard) your pen in an FDA-cleared sharps disposal container even if some medicine is left in the pen.

•

The pen can deliver doses from 1 mg to 80 mg in 1 injection. If your dose is more than 80 mg, you need to inject multiple times.

Important information about needles

•

Needles can be used for 1 injection only. Always use a new needle for each injection.

•

Do not reuse needles as this reduces the risk of contamination, infection, leakage, blocked needles, and incorrect dosing.

•

Never share needles with others.

•

Alhemo is recommended to be used with NovoFine and NovoFine Plus 32G x 4 mm injection needles.

•

If you use needles longer than 4 mm, talk to your healthcare provider about how to perform your injection.

•

Talk to your healthcare provider or pharmacist for more information about needles for your Alhemo pen.

•

Do not use the needle if it is bent or damaged.

Troubleshooting if no stream appears when testing the flow (Step 3)

•

If no stream appears, repeat Step 3 up to 6 times until you see a stream.

•

If still no stream appears, prepare a new needle (Step 2) and test again (Step 3).

•

If still no stream appears after attaching a new needle, do not use the pen. Use a new pen or call Novo Nordisk at 1-844-668-6732 for help.

How much Alhemo is left in your pen?

The pen scale shows about how much Alhemo is left in your pen. In the example below, 60 milligrams (mg) is remaining in the pen.

If you want to see more accurately how much Alhemo is left in your pen, turn the dose selector until it stops. The dose pointer will line up with the number of mg left in the pen.

If the dose counter shows 80 mg, at least 80 mg is left in the pen. If the dose counter shows less than 80 mg, the number shown in the dose counter is the number of mg left in your pen. In the example below, the dose counter shows 34 mg, so there is 34 mg of Alhemo left in the pen.

Storing Alhemo

•

Before first use:

o

Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C).

•

After first use:

o

Store the Alhemo pen in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature no warmer than 86°F (30°C) for up to 28 days.

o

Write the date of first use in the space provided on the carton.

o

Throw away (discard) the Alhemo pen 28 days after first opening even if some medicine is left in the pen.

•

Store Alhemo with the cap on and keep it in the original carton to protect from light.

•

Do not store Alhemo in direct sunlight and keep away from direct heat.

•

When stored in the refrigerator, do not store the pen directly next to the cooling element (the part that cools the refrigerator).

•

Do not freeze Alhemo.

•

Do not use Alhemo if it has been frozen or if it has been stored above 86°F (30°C).

Keep Alhemo and all medicine out of the reach of children.

Throwing away (disposing of) Alhemo pens, needles, needle caps

•

Put your used pens, needles, and needle caps in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and pens in your household trash.

•

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

o

made of heavy-duty plastic,

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o

upright and stable during use,

o

leak-resistant, and

o

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 dispose of used needles and pens. For more information about safe sharps disposal, and for specific information about safe 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.

Scan the QR code below to access the Instructions for Use or visit: www.Alhemopen.com

Patent Information: http://novonordisk-us.com/products/product-patents.html

Alhemo® is a registered trademark of Novo Nordisk Health Care AG.

NovoFine®, NovoFine® Plus, and Novo Nordisk® are registered trademarks of Novo Nordisk A/S.

© 2024 Novo Nordisk Health Care AG

For further information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

1-844-668-6732

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License No. 1261

At: Novo Nordisk A/S

Novo Allé 1

2880 Bagsvaerd

Denmark

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

Issued: 12/2024

INSTRUCTIONS FOR USE

Alhemo® (al-HEE-mo)

(concizumab-mtci)

injection, for subcutaneous use

300 mg/3 mL (100 mg/mL) single-patient-use prefilled pen

This Instructions for Use contains information on how to inject Alhemo. Read and understand these instructions before you use the Alhemo pen. Make sure you have received training from your healthcare provider before you inject with this pen for the first time.

Gather the following supplies:

•

1 Alhemo pen

Supplies you will need that are not included in the carton:

•

a new needle for each injection. The Alhemo pen is recommended to be used with NovoFine® and NovoFine® Plus needles with a gauge of 32 and length of 4mm (32G x 4 mm).

•

sharps disposal container. See “Throwing away (disposing of) Alhemo pens, needles and needle caps.”

•

alcohol swab

•

Take your dose as prescribed by your healthcare provider.

•

Alhemo is supplied as a prefilled pen (called “Alhemo pen” or “pen” in these instructions). It contains 300 milligrams (mg) of Alhemo for subcutaneous injection. The pen contains multiple doses of Alhemo.

•

The pen can deliver a maximum of 80 mg in 1 injection. The interval on the dose counter is 1 mg. If you need more than 80 mg, you need to inject multiple times. Your healthcare provider will tell you how much Alhemo to inject.

Where on my body should I inject my dose?

•

You can inject into the skin of:

o

your stomach-area (abdomen) at least 2 inches from your belly button (navel)

 

or

o

your upper legs (thigh).

•

The gray areas on the picture to the right show the injection sites.

•

Change (rotate) your injection site with each injection every day. Do not use the same site for each injection.

•

Do not inject into skin that is tender, bruised, red or hard, or areas where there are moles, scars, or stretch marks.

1. Check your Alhemo pen

•

Wash your hands with soap and water

 

Dry them well.

•

Check the pen label

 

Check the name, strength, and colored label to make sure you have the right medicine.

•

Check the expiration date

 

Check the expiration date (EXP) on the pen label to make sure it has not passed (YYYY-MM-DD). If the expiration date has passed, do not use the pen.

•

Inspect the medicine

 

Pull off the pen cap and check that Alhemo in the pen window is almost clear and colorless to slightly yellow. The medicine may contain particles that you can see-through or are white. Do not use the pen if the medicine is discolored.

•

If your pen is cold

 

You can inject Alhemo right from the refrigerator or let it reach room temperature before you inject. You can warm the pen in the palms of your hands. Do not use any other heating sources.

2. Attach a new needle

•

Take a new needle and tear off the paper tab.

•

Push the needle straight onto your pen. Turn the needle clockwise until it is

 

on tight. See Figure A.

•

Pull off the outer needle cap. See Figure B.

•

Pull off the inner needle cap.See Figure B.

•

Throw the needle caps away in an FDA-cleared sharps disposal container.

Note: Always use a new needle for each injection.

3. Prime before each dose. Dial to ‘1’ and test the flow before each dose

•

A drop of Alhemo may appear at the needle tip, but you should still test the Alhemo flow before each injection to make sure you get the correct dose of Alhemo:

o

Turn the dose selector one marking to select 1 mg. See Figure C.

o

Press the dose button. See Figure D.

o

Watch a stream of Alhemo leaving the needle tip. See Figure D.

•

If no stream appears, go to “Troubleshooting if no stream appears when testing the flow.”

4. Select your dose

•

Turn the dose selector to select your prescribed dose.

•

You can adjust your dose by turning the dose selector in either direction (forwards or backwards).

•

If you need a larger dose than you can dial, you must inject yourself multiple times to get your full dose. For more information, see Step 6.

•

Each pen contains 300 mg of Alhemo.

•

The pen can deliver doses from 1 mg to 80 mg in 1 injection.

5a. Prepare the injection site

Read through Steps 5a and 5b before you start injecting. This is to make sure you get your full dose.

•

Select the injection site. See “Where on my body should I inject my dose?”

•

Wipe the injection site with an alcohol swab and let the area dry. Do not touch the injection site after cleaning.

•

Insert the needle straight into your stomach-area (abdomen) or upper legs (thigh) at a 90-degree angle, as instructed by your healthcare provider.

5b. Inject Alhemo

•

Press and hold the dose button down until the dose counter returns to “0”.

•

Once the dose counter has returned to “0”, count slowly to 6 while the needle is still in your skin.

•

Remove the needle from your skin.

The pen clicks during the injection and you might also hear or feel a click when the dose counter returns to “0”.

6. Remove the needle

•

Carefully remove the needle from your pen by turning the needle counterclockwise. Do not touch the pen needle on either side to avoid sticking yourself with the needle.

•

Place the needle in an FDA-cleared sharps disposal container right away to reduce the risk of a needle stick. See “Throwing away (disposing of) Alhemo pens, needles and needle caps.”

•

Do not put the needle cap back on.

 

Do you need a larger dose than you can dial?

Repeat Steps 1 to 6 until you have received your full dose. When you have received your full dose go to Step 7.

•

Use a new needle for each injection.

•

Test the Alhemo flow before each injection.

•

Make sure you know how much to inject in each injection to receive your full dose.

 

Note: Only split your dose if you have been trained or told by your healthcare provider on how to do this.

7. Recap the pen

•

Put the pen cap back on your pen to protect Alhemo from light.

•

Now your pen is ready for storage until you need it next time. See “Storing Alhemo.”

Important information you need to know before injecting Alhemo

•

Use Alhemo exactly as prescribed by your healthcare provider.

•

Your Alhemo pen is for single-patient-use only. Do not share your Alhemo pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

•

Your healthcare provider should show you or your caregiver how to use Alhemo before you use it for the first time.

•

Ask your healthcare provider if you need to use a different injection technique. For example, children and people who are lean may need to inject into a pinched fold of skin to avoid injecting too deep (into the muscle).

•

After 28 days, you must throw away (discard) your pen in an FDA-cleared sharps disposal container even if some medicine is left in the pen.

•

The pen can deliver doses from 1 mg to 80 mg in 1 injection. If your dose is more than 80 mg, you need to inject multiple times.

Important information about needles

•

Needles can be used for 1 injection only. Always use a new needle for each injection.

•

Do not reuse needles as this reduces the risk of contamination, infection, leakage, blocked needles, and incorrect dosing.

•

Never share needles with others.

•

Alhemo is recommended to be used with NovoFine and NovoFine Plus 32G x 4 mm injection needles.

•

If you use needles longer than 4 mm, talk to your healthcare provider about how to perform your injection.

•

Talk to your healthcare provider or pharmacist for more information about needles for your Alhemo pen.

•

Do not use the needle if it is bent or damaged.

Troubleshooting if no stream appears when testing the flow (Step 3)

•

If no stream appears, repeat Step 3 up to 6 times until you see a stream.

•

If still no stream appears, prepare a new needle (Step 2) and test again (Step 3).

•

If still no stream appears after attaching a new needle, do not use the pen. Use a new pen or call Novo Nordisk at 1-844-668-6732 for help.

How much Alhemo is left in your pen?

The pen scale shows about how much Alhemo is left in your pen. In the example below, 200 milligrams (mg) is remaining in the pen.

If you want to see more accurately how much Alhemo is left in your pen, turn the dose selector until it stops. The dose pointer will line up with the number of mg left in the pen.

If the dose counter shows 80 mg, at least 80 mg is left in the pen. If the dose counter shows less than 80 mg, the number shown in the dose counter is the number of mg left in the pen. In the example below, the dose counter shows 34 mg, so there is 34 mg of Alhemo left in the pen.

Storing Alhemo

•

Before first use:

o

Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C).

•

After first use:

o

Store the Alhemo pen in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature no warmer than 86°F (30°C) for up to 28 days.

o

Write the date of first use in the space provided on the carton.

o

Throw away (discard) the Alhemo pen 28 days after first opening even if some medicine is left in the pen.

•

Store Alhemo with the cap on and keep it in the original carton to protect from light.

•

Do not store Alhemo in direct sunlight and keep away from direct heat.

•

When stored in the refrigerator, do not store the pen directly next to the cooling element (the part that cools the refrigerator).

•

Do not freeze Alhemo.

•

Do not use Alhemo if it has been frozen or if it has been stored above 86°F (30°C).

Keep Alhemo and all medicine out of the reach of children.

Throwing away (disposing of) Alhemo pens, needles, needle caps

•

Put your used pens, needles, and needle caps in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and pens in your household trash.

•

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

o

made of heavy-duty plastic,

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o

upright and stable during use,

o

leak-resistant, and

o

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 dispose of used needles and pens. For more information about safe sharps disposal, and for specific information about safe 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.

Scan the QR code below to access the Instructions for Use or visit: www.Alhemopen.com

Patent Information: http://novonordisk-us.com/products/product-patents.html

Alhemo® is a registered trademark of Novo Nordisk Health Care AG.

NovoFine®, NovoFine® Plus, and Novo Nordisk® are registered trademarks of Novo Nordisk A/S.

© 2024 Novo Nordisk Health Care AG

For further information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

1-844-668-6732

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License No. 1261

At: Novo Nordisk A/S

Novo Allé 1

2880 Bagsvaerd

Denmark

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

Issued: 12/2024

 

NDC 0169-2084-15 List: 208415

 

Alhemo®

 

(concizumab-mtci) injection

60 mg/1.5 mL (40 mg/mL)

For subcutaneous use only

1x1.5 mL single-patient use prefilled pen

Dials in 0.4 mg increments and contains

60 mg total

Rx only

ATTENTION: Dispense the enclosed Medication Guide to each patient.

 

NDC 0169-2080-15 List: 208015

 

Alhemo®

 

(concizumab-mtci) injection

150 mg/1.5 mL (100 mg/mL)

For subcutaneous use only

1x1.5 mL single-patient use prefilled pen

Dials in 1 mg increments and contains 150 mg total

Rx only

ATTENTION: Dispense the enclosed Medication Guide to each patient.

 

NDC 0169-2081-03 List : 208103

 

Alhemo®

 

(concizumab-mtci) injection

300 mg/3 mL (100 mg/mL)

Prefilled Pen

For subcutaneous use only

1x3 mL single-patient use prefilled pen

Dials in 1 mg increments and contains

300 mg total

Rx only

ATTENTION: Dispense the enclosed Medication Guide to each patient.