Patient information: uses, side effects, how to take - Alhemo

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

It is important to follow the daily dosing schedule of Alhemo to stay protected against bleeding. This is especially important during the first 4 weeks of treatment to make sure a correct maintenance dose is established.Use Alhemo exactly as prescribed by your healthcare provider. Do not stop using Alhemo without talking to your healthcare provider. If you miss doses, or stop using Alhemo, you may no longer be protected against bleeding.
Your healthcare provider may prescribe factor VIII, factor IX or bypassing agents during treatment with Alhemo. Carefully follow your healthcare provider’s instructions regarding when to use on-demand factor VIII, factor IX or bypassing agents, and the recommended dose and schedule for breakthrough bleeds.

See “How should I use Alhemo?” for more information on how to use Alhemo.

What is Alhemo?

Alhemo is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with:

hemophilia A with or without factor VIII inhibitors
hemophilia B with or without factor IX inhibitors

It is not known if Alhemo is safe and effective in people while receiving ongoing Immune Tolerance Induction (ITI).

It is not known if Alhemo is safe and effective for hemophilia A and B with and without inhibitors in children younger than 12 years of age.

Do not use Alhemo if you are allergic to concizumab-mtci or any of the ingredients in Alhemo. See the end of this Medication Guide for a complete list of ingredients in Alhemo.

Before using Alhemo, tell your healthcare provider about all of your medical conditions, including if you:

have a planned surgery. Your healthcare provider may stop treatment with Alhemo before your surgery. Talk to your healthcare provider about when to stop using Alhemo and when to start it again if you have a planned surgery.
are pregnant or plan to become pregnant. It is not known if Alhemo may harm your unborn baby.
Females who are able to become pregnant:
Your healthcare provider may do a pregnancy test before you start treatment with Alhemo.
You should use an effective birth control (contraception) during treatment with Alhemo and for 7 weeks after ending treatment. Talk to your healthcare provider about birth control methods that you can use during this time.
are breastfeeding or plan to breastfeed. It is not known if Alhemo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Alhemo.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Alhemo?

Read the Instructions for Use that comes with Alhemo for information about how to prepare and inject a dose of Alhemo, and how to properly throw away (dispose of) used Alhemo pens and needles.

Use Alhemo exactly as prescribed by your healthcare provider.
Your healthcare provider will provide instructions for stopping (discontinuing) your current treatment when switching to Alhemo.
Inject Alhemo 1 time a day.
Your healthcare provider should show you or your caregiver how to use Alhemo before you use it for the first time.
Alhemo is given as an injection under the skin (subcutaneous injection) by you or a caregiver.
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).
Change (rotate) your injection site with each injection. Do not use the same site for each injection.
You will inject a larger dose (a loading dose) of Alhemo on your first day of treatment. Then your healthcare provider will prescribe a dose to inject 1 time a day until your maintenance dose is established.
To determine the right maintenance dose for you, your healthcare provider will do a blood test to check the amount of Alhemo in your blood. Your healthcare provider may do additional blood tests during treatment with Alhemo.
Your healthcare provider will prescribe your dose based on your weight. If your weight changes, tell your healthcare provider.
Your healthcare provider will provide information on the treatment of breakthrough bleeding during your treatment with Alhemo.
Do not share your Alhemo pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them.
If you miss a dose of Alhemo during the first 4 weeks of treatment, contact your healthcare provider right away. Your healthcare provider will tell you how much Alhemo to inject.
If you miss a dose of Alhemo after your daily maintenance dose is established:
For 1 missed dose, continue your daily maintenance dose.
For 2 to 6 missed doses, give 2 doses as soon as you remember. Then continue your daily maintenance dose the next day.

For 7 or more missed doses, contact your healthcare provider right away as you will need to receive a new loading dose before continuing your daily maintenance dose.
If you are unsure about how much Alhemo to inject, contact your healthcare provider.

What are the possible side effects of Alhemo?

Alhemo may cause serious side effects, including:

Blood clots (thromboembolic events). Alhemo may cause blood clots to form in blood vessels, such as in your arms, legs, heart, lung, brain, eyes, kidneys, or stomach. You may be at risk for getting blood clots during treatment with Alhemo if you use high or frequent doses of factor products or bypassing agents to treat breakthrough bleeds, or if you have certain conditions.Get medical help right away if you have any signs and symptoms of blood clots, including:

swelling, warmth, pain, or redness of the skin

feeling short of breath or severe chest pain

headache

confusion

trouble speaking or moving

numbness in your face

eye pain or swelling

problems with your vision

sudden pain in your stomach or lower back area

Allergic reactions. Alhemo can cause allergic reactions, including reactions that can be serious. Stop using Alhemo and tell your healthcare provider right away if you have redness of the skin, rash, hives, itching, and stomach-area (abdominal) pain. Stop using Alhemo and get emergency medical help right away if you develop any signs or symptoms of a severe allergic reaction, including:

itching on large areas of skin

redness or swelling of lips, tongue, face, or hands

trouble swallowing

shortness of breath

wheezing

tightness of the chest

pale and cold skin

fast heartbeat

dizziness due to low blood pressure

The most common side effects of Alhemo include:

bruising, redness, bleeding, itching, rash, or lump at the injection site

hives
headache

These are not all the possible side effects of Alhemo.

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

How should I store Alhemo?

Before first use:
Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
After first use:
Store the Alhemo pen in the refrigerator between 36°F to 46°F (2°C 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.
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.

General information about the safe and effective use of Alhemo.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Alhemo for a condition for which it was not prescribed. Do not give Alhemo to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Alhemo that is written for health professionals.

What are the ingredients in Alhemo?

Active ingredient: concizumab-mtci

Inactive ingredients: arginine hydrochloride, histidine, phenol, polysorbate 80, sodium chloride, sucrose, and water for injection. Hydrochloric acid and sodium hydroxide may be added for pH adjustment.

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

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

For information about Alhemo contact: Novo Nordisk Inc., 800 Scudders Mill Road Plainsboro, NJ 08536.

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

For more information, go to Alhemo.com or call 1-844-668-6732.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised:07/2025

Instructions for Use – 1.5 mL (60 mg)

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.

Important information you need to know before injecting Alhemo

Use Alhemo exactly 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.
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 one 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.

Important information about needles

Needles can be used for 1 injection only. Always use a new needle for each injection.
Do not re-use 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.

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

Where on my body should I inject my dose?

You can inject into the skin of:
your stomach-area (abdomen) at least 2 inches from your belly button (navel)
or
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 to the right (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 a 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:
Turn the dose selector one marking to select 0.4 mg. See Figure C.
Press the dose button. See Figure D.
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 one 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 to the left (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.”

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:
Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
After first use:
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.
Write the date of first use in the space provided on the carton.
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:
made of 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 labelled 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.Alhemo.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.

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.

Revised: 07/2025