Pronunciation: al-HEE-mo
Generic name: concizumab-mtci
Dosage form: single-use prefilled pen injection for subcutaneous use (60 mg/1.5 mL, 150 mg/1.5 mL, 300 mg/3 mL)
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 23, 2024.

What is Alhemo?

Alhemo is used daily to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors.

• It is not known if Alhemo (generic name concizumab-mtci) is safe and effective in people using Alhemo while receiving ongoing Immune Tolerance Induction (ITI).

Alhemo’s mechanism of action involves blocking a protein called Tissue Factor Pathway Inhibitor (TFPI) that normally slows down blood clotting. By blocking this protein, Alhemo helps blood clot more effectively. Since Alhemo works differently from standard hemophilia treatments, it still works even when patients have developed antibodies against those treatments. Also, because it's very structurally different from standard treatments, it won't cause patients to develop new antibodies.

Alhemo gained FDA approval on December 20, 2024. There is no Alhemo generic.

Alhemo side effects

The most common side effects of Alhemo are:

• bruising, redness, bleeding, or itching at the site of injection
• hives.

Serious side effects and warnings

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 a dose or doses, or stop using Alhemo, you may no longer be protected against bleeding.

Your healthcare provider may prescribe bypassing agents during treatment with Alhemo. Carefully follow your healthcare provider’s instructions regarding when to use on-demand bypassing agents and the recommended dose and schedule for breakthrough bleeds.

Alhemo may cause the following serious side effects.

Blood clots (thromboembolic events). Alhemo may cause blood clots to form in blood vessels, such as in your arms, legs, heart, lungs, 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
• headache
• trouble speaking or moving
• eye pain or swelling
• sudden pain in your stomach or lower back area
• feeling short of breath or severe chest pain
• confusion
• numbness in your face
• problems with your vision.

Allergic reactions. Alhemo can cause allergic reactions, including 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
• trouble swallowing
• wheezing
• pale and cold skin
• dizziness due to low blood pressure
• redness or swelling of lips, tongue, face, or hands
• shortness of breath
• tightness of the chest
• fast heartbeat.

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.

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 the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

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

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
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Alhemo may harm your unborn baby. Females who can become pregnant:

• your healthcare provider may do a pregnancy test before you start treatment with Alhemo
• you should use 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.

Breastfeeding

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.

How should I use Alhemo?

Read the Instructions for Use that comes with Alhemo Package Insert for information about how to prepare and inject a dose, 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.

Alhemo dosing information

Administer Alhemo by subcutaneous injection to the abdomen or thigh with daily rotation of injection sites.

Recommended dosing regimen:

• Day 1: Loading dose of Alhemo 1 mg/kg
• Day 2: Once-daily dose of Alhemo 0.2 mg/kg until individualization of maintenance dose (see below)
• 4 weeks after initiation of treatment: For dose optimization, measure concizumab-mtci plasma concentration by Concizumab Enzyme-Linked Immunosorbent Assay (ELISA) prior to administration of the next scheduled dose.
  • An FDA-authorized test for the measurement of concizumab-mtci concentration in plasma is not currently available.

Once the concizumab-mtci concentration result is available, individualize the maintenance dose of Alhemo no later than 8 weeks after initiation of treatment, based on the following concizumab-mtci plasma concentrations:

• Less than 200 ng/mL: adjust to a once-daily dose of 0.25 mg/kg
• 200 to 4,000 ng/mL: continue once-daily dose of 0.2 mg/kg
• Greater than 4,000 ng/mL: adjust to a once-daily dose of 0.15 mg/kg

See the Alhemo Prescribing Information for full dosing instructions.

What happens if I miss a dose of Alhemo?

Follow the instructions below if you miss a dose of Alhemo after your daily maintenance dose is established:

• For 1 missed dose, continue your normal daily dose
• For 2 to 6 missed doses, give 2 doses as soon as you remember. Then continue your normal daily 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 normal daily dose.

If you are unsure about how much Alhemo to inject, contact your healthcare provider.

What other drugs will affect 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.

Clotting medications (like rFVIIa or aPCC) may still be used to treat unexpected bleeding while using Alhemo. However, using high doses of these medications, or using them often, while on Alhemo increases the risk of developing blood clots.

This is not a full list of drug interactions. See the Alhemo Prescribing Information for a complete list.

Alhemo storage

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° 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 it 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.

Alhemo ingredients

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.

Alhemo is available in the following dosages as a single-patient-use prefilled pen

• 60 mg/1.5 mL (40 mg/mL)
• 150 mg/1.5 mL (100 mg/mL)
• 300 mg/3 mL (100 mg/mL).

Who makes Alhemo?

Novo Nordisk Inc. makes Alhemo.

Alhemo Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Alhemo.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer