Powerful bleed protection

Royal lives with hemophilia B with inhibitors, uses Alhemo®, and is an employee of Novo Nordisk.

Alhemo® offers bleed prevention with proven results

Results from a clinical trial with people who have hemophilia B with inhibitors or hemophilia A with inhibitors

Primary study results:

Treated spontaneous and traumatic bleeds

Clinical trial results charts
Clinical trial results charts

Study design

Clinical study of Alhemo® included people ages 12 years and older who had hemophilia A with inhibitors (80 people) and hemophilia B with inhibitors (53 people) who were treated with either bypassing agents on demand (at least 24 weeks) or Alhemo® once-daily prophylaxis (at least 32 weeks).

Discover lower target joint bleed rate and more bleed-free patients

88

%

lower target joint bleed ratea

Supportive secondary study result. Average target joint annual bleed rate of 0.1 with Alhemo® (33 people) vs 1.1 with no prophylaxis (19 people)

64

%

had zero bleedsb

in 24 weeks for people on Alhemo® prophylaxis (21 people) vs 10.5% for no prophylaxis (2 people)

 

Additional assessment study result

aTreated target joint bleeds. 

bPatients with zero treated bleeds within first 24 weeks.

I can’t remember the last time I had a bleed.

–Royal

Individual results may vary. It is important to follow the daily dosing schedule of Alhemo® to stay protected against bleeding.

Royal lives with hemophilia B with inhibitors, uses Alhemo®, and is an employee of Novo Nordisk.

Jericho lives with hemophilia A with inhibitors and uses Alhemo®

Safety confirmed in multiple clinical trials

people in clinical trials,

including 133 males with hemophilia with inhibitors

320 males with hemophilia A with and without inhibitors and hemophilia B with and without inhibitors received at least one dose of Alhemo® as routine prophylaxis. 52 people with inhibitors were previously treated with on demand therapy and were randomized to receive on demand treatment with bypassing agents (19 people) or Alhemo® prophylaxis (33 people).

thromboembolic events

in the clinical trial of people with hemophilia with inhibitors, after trial restarta

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; 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; and problems with your vision.

routine liver monitoring required

boxed warning

aThe explorer7 and explorer8 clinical trials were temporarily paused because 3 patients experienced 5 nonfatal TEs. In response, a plan was put in place that included deploying a laboratory developed test to measure concizumab-mtci levels in order to individualize dosing, as well as guidance around how to treat breakthrough bleeds.

Jericho lives with hemophilia A with inhibitors and uses Alhemo®

Breakthrough bleed icon

All bypassing agents can be used to treat breakthrough bleeds

Alhemo® does not treat bleeds. Your healthcare provider may prescribe a bypassing agent to use if you experience a breakthrough bleed. Follow your healthcare provider’s instructions regarding when to use on-demand bypassing agents and the recommended dose and schedule for breakthrough bleeds.

In the randomized arms of the clinical trial of people with inhibitors, injection site reactions were the most common adverse reactions, reported in 6 out of 33 people (18%) using Alhemo®, followed by hives, reported in 2 out of 33 people (6%).

 

Majority of injection site reactions were mild.

 

An allergic reaction in 1 patient (3%) led to stopping Alhemo® treatment.

Dosing and administration

Discover Alhemo®’s personalized dosing and administration steps.

Learn more

Connect with us!

Want to learn more about Alhemo®? Get important email updates, information about patient support programs, and more.

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Important Safety Information

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 (HCP). Do not stop using Alhemo® without talking to your HCP. If you miss doses or stop using Alhemo®, you may no longer be protected against bleeding
  • Your HCP may prescribe bypassing agents during treatment with Alhemo®. Carefully follow your HCP’s instructions regarding when to use on-demand bypassing agents, and the recommended dose and schedule for breakthrough bleeds

Do not use Alhemo® if you are allergic to concizumab-mtci or any of the ingredients in Alhemo®.

Before using Alhemo®, tell your HCP about all of your medical conditions, including if you:

  • Have a planned surgery. Talk to your HCP about when to stop using Alhemo® and when to start it again if you have a planned surgery
  • Are pregnant, breastfeeding, or plan to become pregnant or to breastfeed. It is not known if Alhemo® may harm your unborn baby or if Alhemo® passes into your breast milk
    • Your HCP may do a pregnancy test before you start treatment with Alhemo®.
    • Females who are able to become pregnant, talk to your HCP about using effective birth control (contraception) methods during treatment with Alhemo® and for 7 weeks after ending treatment

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and supplements.

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 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; and 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; and fast heartbeat

The most common side effects of Alhemo® include: bruising, redness, bleeding, or itching at the site of injection, and hives. These are not all the possible side effects of Alhemo. Call your doctor for medical advice about side effects.

Please see Prescribing Information and Medication Guide for Alhemo®.

Alhemo® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is Alhemo®?

Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg 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 factor VIII inhibitors or hemophilia B with factor IX inhibitors.

  • It is not known if Alhemo® is safe and effective in people receiving ongoing immune tolerance induction (ITI) or in children younger than 12 years of age

What is Alhemo®?

Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg 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 factor VIII inhibitors or hemophilia B with factor IX inhibitors.

  • It is not known if Alhemo® is safe and effective in people receiving ongoing immune tolerance induction (ITI) or in children younger than 12 years of age

Show more Show less
Show more Show less

What is Alhemo®?

Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg 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 factor VIII inhibitors or hemophilia B with factor IX inhibitors.

  • It is not known if Alhemo® is safe and effective in people receiving ongoing immune tolerance induction (ITI) or in children younger than 12 years of age

What is Alhemo®?

Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg 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 factor VIII inhibitors or hemophilia B with factor IX inhibitors.

  • It is not known if Alhemo® is safe and effective in people receiving ongoing immune tolerance induction (ITI) or in children younger than 12 years of age

Important Safety Information

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 (HCP). Do not stop using Alhemo® without talking to your HCP. If you miss doses or stop using Alhemo®, you may no longer be protected against bleeding
  • Your HCP may prescribe bypassing agents during treatment with Alhemo®. Carefully follow your HCP’s instructions regarding when to use on-demand bypassing agents, and the recommended dose and schedule for breakthrough bleeds

Do not use Alhemo® if you are allergic to concizumab-mtci or any of the ingredients in Alhemo®.

Important Safety Information

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 (HCP). Do not stop using Alhemo® without talking to your HCP. If you miss doses or stop using Alhemo®, you may no longer be protected against bleeding
  • Your HCP may prescribe bypassing agents during treatment with Alhemo®. Carefully follow your HCP’s instructions regarding when to use on-demand bypassing agents, and the recommended dose and schedule for breakthrough bleeds

Do not use Alhemo® if you are allergic to concizumab-mtci or any of the ingredients in Alhemo®.

Before using Alhemo®, tell your HCP about all of your medical conditions, including if you:

  • Have a planned surgery. Talk to your HCP about when to stop using Alhemo® and when to start it again if you have a planned surgery
  • Are pregnant, breastfeeding, or plan to become pregnant or to breastfeed. It is not known if Alhemo® may harm your unborn baby or if Alhemo® passes into your breast milk
    • Your HCP may do a pregnancy test before you start treatment with Alhemo®.
    • Females who are able to become pregnant, talk to your HCP about using effective birth control (contraception) methods during treatment with Alhemo® and for 7 weeks after ending treatment

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and supplements.

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 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; and 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; and fast heartbeat

The most common side effects of Alhemo® include: bruising, redness, bleeding, or itching at the site of injection, and hives. These are not all the possible side effects of Alhemo. Call your doctor for medical advice about side effects.

Please see Prescribing Information and Medication Guide for Alhemo®.

Alhemo® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information

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 (HCP). Do not stop using Alhemo® without talking to your HCP. If you miss doses or stop using Alhemo®, you may no longer be protected against bleeding
  • Your HCP may prescribe bypassing agents during treatment with Alhemo®. Carefully follow your HCP’s instructions regarding when to use on-demand bypassing agents, and the recommended dose and schedule for breakthrough bleeds

Do not use Alhemo® if you are allergic to concizumab-mtci or any of the ingredients in Alhemo®.

Before using Alhemo®, tell your HCP about all of your medical conditions, including if you:

  • Have a planned surgery. Talk to your HCP about when to stop using Alhemo® and when to start it again if you have a planned surgery
  • Are pregnant, breastfeeding, or plan to become pregnant or to breastfeed. It is not known if Alhemo® may harm your unborn baby or if Alhemo® passes into your breast milk
    • Your HCP may do a pregnancy test before you start treatment with Alhemo®.
    • Females who are able to become pregnant, talk to your HCP about using effective birth control (contraception) methods during treatment with Alhemo® and for 7 weeks after ending treatment

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and supplements.

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 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; and 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; and fast heartbeat

The most common side effects of Alhemo® include: bruising, redness, bleeding, or itching at the site of injection, and hives. These are not all the possible side effects of Alhemo. Call your doctor for medical advice about side effects.

Please see Prescribing Information and Medication Guide for Alhemo®.

Alhemo® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is Alhemo®?

Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg 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 factor VIII inhibitors or hemophilia B with factor IX inhibitors.

  • It is not known if Alhemo® is safe and effective in people receiving ongoing immune tolerance induction (ITI) or in children younger than 12 years of age

What is Alhemo®?

Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg 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 factor VIII inhibitors or hemophilia B with factor IX inhibitors.

  • It is not known if Alhemo® is safe and effective in people receiving ongoing immune tolerance induction (ITI) or in children younger than 12 years of age

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