Managing hemophilia with inhibitors can bring challenges

Hemophilia B with inhibitors
Hemophilia B with inhibitors
Hemophilia A with inhibitors

Living with hemophilia B with inhibitors, you may face serious challenges and potential risks with limited treatment options.

Bleeds can lead to joint damage, so having preventative treatment is essential

In a real-world study of people with hemophilia, including hemophilia B with inhibitors:

Median Annual Bleed Rate

Blood drop and 18

Bleeds per year

when using bypassing agents on demand
(16 people)a

Blood drop and 10

Bleeds per year

when using bypassing agents as prophylaxis

(15 people)a

aThis study looked at past records of patients with hemophilia, including 31 male adults and adolescents aged 12 years and older who have hemophilia B with inhibitors, of any severity. It aimed to learn more about their everyday needs. In the study, 16 of them used bypassing agents only when a bleed happened (on demand), and on average, they used this treatment for about 9 years (111 months). The other 15 people used these treatments as a preventive prophylaxis, doing so for around 7 years (85 months) on average. The study also looked at how often bleeds happened each year (median bleeds per year).

Until now, your only option for bleed protection has left you vulnerable to

Allergic reaction icon

Severe allergic reactions
(anaphylaxis)

Steps icon

Numerous IV administration
steps
including mixing

Needle and vial icon

Multiple IV infusions per week for prophylaxis

You deserve daily bleed protection with a treatment made with your challenges in mind

For people living with hemophilia A with inhibitors, you deserve more options to protect against bleeds

Unpredictable bleeds persist

~50% (70 people) of patients on nonfactor therapy that works like Factor 8 (Factor 8 mimetic) experienced at least 1 spontaneous bleed.

In a real-world observational study conducted by the Israeli National Hemophilia Center that observed the breakthrough bleeding patterns were analyzed in patients with severe hemophilia A, with or without inhibitors, receiving prophylactic Factor 8 mimetic therapy and completing ≥18 months of follow-up (n=28 patients with hemophilia A with inhibitors). Results include people who have hemophilia A with or without inhibitors (42 patients without inhibitors). Findings have not been confirmed by a clinical or randomized controlled trial.

~55% of patients on bypassing agent prophylaxis experienced at least 1 spontaneous bleed.

In a study conducted in Europe that observed real-world use of aPCC for patients with hemophilia A with inhibitors or hemophilia B with inhibitors, receiving aPCC treatment on demand or prophylactically for more than 4 years in routine clinical practice (n=36 patients with hemophilia A with inhibitors and 1 patient with hemophilia B with inhibitors received aPCC prophylaxis). Findings have not been confirmed by a clinical or randomized control trial.

aPCC=activated prothrombin complex concentrate.

TALK TO YOUR DOCTOR about a solution that helps address your needs and supports you in achieving your goals.

Heavy treatment burden adds to the challenge

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Time-consuming administration

Nonfactor therapy can take up to 15 minutes to prepare and inject with vials and syringes.

Syringe icon

Pain and discomfort

May include using large, thick needles (23G-27G) for injections.

Syringe and vial icon

Complicated administration

Multiple steps and supplies to prepare and administer treatment.

You should expect your treatment to work the way you need it to

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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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