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Important Safety Information | | | Prescribing Information | | | Medication Guide
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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 or B with or without factor VIII or 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.
Alhemo® is a SubQ non-factor treatment that works differently than factor.
Alhemo® does not replace or mimic factor like treatments you may be used to. Alhemo® helps keep blood in balance by helping the body create the right amount of thrombin and keeps Alhemo® levels consistent to avoid peaks and troughs.a
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aIt is important to take Alhemo® daily, especially during the first 4 weeks, to ensure you get the correct maintenance dose and stay protected from bleeding. Always use Alhemo® exactly as prescribed. Do not stop or miss doses without first consulting your healthcare provider, as this may reduce your protection against bleeding. To find the right maintenance dose for you, your provider will check Alhemo® levels in your blood. Additional blood tests may be done during treatment.
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Important Safety Information for 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 (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 factor VIII, factor IX, or bypassing agents during treatment with Alhemo®. Carefully follow your HCP’s instructions regarding when to use on-demand factor VIII, factor IX, or bypassing agents and the recommended dose and schedule for breakthrough bleeds
Please click here or scroll below for additional Important Safety Information.
Choosing a treatment doesn't need to be a headache—you’ve got backup! Meet your Novo Nordisk Rare Blood Community Liaison (RBCL).
RBCLs are dedicated to the hemophilia community with decades of experience providing one-on-one support. Once your doctor prescribes Alhemo®, your RBCL can help you navigate through the complexities of treatment options, including by serving as your point of contact with NovoCare®, so you can focus on what really matters: you and your family.
Your RBCL has information and resources for you, including a shared decision-making guide to prepare you for a conversation with your doctor about Alhemo®, assistance with NovoCare® support programs, tools to help you manage your bleeding disorder, and much more.
Meet your RBCL
You can also learn more about NovoCare® by calling 1-844-668-6732 or visiting NovoCare.com
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 or B with or without factor VIII or 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 (cont’d)
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 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, itching, rash or lump at the injection site, headache, 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.
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