Important Safety Information  |  Prescribing Information  |  Medication Guide

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.

 

[Hi] [Hello] [Mr./Ms./Dr.] [Good morning] [Good afternoon] [Hey] [recipient firstname] [recipient lastname],

I'm excited to share some new information with you about a prophylaxis treatment in a prefilled pen – Alhemo^®! It's now indicated for people living with hemophilia B with or without inhibitors or hemophilia A with or without inhibitors.

Below is some information about Alhemo^®. Let's set up some time, so we can chat through any questions you have.

More than a pen—

Your everyday bleed protection^a

Prophylaxis treatment in a prefilled, subcutaneous pen to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with hemophilia B with or without inhibitors or hemophilia A with or without inhibitors.

^aIt is important to follow the daily dosing schedule of Alhemo^® to stay protected against bleeding.

Transformative administration with a prefilled pen^b

Subcutaneous administration (no need for vein access)

^bRead the Instructions for Use for information about how to prepare and inject Alhemo^®, and how to properly throw away used pens and needles. Your healthcare provider should show you or your caregiver how to use Alhemo^® before you use it for the first time.

^cNeedles provided separately and may require a prescription in some states. A new needle is required for each injection.

^dStore in refrigerator before first use. After first use, Alhemo^® can be stored at room temperature below 86 °F (30 °C) or in a refrigerator at 36 °F to 46 °F (2 °C to 8 °C) for up to 4 weeks.

Please see Prescribing Information for full storage information.

Keep scrolling to learn more about Alhemo^®

Important Safety Information

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

Please click here or scroll below for additional Important Safety Information.

Alhemo^® is an innovative approach to preventing bleeds in hemophilia B and A with or without inhibitors

Alhemo^® helps keep blood in balance

It’s 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.

^eAfter your Day 1 loading dose, the amount of Alhemo^® builds up in the body to a stable amount around Day 4 and remains stable with daily maintenance doses. If you stop Alhemo^®, 90% of it is expected to leave the body by the end of approximately 4 days after the last dose. The time for 50% of drug to leave the body is approximately 1 day.

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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.

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:

• 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:

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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