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.