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. Your HCP may stop treatment with Alhemo^® before your 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 or plan to become pregnant. It is not known if Alhemo^® may harm your unborn baby
  Females who are able to become pregnant
  • Your HCP may do a pregnancy test before you start treatment with Alhemo^®.
  • You should use an effective birth control (contraception) method during treatment with Alhemo^® and for 7 weeks after ending treatment. Talk to your HCP about birth control methods that you can use during this time
• Are breastfeeding or plan to breastfeed. It is not known if Alhemo^® passes into your breast milk. Talk to your HCP about the best way to feed your baby during treatment with Alhemo^®

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your HCP and pharmacist when you get a new medicine.

How should I use Alhemo^®?

• Change (rotate) your injection site with each injection. Do not use the same site for each injection
• To determine the right maintenance dose for you, your HCP will do a blood test to check the amount of Alhemo^® in your blood. Your HCP may do additional blood tests during treatment with Alhemo^®
• Do not share your Alhemo^® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them
• If you miss a dose of Alhemo^® during the first 4 weeks of treatment, contact your HCP right away. Your HCP will tell you how much Alhemo^® to inject
  

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 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
• 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.

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.