Concizumab

What it is used for

Alhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors

The most important thing to know

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. Do not stop using Alhemo without talking to your healthcare provider.

If you miss doses, or stop using Alhemo, you may no longer be protected against bleeding. Your healthcare provider may prescribe factor VIII, factor IX or bypassing agents during treatment with Alhemo. Carefully follow your healthcare provider’s instructions regarding when to use on-demand factor VIII, factor IX or bypassing agents, and the recommended dose and schedule for breakthrough bleeds.

See “How should I use Alhemo?” for more information on how to use Alhemo. What is Alhemo? 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 with or without factor VIII inhibitors hemophilia B with or without factor IX inhibitors It is not known if Alhemo is safe and effective in people while receiving ongoing Immune Tolerance Induction (ITI).

It is not known if Alhemo is safe and effective for hemophilia A and B with and without inhibitors in children younger than 12 years of age. Do not use Alhemo if you are allergic to concizumab-mtci or any of the ingredients in Alhemo. See the end of this Medication Guide for a complete list of ingredients in Alhemo. Before using Alhemo, tell your healthcare provider about all of your medical conditions, including if you: have a planned surgery.

Your healthcare provider may stop treatment with Alhemo before your surgery. Talk to your healthcare provider 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: o Your healthcare provider may do a pregnancy test before you start treatment with Alhemo.

o You should use an effective birth control (contraception) during treatment with Alhemo and for 7 weeks after ending treatment. Talk to your healthcare provider 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 healthcare provider about the best way to feed your baby during treatment with Alhemo. Tell your healthcare provider 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 healthcare provider and pharmacist when you get a new medicine.

How should I use Alhemo? Read the Instructions for Use that comes with Alhemo for information about how to prepare and inject a dose of Alhemo, and how to properly throw away (dispose of) used Alhemo pens and needles. Use Alhemo exactly as prescribed by your healthcare provider. Your healthcare provider will provide instructions for stopping (discontinuing) your current treatment when switching to Alhemo.

Inject Alhemo 1 time a day. Your healthcare provider should show you or your caregiver how to use Alhemo before you use it for the first time. Alhemo is given as an injection under the skin (subcutaneous injection) by you or a caregiver. Ask your healthcare provider if you need to use a different injection technique. For example, children and people who are lean may need to inject into a pinched fold of skin to avoid injecting too deep (into the muscle).

Change (rotate) your injection site with each injection. Do not use the same site for each injection. You will inject a larger dose (a loading dose) of Alhemo on your first day of treatment. Then your healthcare provider will prescribe a dose to inject 1 time a day until your maintenance dose

Side effects, and when to stop

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: o swelling, warmth, pain, or redness of the skin o feeling short of breath or severe chest pain o headache o confusion o trouble speaking or moving o numbness in your face o eye pain or swelling o problems with your vision o sudden pain in your stomach or lower back area Allergic reactions.

Alhemo can cause allergic reactions, including reactions that can be serious. Stop using Alhemo and tell your healthcare provider right away if you have 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: o itching on large areas of skin o redness or swelling of lips, tongue, face, or hands o trouble swallowing o shortness of breath o wheezing o tightness of the chest o pale and cold skin o fast heartbeat o dizziness due to low blood pressure The most common side effects of Alhemo include: bruising, redness, bleeding, itching, rash, or lump at the injection site hives headache These are not all the possible side effects of Alhemo.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

Storing it

Before first use: o Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C). After first use: o Store the Alhemo pen in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C) for up to 28 days. o Write the date of first use in the space provided on the carton. o Throw away (discard) the Alhemo pen 28 days after first opening even if some medicine is left in the pen.

Store Alhemo with the cap on and keep it in the original carton to protect from light. Do not store Alhemo in direct sunlight and keep away from direct heat. When stored in the refrigerator, do not store the pen directly next to the cooling element (the part that cools the refrigerator). Do not freeze Alhemo. Do not use Alhemo if it has been frozen or if it has been stored above 86°F (30°C).

Keep Alhemo and all medicine out of the reach of children.