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Frequently asked questions

Find answers to many commonly asked questions about ALPROLIX®.

Man outside in a vest (patient portrayal)

Frequently asked questions

Find answers to many commonly asked questions about ALPROLIX®.

ALPROLIX is prescription medicine that replaces factor IX in people with hemophilia B. Adults, adolescents, and kids can all use ALPROLIX to prevent and control bleeding.

ALPROLIX can be used on demand. Just 1 infusion of ALPROLIX resolved most bleeds for adults, adolescents, and kids. Your doctor will determine the appropriate on demand dose for you.

Click here to see the benefits of ALPROLIX on demand

ALPROLIX can be used as a prophylaxis (prophy) treatment. This means ALPROLIX can be injected on a regular schedule to help prevent future bleeds.
  • Adults and adolescents on ALPROLIX prophy had a median annualized spontaneous bleed rate (AsBR) of 0.9 bleeds per year. The median overall annualized bleed rate was 1.4 bleeds per year
  • Kids under 12 years of age on ALPROLIX prophy had 0 median AsBR per year. The median overall annualized bleed rate was 2

The recommended starting prophylaxis (prophy) schedule is either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. For kids under 12 years of age, the recommended starting schedule is 60 IU/kg once weekly. Dosing schedules can be adjusted based on your individual response. Your doctor will determine the appropriate dosing schedule for you.

FC Fusion is the science behind ALPROLIX; it helps prolong the half-life of factor IX. Fc Fusion allows ALPROLIX to:

  • Mirror the pathway followed by natural factor IX
  • Leave the bloodstream and travel to areas like tissues, muscles, and joints
  • Degrade naturally into amino acids—without accumulating in the body

ALPROLIX can be used by adults, adolescents, and kids with hemophilia B. You should not use ALPROLIX if you had an allergic reaction to it in the past.

ALPROLIX is administered as an infusion medication into your vein. Your healthcare provider can instruct you on when and how to do infusions on your own and may watch you give yourself your first dose of ALPROLIX.

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Instructions for use

ALPROLIX was approved in 2014. It is the first extended half-life (EHL) factor IX treatment for hemophilia B with over 10 years of experience.

Wondering if ALPROLIX could be right for you? Here are some things you may want to talk about with your doctor:

  • How many infusions I typically have every: week, month, or year
  • On average, how many bleeds I typically have per month
  • How many infusions it typically takes to stop a bleed

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Important Safety Information and Indication

Indication

ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital Factor IX deficiency. Your healthcare provider may give you ALPROLIX when you have surgery.

Important Safety Information

Do not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX.

Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies and all your medical conditions, including if you are pregnant or planning to become pregnant, are breastfeeding, or have been told you have inhibitors (antibodies) to Factor IX.

Common side effects of ALPROLIX include headache, abnormal sensation in the mouth, and pain in your side with blood in your urine, which may be a sign of clot formation in the urinary collecting system.

Allergic reactions may occur with ALPROLIX. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: hives, chest tightness, wheezing, difficulty breathing, or swelling of the face.

Redness to the skin at the injection site may also occur.

ALPROLIX may increase the risk of formation of abnormal blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider or seek emergency care if you have symptoms of a possible abnormal blood clot, which may include: chest pain, difficulty breathing, unexpected swelling of an arm or leg with or without pain or tenderness.

Your body can also make antibodies called "inhibitors" against ALPROLIX, which may stop ALPROLIX from working properly.

These are not all of the possible side effects of ALPROLIX. Talk to your healthcare provider right away about any side effect that bothers you or does not go away, or if bleeding is not controlled using ALPROLIX.
© 2024 Sanofi. All rights reserved. ALPROLIX and Sanofi are registered trademarks of Sanofi or an affiliate. All other trademarks are the property of their respective owners. MAT-US-2021806-V8.0-10/2024 Last updated: October 2024