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What is RIXUBIS?

RIXUBIS is an injectable medicine used to replace clotting factor IX that is missing in adults and children with hemophilia B (also called congenital factor IX deficiency or Christmas disease).

RIXUBIS is used to control and prevent bleeding in people with hemophilia B. Your healthcare provider may give you RIXUBIS when you have surgery. RIXUBIS can reduce the number of bleeding episodes when used regularly (prophylaxis).

Detailed Important Risk Information for RIXUBIS [Coagulation Factor IX (Recombinant)]

Who should not use RIXUBIS?

You should not use RIXUBIS if you

• are allergic to hamsters
• are allergic to any ingredients in RIXUBIS

Tell your healthcare provider if you are pregnant or breastfeeding because RIXUBIS may not be right for you.

What should I tell my healthcare provider before using RIXUBIS?

You should tell your healthcare provider if you

• have or have had any medical problems
• take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies
• have any allergies, including allergies to hamsters
• are breastfeeding. It is not known if RIXUBIS passes into your milk and if it can harm your baby
• are pregnant or planning to become pregnant. It is not known if RIXUBIS may harm your unborn baby
• have been told that you have inhibitors to factor IX (because RIXUBIS may not work for you)

What are the possible side effects of RIXUBIS?

Allergic reactions may occur with RIXUBIS. Call your healthcare provider or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.

Some common side effects of RIXUBIS were unusual taste in the mouth and limb pain.

Tell your healthcare provider about any side effects that bother you or do not go away.

Your body may form inhibitors to factor IX. An inhibitor is part of the body’s defense system. If you form inhibitors, it may stop RIXUBIS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for development of inhibitors to factor IX.

Please see RIXUBIS full Prescribing Information and discuss with your healthcare provider.

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.