Safety

RIXUBIS® safety profile

During clinical development in a combined study, 99 male PTPs received a total of 14,018 infusions of RIXUBIS and were treated with RIXUBIS for a median of 156 exposure days (range: 8 to 316 days), with a median number of 163 infusions (range: 8 to 327 infusions).1

In clinical trials, after 14,018 infusions, no development of neutralizing inhibitors to factor IX. No severe allergic reactions. In clinical trials, after 14,018 infusions, no development of neutralizing inhibitors to factor IX. No severe allergic reactions.

*Low-titer, non-neutralizing antibodies against factor IX were observed in 21 (21.2%) subjects at one or more time points. No clinical adverse findings were observed in any of these 21 subjects.1

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

Allergic reactions have been reported 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.

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.

RIXUBIS® is manufactured using a validated 2-step virus inactivation and removal process1

1st Step: Solvent or detergent treatment. 2nd Step: 15 nanometer nanofiltration. 1st Step: Solvent or detergent treatment. 2nd Step: 15 nanometer nanofiltration.

Developed by Shire

Shire has over 60 years of dedicated history to the hematology and rare disorders communities.

RIXUBIS is a third-generation recombinant factor IX, produced by DNA technology. No human or animal proteins are added during any stage of manufacturing or formulation of RIXUBIS.1,6,7

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

Please read below for Indications and Detailed Important Risk Information for RIXUBIS. See full Prescribing Information.

Indications for RIXUBIS [Coagulation Factor IX (Recombinant)]

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)]

You should not use RIXUBIS if you are allergic to hamsters or any ingredients in 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 nursing, are pregnant or planning to become pregnant, or have been told that you have inhibitors to factor IX.

Allergic reactions have been reported 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.

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.

If you have risk factors for developing blood clots, the use of factor IX products may increase the risk of abnormal blood clots.

Common side effects that have been reported with RIXUBIS include: unusual taste in the mouth, limb pain, and atypical blood test results.

Call your healthcare provider right away about any side effects that bother you or if your bleeding does not stop after taking RIXUBIS.

Please see RIXUBIS full Prescribing Information.

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.