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 [Coagulation Factor IX (Recombinant)] is an antihemophilic factor indicated in adults and children with hemophilia B for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis.
RIXUBIS is not indicated for induction of immune tolerance in patients with hemophilia B.
Detailed Important Risk Information for RIXUBIS [Coagulation Factor IX (Recombinant)]
RIXUBIS is contraindicated in patients who have:
Known hypersensitivity to RIXUBIS or its excipients including hamster protein
Disseminated Intravascular Coagulation (DIC)
Signs of fibrinolysis
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions (including symptoms such as dyspnea and pruritus) have been reported with RIXUBIS. Anaphylaxis and other hypersensitivity reactions are possible. Early signs of allergic reactions, which can progress to anaphylaxis, include angioedema, chest tightness, hypotension, lethargy, nausea, vomiting, paresthesia, urticaria, rash, restlessness, wheezing, and dyspnea. Immediately discontinue administration and initiate appropriate treatment if allergic- or anaphylactic-type reactions occur.
Development of neutralizing antibodies (inhibitors) to factor IX may occur. Regularly evaluate patients for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected factor IX plasma activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor IX inhibitor concentration. Patients with factor IX inhibitors are at an increased risk of severe hypersensitivity reactions or anaphylaxis if re-exposed to RIXUBIS.
Nephrotic syndrome has been reported following attempted immune tolerance induction with factor IX products in hemophilia B patients that have factor IX inhibitors. The safety and efficacy of using RIXUBIS for immune tolerance induction have not been established.
The use of factor IX containing products has been associated with the development of thromboembolic complications. Monitor patients for early signs of thromboembolic and consumptive coagulopathy, when administering RIXUBIS to patients with liver disease, with signs of fibrinolysis, peri- and post-operatively, or at risk for thromboembolic events or DIC.
Common adverse reactions observed in >1% of subjects in clinical studies were: dysgeusia, pain in extremity, and positive test for furin antibody.
The following class adverse reactions have been seen with another recombinant factor IX: inadequate factor IX recovery, inhibitor development, anaphylaxis, angioedema, hypotension, and thrombosis.
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
BAXJECT, B the Inspiration Logo, FREEDOM OF CHOICE, and RIXUBIS are trademarks or registered trademarks of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.