ASH Clinical News ACN_4.3_FULL-ISSUE-DIGITAL | Page 68

In hemophilia B TAKE CONTROL TO A HIGH LEVEL WITH REBINYN ® Clayton, 34 years old, is a pilot who hikes and camps in his spare time. Clayton lives with hemophilia B. Image of hemophilia B patient shown is for illustrative purposes only. INDICATIONS AND USAGE Rebinyn ® , Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for on demand treatment and control of bleeding episodes and perioperative management of bleeding. Limitations of Use: Rebinyn ® is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B. IMPORTANT SAFETY INFORMATION Contraindications • Rebinyn ® is contraindicated in patients with a known hypersensitivity to Rebinyn ® or its components, including hamster proteins. Warnings and Precautions • Hypersensitivity reactions, including anaphylaxis, may occur. Signs may include angioedema, chest tightness, difficulty breathing, wheezing, urticaria, and itching. Discontinue Rebinyn ® if allergic or anaphylactic-type reactions occur and initiate appropriate treatment. • Development of neutralizing antibodies (inhibitors) to Factor IX may occur. Monitor patients for development of factor IX inhibitors if bleeding is not controlled with the recommended dose of Rebinyn ® or if expected Factor IX activity plasma levels are not attained. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.