Indications for: HEMGENIX
Hemophilia B in adults who: currently use Factor IX prophylaxis, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
See full labeling. Perform Factor IX inhibitor titer testing and liver assessments (ALT, AST, ALP, bilirubin) prior to treatment. Give as IV infusion at a rate of 500mL/hr (8mL/min). 2×1013gc/kg (2mL/kg).
Monitor for infusion reactions during and for ≥3hrs after completion; manage appropriately if occurs. Hepatotoxicity. Monitor transaminase levels once weekly for 3 months after administration; if liver enzyme elevations developed, continue to monitor until return to baseline. Preexisting risk factors for hepatocellular carcinoma (eg, cirrhosis, advanced hepatic fibrosis, hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, and advanced age), perform regular (eg, annual) liver ultrasound and alpha-fetoprotein testing after administration. Monitor for Factor IX activity and appropriate testing for development of Factor IX inhibitors. Advanced hepatic impairment (including cirrhosis, advanced liver fibrosis, or uncontrolled Hepatitis B and C), severe renal impairment, ESRD: not studied. Not intended for use in women.
Adeno-associated virus vector-based gene therapy.
Elevated ALT/AST, blood creatine kinase elevations, headache, flu-like symptoms, infusion-related reactions, fatigue, malaise.
Generic Drug Availability:
Customized kit—1 (10–48 vials)