Bleeding disorders:

Recent Updates:

Monograph added.

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.

Adult Dosage:

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). 

Children Dosage:

Not established. 

HEMGENIX Warnings/Precautions:

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.

HEMGENIX Classification:

Adeno-associated virus vector-based gene therapy.

Adverse Reactions:

Elevated ALT/AST, blood creatine kinase elevations, headache, flu-like symptoms, infusion-related reactions, fatigue, malaise.

Generic Drug Availability:

NO

How Supplied:

Customized kit—1 (10–48 vials)