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Hemgenix Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Customized kit—1 (10–48 vials)
Manufacturer
Generic Availability
NO
Mechanism of Action
Hemgenix is an adeno-associated virus vector-based gene therapy designed to deliver a copy of a gene encoding the Padua variant of human coagulation Factor IX (hFIX-Padua). A single intravenous dose of Hemgenix results in cell transduction and increase in circulating Factor IX activity in patients with Hemophilia B.
Hemgenix Indications
Indications
Hemophilia B in adults who: currently use Factor IX prophylaxis, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
Hemgenix Dosage and Administration
Adult
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
Not established.
Hemgenix Contraindications
Not Applicable
Hemgenix Boxed Warnings
Not Applicable
Hemgenix Warnings/Precautions
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 Pharmacokinetics
See Literature
Hemgenix Interactions
Not Applicable
Hemgenix Adverse Reactions
Adverse Reactions
Elevated ALT/AST, blood creatine kinase elevations, headache, flu-like symptoms, infusion-related reactions, fatigue, malaise.
Hemgenix Clinical Trials
See Literature
Hemgenix Note
Not Applicable
Hemgenix Patient Counseling
See Literature
