*The annualized bleed rate (ABR) for all bleeds decreased from an average of 4.1 for prophylaxis during the lead-in period to 1.9 in months 7–18 after treatment, an ABR ratio of 0.46 (95% CI: 0.26, 0.81).
David
Factor IX level of
37% for years
Patient portrayal; HEMGENIX not
intended for women
A one-time infusion delivers significant bleed protection*
Explore treatment guides, locate a HEMGENIX administration site, and more
Discover resources*The annualized bleed rate (ABR) for all bleeds decreased from an average of 4.1 for prophylaxis during the lead-in period to 1.9 in months 7–18 after treatment, an ABR ratio of 0.46 (95% CI: 0.26, 0.81).
Connect with CSL Behring Medical Affairs to find additional information and ask questions.
Warning and Precautions
Infusion Reactions
Infusion reactions, including hypersensitivity reactions and anaphylaxis, may occur. Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or interrupt administration. Re-start administration at a slower infusion once resolved.
Hepatotoxicity/Hepatocellular Carcinoma
Post-dose, monitor for elevated transaminase levels. Consider corticosteroid treatment should elevations occur. The integration of liver-targeting AAV vector DNA into the genome may carry the theoretical risk of hepatocellular carcinoma development. For patients with preexisting risk factors for hepatocellular carcinogenicity, perform regular (eg, annual) abdominal ultrasound and alpha-fetoprotein testing following administration.
Immune-mediated neutralization of the AAV5 vector capsid
Preexisting neutralizing anti-AAV antibodies may impede transgene expression at desired levels.
Monitoring Laboratory Tests
In addition to monitoring liver function, monitor for Factor IX activity and Factor IX inhibitors after administration.
Adverse Reactions
The most common adverse reactions (incidence ≥5%) were elevated ALT, headache, blood creatine kinase elevations, flu-like symptoms, infusion-related reactions, fatigue, nausea, malaise, and elevated AST.
Indication
HEMGENIX®, etranacogene dezaparvovec-drlb, is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who:
HEMGENIX is for single use intravenous infusion only.
Contraindications: None.
Please see full prescribing information for HEMGENIX.
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
