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Hemgenix is a prescription adeno-associated virus serotype 5 gene therapy containing etranacogene dezaparvovec-drlb. It is indicated for adults with hemophilia B who use factor IX prophylaxis, have a current or historical life-threatening hemorrhage, or have repeated serious spontaneous bleeding episodes. Treatment is given once by intravenous infusion.
read more about hemgenix ...Hemgenix carries a gene encoding the Padua variant of human coagulation factor IX. The AAV5 vector transfers this genetic material into liver cells, which then produce factor IX protein. A single infusion increases circulating factor IX activity and can reduce dependence on routine factor IX replacement.
Hemgenix is used in adults with hemophilia B who meet the bleeding or prophylaxis criteria in current labeling. Baseline evaluation includes testing for factor IX inhibitors and assessment of liver health. Factor IX activity and inhibitor development are monitored after treatment.
The recommended dose is 2 ? 10^13 genome copies per kg of body weight as a single intravenous infusion after dilution with 0.9 percent sodium chloride. The infusion rate does not exceed 500 mL per hour. Patients are observed during the infusion and for at least three hours afterward for hypersensitivity or infusion-related reactions.
Serious concerns include hypersensitivity and infusion-related reactions, liver toxicity, immune-mediated reduction of treatment activity, and a potential risk of hepatocellular carcinoma. ALT is checked weekly for three months and monthly through one year. Patients at high risk for hepatocellular carcinoma undergo abdominal ultrasound and serum alpha-fetoprotein monitoring for five years.
Hemgenix treats hemophilia B in adults who meet the current bleeding or factor IX prophylaxis criteria.
Hemgenix is administered as a single intravenous infusion.
The recommended dose is 2 ? 10^13 genome copies per kg of body weight.
Liver enzyme elevations can occur after treatment, so ALT is monitored closely during the first year.
DailyMed - HEMGENIX (etranacogene dezaparvovec-drlb) kit. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=35b2db65-4c6c-4173-ab56-b2bca69193bd. Date Accessed October 1, 2026.
Etranacogene Dezaparvovec. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/Etranacogene-Dezaparvovec. Date Accessed October 1, 2026.
Etranacogene Dezaparvovec-drlb Injection. MedlinePlus. https://medlineplus.gov/druginfo/meds/a623001.html. Date Accessed October 1, 2026.
HEMGENIX. U.S. Food and Drug Administration. https://www.fda.gov/vaccines-blood-biologics/vaccines/hemgenix. Date Accessed October 1, 2026.
HEMGENIX (etranacogene dezaparvovec-drlb) Prescribing Information. CSL Behring. https://labeling.cslbehring.com/PI/US/Hemgenix/EN/Hemgenix-Prescribing-Information.pdf. Date Accessed October 1, 2026.