- Medicine Name: Roctavian
- API: Valoctocogene Roxaparvovec-rvox
- Dosage Form & Strength: Suspension for Intravenous Infusion
- Manufactured By: BioMarin Pharmaceutical Inc.
Roctavian (valoctocogene roxaparvovec-rvox) is an adeno-associated virus vector-based one-time gene therapy used for the treatment of adults with severe hemophilia A (congenital factor VIII or FVIII deficiency with factor VIII activity < 1 IU/dL) who do not have pre-existing antibodies to the virus, adeno-associated virus serotype 5 (AAV5) which is determined by a blood test.
Recommended Dosage: Roctavian is for one-time single-dose intravenous use only. The recommended dose is 6 × 1013 vector genomes per kilogram (vg/kg) body weight, administered as a single intravenous (IV) infusion. Initiate the infusion at 1 mL/min. In case well-tolerated, the infusion rate may be increased every 30 minutes by 1 mL/min up to a maximum infusion rate of 4 mL/min.
Do baseline testing to choose patients, including testing for pre-existing antibodies to adeno-associated virus serotype 5 (AAV5), FVIII inhibitor existence, and liver health evaluations.
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