Eligibility for ROCTAVIAN® (valoctocogene roxaparvovec-rvox) can be determined through a few tests. Patients must be free from antibodies to AAV5 and have no hepatic impairment, among …

Learn about the eligibility criteria for ROCTAVIAN®. Explore the benefits and considerations to determine if it is right for you.

For one-time single-dose intravenous use only. Treatment with ROCTAVIAN should be under the supervision of a physician experienced in the treatment of hemophilia and/or bleeding disorders.

ROCTAVIAN is the only FDA-approved gene therapy for eligible adults with severe hemophilia A. This one-time infusion is matched by personalized product and education support for patients …

Initiation (new start) criteria: Prescribed by Hematology provider Males ≥18 years of age Diagnosis of hemophilia A (congenital factor VIII deficiency) Baseline factor VIII levels <1 …

Test your patients to confirm eligibility, and assess if ROCTAVIAN gene therapy is right for them. Liver ultrasound and elastography or laboratory assessments for assessing hepatic fibrosis. …

Liver function tests (ALT, AST, GGT, ALP, total bilirubin, and INR). Thromboembolic events may occur in the setting of elevated factor VIII activity above the upper limit of normal.

Who is eligible for ROCTAVIAN? ROCTAVIAN is approved for adults with severe hemophilia A who do not have antibodies to the AAV5 virus, which is determined by a blood test.

Because of the specialized skills required for evaluation and diagnosis of patients treated with Roctavian as well as the monitoring required for adverse events and long-term efficacy, …

Eligible participants were adults with severe hemophilia A, with no history of factor VIII inhibitor development and without detectable immunity to the AAV5 capsid. Patients were considered …