Roctavian

Have resuscitation equipment available. Monitor for infusion reactions during and for ≥3hrs after completion; slow or interrupt if occurs; discontinue for anaphylaxis. Hepatotoxicity. Perform liver function tests (eg, ALT, AST, GGT, ALP, total bilirubin, INR). Monitor ALT weekly for ≥26 weeks post-administration and as clinically indicated (see full labeling); consider repeat testing within 24–48hrs to confirm ALT elevation prior to corticosteroid treatment. If ALT ≥1.5×baseline or above ULN, consider corticosteroid treatment (see full labeling). Perform ultrasound, elastography, or lab assessments for liver fibrosis. Monitor factor VIII activity (see full labeling); consider more frequent testing if activity levels ≤5 IU/dL and evidence of bleeding. Monitor for the development of factor VIII inhibitors after administration. Increased risk for thromboembolic events. Perform regular liver ultrasound (annually) and AFP testing for 5yrs in those with risk factors for hepatocellular carcinoma (eg, hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, advanced age). Ensure up to date vaccinations prior to infusion. For 6 months after infusion, advise males of reproductive potential (w. female partners) to use effective contraception; and do not donate semen. Not intended for use in women.