Valoctocogene Roxaparvovec-Rvox

Contraindications

4 CONTRAINDICATIONS Administration of ROCTAVIAN is contraindicated in: patients with active infections, either acute (such as acute respiratory infections or acute hepatitis) or uncontrolled chronic (such as chronic active hepatitis B) . patients with known significant hepatic fibrosis (stage 3 or 4 on the Batts-Ludwig scale or equivalent), or cirrhosis [see Dosage and Administration (2) ]. patients with known hypersensitivity to mannitol. Active infections, either acute or uncontrolled chronic. ( 4 ) Known significant hepatic fibrosis (stage 3 or 4), or cirrhosis. ( 4 ) Known hypersensitivity to mannitol. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary ROCTAVIAN is not intended for administration in women. There are no data on the use of ROCTAVIAN in pregnant women to inform a drug-associated risk of adverse developmental outcome. Animal reproduction and developmental toxicity studies have not been conducted with ROCTAVIAN. It is not known whether ROCTAVIAN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects occurs in 2 to 4% of the general population and miscarriage occurs in 15 to 20% of clinically recognized pregnancies.