Initial U.S. Approval: 2021
PREHEVBRIO is indicated for prevention of infection caused by all known subtypes of hepatitis B virus.
PREHEVBRIO is approved for use in adults 18 years of age and older.
[U]nsolicited AEs [Adverse Events] that occurred within 28 days… were reported by 48.3%…
Serious Adverse Events (SAEs)
SAEs were reported by 2.5% of subjects…
PREHEVBRIO contains… hepatitis B surface antigens, co-purified from genetically modified CHO (Chinese Hamster Ovary) cells cultured in growth medium containing… fetal bovine serum.
The hepatitis B surface antigens are co-purified from the supernatant of CHO cells by a series of physicochemical steps as virus-like particles containing CHO cell membrane lipids.
Each 1.0 mL dose is formulated to contain 10 mcg hepatitis B surface antigens… adsorbed on aluminum hydroxide [Al(OH)3] as an adjuvant (aluminum content of 0.5 mg/mL).
Each dose may contain residual amounts of CHO [chinese hamster ovary] cell proteins… CHO cell DNA…
PREHEVBRIO has not been evaluated for carcinogenic, mutagenic potential or male infertility in animals.