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FDA Updates

FDA approves PreHevbrio: The first 3-antigen HBV vaccine for adults

PreHevbrio [Hepatitis B Vaccine (Recombinant)]: contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S.A.

INDICATIONS AND USAGE: 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.

DOSAGE AND ADMINISTRATION :For intramuscular injection. Administer a series of three doses (1.0 mL each) of PREHEVBRIO on a 0-, 1 and 6-month schedule.

CONTRAINDICATIONS: Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PREHEVBRIO.

ADVERSE REACTIONS: Injection site pain, tenderness, headache (most common), fatigue and myalgia.

Source: FDA

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