HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
Important Safety Information
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).
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References: 1. HEPLISAV-B [package insert]. Berkeley, CA: Dynavax Technologies Corporation; 2017.
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16. Dynavax Technologies Corporation. FDA Advisory Committee Briefing Document: HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted]. Presented at: Meeting of the Vaccines and Related Biological Products Advisory Committee; Silver Spring, MD; July 28, 2017.
17. Twinrix [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2016.