REQUEST MORE INFORMATION
Call 1-84-HEPLISAV (1-844-375-4728) to request general information. To report suspected adverse reactions, call 1-84-HEPLISAV (1-844-375-4728) or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
INDICATION
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%).
There are no clinical studies of HEPLISAV-B in pregnant women. Available human data on HEPLISAV-B administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
It is not known whether HEPLISAV-B is excreted in human milk. Data are not available to assess the effects of HEPLISAV-B on the breastfed infant or on milk production/excretion.
Vaccination with HEPLISAV-B may not result in protection of all vaccine recipients.
ADDITIONAL IMPORTANT INFORMATION
HEPLISAV-B does not treat liver diseases such as cirrhosis or liver cancer.1
Not all liver cancer is caused by the hepatitis B virus.2
Please see accompanying full Prescribing Information. Or visit www.heplisavbhcp.com
References: 1. HEPLISAV-B [package insert]. Emeryville, CA: Dynavax Technologies Corporation; 2023. 2. Hepatitis B Foundation. Risk factors. Accessed May 16, 2024. https://www.hepb.org/research-and-programs/liver/risk-factors-for-liver-cancer
INDICATION
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.