Initial US Approval: 2017
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus.
HEPLISAV-B is approved for use in adults 18 years of age and older.
Unsolicited adverse events within 28 days following any injection… were reported by 42.0% of HEPLISAV-B recipients and 41.3% of Engerix-B recipients.
The following events were reported… granulomatosis with polyangiitis, lichen planus, Guillain-Barré syndrome, and Grave’s disease.
The percentage of subjects who reported serious adverse events was 6.2% in the HEPLISAV-B group…
An analysis of serious adverse events likely representing myocardial infarction (MI) [heart attack] was conducted… Among the 19 events identified as MI in HEPLISAV-B recipients, three occurred within 14 days…
HEPLISAV-B is prepared by combining the purified HBsAg together with the CpG 1018 adjuvant…
Each 0.5-mL dose is formulated to contain… 3000 mcg of CpG 1018 adjuvant.
HEPLISAV-B has not been evaluated for carcinogenicity, mutagenic potential or male infertility in animals.