Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Dynavax GmbH, Eichsfelder Strasse 11, D-40595 Düsseldorf, Germany
HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
The use of HEPLISAV B should be in accordance with official recommendations.
It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
The vaccine is administrated intramuscularly.
Two doses of 0.5 ml each: an initial dose followed by a second dose 1 month later.
The need for a booster dose has not been established. Subjects who are immunocompromised or who have chronic renal failure may require a booster dose. See section 4.4
No dose adjustment is required. See section 5.1.
The safety and efficacy of HEPLISAV B in children less than 18 years of age have not been established. No data are available.
HEPLISAV B should be injected intramuscularly (IM) in the deltoid region. Injection into the gluteal region (buttocks) should be avoided.
No cases of overdose have been reported.
3 years.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
0.5 ml of solution in a pre-filled syringe (Type I glass) with tip cap (synthetic isoprene-bromobutyl rubber blend) and plunger stopper (chlorobutyl rubber). Syringes are provided without needles in packages of 5 syringes. The tip caps and stoppers of the prefilled syringes do not contain natural rubber latex.
HEPLISAV B is a clear to slightly opalescent, colourless to slightly yellow liquid and should be essentially free of visible particles. Do not administer if it appears otherwise.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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