MOA

A UNIQUE APPROACH THAT HELPS CLOSE THE CLINICAL GAP IN PROTECTION1

How does HEPLISAV-B achieve such high rates of protection with 2 doses in 1 month?

Heplisav-B Diagram

Unlike traditional 3-dose vaccines that use an alum adjuvant with no specific cellular response, HEPLISAV-B combines a yeast-derived recombinant hepatitis B surface antigen (HBsAg) with the proprietary adjuvant, 1018, to activate Toll-like receptor 9 (TLR9) expressed on first-responder immune cells for direct immune stimulation.

The proprietary antigen is taken up by the TLR9-expressing antigen-presenting cell to trigger a cascade of robust immunostimulatory responses. This may induce a highly specific, helper T-cell response to generate memory T and B cells.

INDICATION AND IMPORTANT SAFETY INFORMATION
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 (e.g., 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%).

Please see full Prescribing Information.

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INDICATION AND IMPORTANT SAFETY INFORMATION
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 (e.g., 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%).

Please see full Prescribing Information.

References:

1. 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; July 28, 2017; Silver Spring, MD.