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%).
Click here for full Prescribing Information.
References: 1. HEPLISAV-B [package insert]. Berkeley, CA: Dynavax Technologies Corporation; 2017. 2. Centers for Disease Control and Prevention. Recommended immunization schedule for adults aged 19 years or older, United States, 2017. https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf. Accessed January 23, 2017. 3. Walayat S, Ahmed Z, Martin D, Puli S, Cashman M, Dhillon S. Recent advances in vaccination of non-responders to standard dose hepatitis B virus vaccine. World J Hepatol. 2015;7(24):2503-2509. 4. Centers for Disease Control and Prevention. Hepatitis B. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:149-174. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf. Accessed January 23, 2017. 5. Centers for Disease Control and Prevention. Exposure to blood: what healthcare personnel need to know. https://www.cdc.gov/hai/pdfs/bbp/exp_to_blood.pdf. Updated July 2003. Accessed January 23, 2017. 6. Starr SP, Raines D. Cirrhosis: diagnosis, management, and prevention. Am Fam Phys. 2011;84(12):1353-1359. 7. Centers for Disease Control and Prevention. Use of hepatitis B vaccination for adults with diabetes mellitus: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2011;60(50):1709-1711. 8. Keefe EB. Hepatitis A and B superimposed on chronic liver disease: vaccine-preventable diseases. Trans Am Clin Climatol Assoc. 2006;117:227-238. 9. Centers for Disease Control and Prevention. Viral hepatitis surveillance: United States, 2015. https://www.cdc.gov/hepatitis/statistics/2015surveillance/pdfs/2015HepSurveillanceRpt.pdf. Accessed January 23, 2017. 10. Centers for Disease Control and Prevention. Viral hepatitis. https://www.cdc.gov/hepatitis/statistics. Updated May 11, 2017. Accessed January 23, 2017. 11. Harris AM, Iqbal K, Schillie S, et al. Increases in acute hepatitis B virus infections–Kentucky, Tennessee, and West Virginia, 2006-2013. MMWR Morb Mortal Wkly Rep. 2016;65(3):47-50. doi:http://dx.doi.org/10.15585/mmwr.mm6503a2. 12. Engerix-B [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2015. 13. Recombivax HB [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2014. 14. Nelson JC, Bittner RCL, Bounds L, et al. Compliance with multiple-dose vaccine schedules among older children, adolescents, and adults: results from a vaccine safety datalink study. Am J Public Health. 2009;99(suppl 2):S389-S397. 15. Mast EE, Weinbaum CM, Fiore AE, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: immunization of adults. MMWR Recomm Rep. 2006;55(RR-16):1-33. 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.