Drug Detail:Hepatitis b vaccine recombinant (monograph) (Engerix-b)
Drug Class:
Usual Adult Dose for Hepatitis B Prophylaxis
Primary Vaccination:
Engerix-B(R):
19 years and younger: Three doses (0.5 mL each) intramuscularly on a 0, 1, and 6 month schedule
20 years and older: Three doses (1 mL each) intramuscularly on a 0, 1, and 6 month schedule
Heplisav-B(R): Two doses (0.5 mL each) intramuscularly one month apart
Recombivax-HB(R):
19 years and younger: Three doses (0.5 mL each) intramuscularly on a 0, 1, and 6 month schedule (use pediatric/adolescent formulation)
20 years and older: Three doses (1 mL each) intramuscularly on a 0, 1, and 6 month schedule (use adult formulation)
Known or Presumed Hepatitis B Exposure:
Engerix-B(R) : Use recommended doses of (above) on a 0, 1, and 6 month schedule OR a 0, 1, 2, and 12 month schedule.
Recombivax-HB(R): Refer to recommendations of the Advisory Committee on Immunization Practices (ACIP)
Comments:
- Administer hepatitis B immune globulin if appropriate.
- Start hepatitis B vaccine as soon as possible after exposure.
Renal Dose Adjustments
Recombivax HB Dialysis Formulation(R):
Predialysis patients: Three doses (40 mcg/1 mL each), IM, on a 0, 1, and 6 month schedule
Engerix-B(R) and Heplisav-B(R): Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Alternate dosing schedules (Engerix-B(R)):
11 to 19 years: 3 doses (1 mL each), IM, on a 0, 1, and 6 month schedule
11 to 19 years: 4 doses (1 mL each), IM, on a 0, 1, 2, and 12 month schedule
20 years and older: 4 doses (1 mL each), IM, on a 0, 1, 2, and 12 month schedule
Booster doses:
Engerix-B(R):
Adults: 1 mL intramuscularly
Adults on hemodialysis: 2 mL (or two 1 mL doses) as determined by annual antibody testing showing antibody levels below 10 mIU/mL
Recombivax-HB(R):
Adults: Refer to recommendations of the Advisory Committee on Immunization Practices (ACIP)
Predialysis/Dialysis Adults:
- Consider a booster dose or revaccination with Recombivax-HB Dialysis Formulation(R) when anti-HB levels are less than 10 mIU/mL one to two months after the third dose.
- Give a booster dose when annual testing shows anti-HB levels are less than 10 mIU/mL.
Dialysis
Hemodialysis:
Engerix-B(R): Four doses (2 mL each) intramuscularly at 0, 1, 2, and 6 months
Heplisav-B(R): Safety and efficacy have not been established in hemodialysis
Recombivax-HB(R) Dialysis formulation: Three 40 mcg (1 mL) doses intramuscularly at 0, 1, and 6 months
Peritoneal dialysis: Data not available
Other Comments
Administration advice:
- Administer IM; the preferred site is the anterolateral aspect of the thigh in patients under 1 year, and the deltoid muscle for older children and adults.
- Do not administer in the gluteal region: response may be suboptimal.
- Administer subcutaneously only in patients at risk of hemorrhage from IM injections.
IV compatibility:
- Do not mix with any other vaccine or product in the same syringe/vial.
General:
Health care providers should report any allergic or unusual adverse reactions to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (USA) and the manufacturer.