Adult Dosing
Hepatitis B immunization
Engerix-B
- 18-19 yrs
- 0.5 mL (10 mcg) IM given at 0, 1 and 6 months
20 yrs- 1 mL (20 mcg) IM given at 0, 1 and 6 months
- Hemodialysis patients
- 2 mL (40 mcg) IM given at 0, 1, 2 and 6 months; give a 2-mL booster dose when antibody levels fall below 10 mIU/mL
Recombivax HB
- 18-19 yrs (Adolescent/Pediatric Formulation)
- 0.5 mL (5 mcg) IM given at 0, 1 and 6 months
- 20 yrs (Adult Formulation)
- 1 mL (10 mcg) IM given at 0, 1 and 6 months
Recombivax HB Dialysis Formulation
- Predialysis/dialysis patients
- 1 mL (40 mcg) IM given at 0, 1 and 6 months
Notes:- Administer by IM injection; may be given SC to individuals at risk of hemorrhage following IM injections. Avoid IV or intradermal administration
- The preferred site of injection is the deltoid muscle for adults; do not inject in the gluteal region
- Alternate dosing and administration schedules are available for high-risk patients
Pediatric Dosing
Hepatitis B immunization
Engerix-B
- From birth through 18 yrs
- 0.5 mL (10 mcg) IM given at 0, 1 and 6 months
- When administration of a booster dose is indicated, the dose is 0.5 mL for children
10 yrs and 1 mL for children 11 yrs
Recombivax HB Pediatric/Adolescent Formulation
- 0-18 yrs
- 0.5 mL (5 mcg) IM given at 0, 1 and 6 months
Recombivax HB Adult Formulation
- Children 11-15 yrs
- 1 mL (10 mcg) IM given at 0 and 4-6 months
Notes:- Administer by IM injection; may be given SC to individuals at risk of hemorrhage following IM injections. Avoid IV or intradermal administration
- The preferred sites of injection is the anterolateral aspect of the thigh for infants/young children and the deltoid muscle for older children; do not inject in gluteal muscle
- Infants born to mothers with positive/unknown HBsAg status should be immunized within 12 hrs of birth along with hepatitis B immune globulin (HBIG)
- Alternate dosing and administration schedules are available for high-risk patients
[Outline]
See Supplemental Patient Information
- Certain vials stoppers (Recombivax HB) and the syringe tip caps or plunger stoppers may contain natural rubber latex and dry natural latex rubber. Use of these products may cause allergic reactions in patients sensitive to latex
- Use of hepatitis B vaccine in infants weighing <2 kg born to HBsAg negative mothers must be postponed; vaccination can be administered at chronological age 1 month or hospital discharge. Infants weighing <2 kg born to mothers with positive or unknown HBsAg status may be vaccinated along with HBIG administration within 12 hrs of birth
- Apnea may occur in certain premature infants following IM vaccination. Such infants should be vaccinated only after assessment of potential risks and benefits of vaccination based on consideration of the hepatitis B antigen status of the mother and the probability of maternal viral transmission to infants born of HBsAg positive mothers if vaccination is delayed
- Vaccination should be deferred in patients with moderate-severe acute febrile illness, unless they are at immediate risk of hepatitis B infection
- Immune response of the vaccine may be diminished in immunocompromised individuals and those on immunosuppressant therapy
- Vaccine may not prevent hepatitis B infection in individuals with unrecognized hepatitis B infection at the time of vaccine administration and those who do not achieve protective antibody titers
- Prior to immunization, obtain the patient's immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks
- Patients who experience symptoms suggestive of hypersensitivity following initial dose must not be given further doses. Keep epinephrine (1:1000) and other appropriate agents readily available for management of possible anaphylactic reaction following vaccination
- Exercise caution while administering the vaccine to individuals with severely compromised cardiopulmonary status or to others in whom a febrile or systemic reaction could pose a significant risk
Cautions: Use cautiously in
- Hypersensitivity to latex
- Multiple sclerosis
- Severely compromised cardiopulmonary status
- Patients >60 yrs
Supplemental Patient Information
- Educate vaccine recipients and parents/guardians of the potential benefits and risks associated with vaccination, as well as the importance of completing the immunization series
- Inform vaccine recipients and parents/guardians that the vaccine contains non-infectious purified HBsAg and is not capable of causing hepatitis B infection
- Instruct parents or guardians and vaccine recipients to report any adverse events to their physicians
Pregnancy Category:C
Breastfeeding: According to the CDC and other health professional organizations, hepatitis B vaccines given to nursing mothers do not affect the safety of breastfeeding for mothers or breastfed infants. Breastfeeding is not a contraindication to hepatitis B vaccine. Breastfeeding also appears to reduce infant side effects associated with routine childhood immunization. Routinely vaccinate breastfed infants as per recommended schedules. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 August 2011). Manufacturer advises caution.
US Trade Name(s)
US Availability
Engerix-B
- INJ: 10 mcg/0.5 mL (0.5 mL vial)
- INJ: 20 mcg/mL (1 mL vial)
- INJ: 10 mcg/0.5 mL (0.5 mL pre-filled syringe)
- INJ: 20 mcg/mL (1 mL pre-filled syringe)
Recombivax HB (Pediatric Formulation)
- INJ: 5 mcg/0.5 mL (0.5 mL vial)
- INJ: 5 mcg/0.5 mL (0.5 mL pre-filled syringe)
Recombivax HB (Adult Formulation)
- INJ: 10 mcg/mL (1 mL vial)
- INJ: 10 mcg/mL (1 mL pre-filled syringe)
Recombivax HB (Dialysis Formulation)
- INJ: 40 mcg/mL (1 mL vial)
Canadian Trade Name(s)
Canadian Availability
Engerix-B
- INJ: 10 mcg/0.5 mL (0.5 mL vial)
- INJ: 20 mcg/mL (1 mL vial)
- INJ: 100 mcg/5 mL (5 mL multi-dose vial)
- INJ: 200 mcg/10 mL (10 mL multi-dose vial)
Recombivax HB (Pediatric Presentation)
- INJ: 5 mcg/0.5 mL (3 mL vial)
Recombivax HB (Adult Presentation)
- INJ: 10 mcg/mL (3 mL vial)
- INJ: 10 mcg/mL (4 mL multi-dose vial)
Recombivax HB (Adult Dialysis Presentation)
- INJ: 40 mcg/mL (3 mL vial)
UK Trade Name(s)
UK Availability
Engerix-B
- INJ: 10 mcg/0.5 mL (0.5 mL vial)
- INJ: 20 mcg/mL (1 mL vial)
- INJ: 20 mcg/mL (1 mL pre-filled syringe)
HBVAXPRO
- INJ: 5 mcg/0.5 mL (0.5 mL pre-filled syringe)
- INJ: 10 mcg/mL (1 mL pre-filled syringe)
- INJ: 40 mcg/mL (1 mL vial)
Australian Trade Name(s)
Australian Availability
Engerix-B
- INJ: 10 mcg/0.5 mL (vial)
- INJ: 10 mcg/0.5 mL (pre-filled syringe)
- INJ: 20 mcg/mL (vial)
- INJ: 20 mcg/mL (pre-filled syringe)
H-B-VAX II (Paediatric Formulation)
- INJ: 5 mcg/0.5 mL (vial)
- INJ: 5 mcg/0.5 mL (prefilled syringe)
H-B-VAX II (Adult Formulation)
- INJ: 10 mcg/1 mL (vial)
- INJ: 10 mcg/1 mL (prefilled syringe)
H-B-VAX II (Dialysis Formulation)
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Recombivax HB 10 MCG/ML SUSP [Vial] (MERCK SHARP & DOHME)
1 ml = $73.99
3 ml = $211.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.