hepatitis B vaccine, recombinant
Engerix-B, Recombivax HB, Recombivax HB Dialysis Formulation

Available forms
Available by prescription only
Injection: 5 mcg HBsAg/0.5 ml (Recombivax HB pediatric/adolescent formulation); 10 mcg HBsAg/ 0.5 ml (Engerix-B, pediatric/adolescent injection); 10 mcg HBsAg/ml (Recombivax HB); 20 mcg HBsAg/ml (Engerix-B); 40 mcg HBsAg/ml (Recombivax HB Dialysis Formulation)

Indications and dosages
 Immunization against infection from all known subtypes of hepatitis B; primary preexposure prophylaxis against hepatitis B; postexposure prophylaxis (when given with hepatitis B immune globulin).
Engerix-B.
Adults age 20 and older: Initially, give 20 mcg (1-ml adult formulation) I.M., followed by a second dose of 20 mcg I.M. 30 days later. Give a third dose of 20 mcg I.M. 6 months after the initial dose.
Neonates and children age 19 and younger: Initially, give 10 mcg (0.5-ml pediatric/adolescent formulation) I.M., followed by a second dose of 10 mcg I.M. 30 days later. Give a third dose of 10 mcg I.M. 6 months after the initial dose.
Adults undergoing dialysis or receiving immunosuppressive therapy: Initially, give 40 mcg I.M. (divided into two 20-mcg doses and administered at different sites). Follow with a second dose of 40 mcg I.M. in 30 days, a third dose after 2 months, and a final dose of 40 mcg I.M. 6 months after the initial dose.
 Note: Alternative dosing schedule in certain populations (neonates born to infected mothers, persons recently exposed to the virus, and travelers to high-risk areas) who may receive the initial vaccine dose (20 mcg for adults and children older than age 10, and 10 mcg for neonates and children up to age 10) followed by a second dose in 1 month and the third dose after 2 months. For prolonged maintenance of protective antibody titers, a booster dose is recommended 12 months after the initial dose.
Recombivax HB
Adults age 20 and older: Initially, give 10 mcg (1-ml adult formulation) I.M., followed by a second dose of 10 mcg I.M. 30 days later. Give a third dose of 10 mcg I.M. 6 months after the initial dose.
Neonates and children up to age 19: Initially, give 5 mcg (0.5-ml pediatric/adolescent formulation) I.M., followed by a second dose of 5 mcg I.M. 30 days later. Give a third dose of 5 mcg I.M. 6 months after initial dose.
 Alternatively, adolescents ages 11 to 15 can be given two doses of the Recombivax HB adult formulation (10 mcg/dose), with the second dose given 4 to 6 months after the first.
Neonates born to HBsAg-positive mothers: Initially, give 5 mcg (0.5-ml pediatric/adolescent formulation) I.M. with 0.5 ml hepatitis B immune globulin. Follow with a second dose of 5 mcg I.M. 30 days later. Give a third dose of 5 mcg I.M. 6 months after the initial dose.
Adults undergoing dialysis or receiving immunosuppressive therapy: Initially, give 40 mcg I.M. (1-ml dialysis formulation). Follow with a second dose of 40 mcg I.M. in 30 days, and give a final dose of 40 mcg I.M. 6 months after the initial dose.

Pharmacodynamics
Prophylactic action: Hepatitis B vaccine promotes active immunity to hepatitis B.

Pharmacokinetics
Absorption: No information available.

Contraindications and precautions
Contraindicated in patients hypersensitive to yeast because recombinant vaccines are derived from yeast cultures. Use cautiously in patients with active infections or compromised cardiac and pulmonary status and in those for whom a febrile or systemic reaction could pose a risk.

Interactions
Drug-drug. Corticosteroids, immunosuppressants: May impair the immune response to hepatitis B vaccine. Larger-than-usual doses of vaccine may be needed to develop adequate circulating antibody levels.

Adverse reactions
CNS: headache, dizziness, insomnia, paresthesia, neuropathy, transient malaise, slight fever.
EENT: pharyngitis.
GI: nausea, anorexia, diarrhea, vomiting.
Musculoskeletal: arthralgia, myalgia.
Skin: local inflammation, soreness (at injection site).
Other: flulike symptoms, anaphylaxis.

Effects on lab test results
None reported.

Overdose and treatment
No information available.

Special considerations
• Have epinephrine solution 1:1,000 available to treat anaphylaxis.
• The Centers for Disease Control and Prevention report that response to hepatitis B vaccine is significantly better after injection into the deltoid rather than the gluteal muscle.
• Hepatitis B vaccine may be administered S.C., but only to persons (such as hemophiliacs and patients with thrombocytopenia) who are at risk of hemorrhage from I.M. injection. Don’t administer I.V.
• Hepatitis B vaccine may be given simultaneously, but at different sites, with hepatitis B immune globulin, influenza virus vaccine, Haemophilus influenzae type B conjugate vaccine, polyvalent pneumococcal vaccine, or diphtheria, tetanus, and pertussis vaccine.
• Although not needed for most patients, serologic testing (to confirm immunity to hepatitis B after the three-dose regimen) is recommended for patients older than age 50, those at high risk of needlestick injury (who might require postexposure prophylaxis), hemodialysis patients, immunocompromised patients, and those who inadvertently received one or more injections into the gluteal muscle.
Pregnant patients
• Use drug in pregnant women only when benefits outweigh risks.
Breast-feeding patients
• Use drug cautiously in breast-feeding women.
Pediatric patients
• Routine immunization is recommended for all neonates, regardless of whether the mother tests positive or negative for HBsAg. It’s usually well tolerated and highly immunogenic in children and infants of all ages. However, it’s most effective in neonates who weigh 2 kg (4.4 lb) or more. To minimize cumulative exposure to mercury in infants younger than age 6 months, especially neonates and those born prematurely, the use of thimerosal-free hepatitis B vaccine is recommended.

Patient education
• Tell patient that there’s no risk of contracting HIV infection or AIDS from hepatitis B vaccine because it’s synthetically derived.
• Explain that hepatitis B vaccine provides protection against hepatitis B only, not against hepatitis A or hepatitis C.
• Tell patient to expect some discomfort at injection site and possible fever, headache, or upset stomach. Recommend acetaminophen to relieve such effects. Encourage patient to report distressing adverse reactions.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use