Dosage Forms. Suspension for Intramuscular Injection: Engerix 10 mcg/0.5 mL, 20 mcg/1 mL; Recombivax 5 mcg/0.5 mL, 10 mcg/1 mL, 40 mcg/1 mL; also available in combination with hepatitis A vaccine and in combination products with other pediatric vaccines
Common FDA Label Indication, Dosing, and Titration.
1. Prevention of hepatitis B infection: Adults ≥20 y, Engerix 20 mcg IM or Recombivax 10 mcg IM given once, with two additional doses given 1 and 5 mo later; Children, Engerix 10 mcg IM or Recombivax 5 mcg IM given once, with two additional doses given 1 and 5 mo later; Patients undergoing hemodialysis, 40 mcg IM given once, with two additional doses given 1 and 5 mo later; several alternative regimens approved for adults and children of varying ages
Off-Label Uses. None
Drug Characteristics: Hepatitis B Vaccine, Recombinant
Medication Safety Issues: Hepatitis B Vaccine, Recombinant
Drug Interactions: Hepatitis B Vaccine, Recombinant. None
Adverse Reactions: Hepatitis B Vaccine, Recombinant
Efficacy Monitoring Parameters. Prevention of hepatitis B infection; measurement of antibody to the surface antigen (anti-HBs) 1-2 mo after dose 3 is recommended for individuals at risk for vaccine nonresponse and is required for those at occupational risk for hepatitis B exposure.
Toxicity Monitoring Parameters. Monitor for hypotension for 15 min after administration.
Key Patient Counseling Points. Return to provider for all doses in the series.
Clinical Pearls. The brands of vaccines are considered interchangeable for the series. Use a needle of appropriate length to assure intramuscular administration. Recommended for all infants, adolescents, healthcare personnel, patients with renal failure, individuals with hepatitis C, residents and staff of institutions for the mentally handicapped, household and contacts of individuals with chronic hepatitis B, those with frequent exposure to blood products, international travelers, those at increased risk due to sexual practices, prisoners, and injection drug users. Lifetime immunity achieved in those with initial response.