Recombivax Hb Pediatric/adolescent Generic Name & Formulations
Legal Class
Rx
General Description
Hepatitis B surface antigen vaccine (recombinant) 5mcg/0.5mL; susp for IM inj; aluminum hydroxide adsorbed; preservative-free.
Pharmacological Class
HB.
How Supplied
Single-dose vials: Ped/Adolescent 5mcg/0.5mL (yellow cap)—1, 10; Adult 10mcg/1mL (green cap)—1, 10; Dialysis 40mcg/1mL (blue cap)—1
Manufacturer
Recombivax Hb Pediatric/adolescent Indications
Indications
Hepatitis B immunization.
Recombivax Hb Pediatric/adolescent Dosage and Administration
Adults and Children
Use correct formulation; see literature. Give IM into anterolateral thigh for children; deltoid for adults. May give SC if risk of hemorrhage. Patients 0–19yrs of age (three-dose regimen): give 1st dose of 5mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Or, for patients 11–15yrs of age, may use alternate two-dose regimen: give 1st dose of 10mcg at elected date and repeat after 4–6 months (2nd dose). Patients ≥20yrs of age: give 1st dose of 10mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Dialysis and pre-dialysis patients: give 1st dose of 40mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose); consider booster dose if antibody levels fall to <10mIU/mL. High-risk infants (mother is HBsAg positive or unknown) or if exposed to HBsAg: give hepatitis B immune globulin also (see literature).
Recombivax Hb Pediatric/adolescent Contraindications
Contraindications
Yeast hypersensitivity.
Recombivax Hb Pediatric/adolescent Boxed Warnings
Not Applicable
Recombivax Hb Pediatric/adolescent Warnings/Precautions
Warnings/Precautions
Have epinephrine inj (1:1000) available. Serious active infection. Severely compromised cardiopulmonary status. Pregnancy (Cat.C). Nursing mothers.
Recombivax Hb Pediatric/adolescent Pharmacokinetics
See Literature
Recombivax Hb Pediatric/adolescent Interactions
Recombivax Hb Pediatric/adolescent Adverse Reactions
Adverse Reactions
Local reactions, irritability, fatigue, headache, fever, malaise, nausea, diarrhea, anorexia, pharyngitis, upper respiratory infection, anaphylaxis.
Recombivax Hb Pediatric/adolescent Clinical Trials
See Literature
Recombivax Hb Pediatric/adolescent Note
Not Applicable
Recombivax Hb Pediatric/adolescent Patient Counseling
See Literature