| HEPATITIS B VACCINE (RECOMBINANT)
Engerix-B, Recombivax HB
Classifications: vaccine; Therapeutic: vaccine
Pregnancy Category: C
10 mcg/mL, 5 mcg/0.5 mL, 40 mcg/mL (Recombivax); 20 mcg/mL, 10 mcg/0.5 mL (Engerix-B)
Suspension of inactivated and purified hepatitis B surface antigen (HBsAg) derived from human plasma of screened asymptomatic
HBsAg-positive carriers of hepatitis B virus. Hepatitis B vaccine recombinant is the first vaccine produced by gene splicing.
No human plasma is used in its production.
The recommended 3-dose regimen produces active immunity against hepatitis B infection by inducing protective antibody (anti-HBs)
To promote active immunity in individuals at high risk of potential exposure to hepatitis B virus or HBsAg-positive materials.
Has been used simultaneously (into different sites) with hepatitis B immune globulin (H-BIG) for post-exposure prophylaxis
in selected patients and in infants born to HBsAg-positive mothers.
History of allergic reaction to hepatitis B vaccine or to any ingredient in the formulation; HBsAg carriers; pregnancy (category
Compromised cardiopulmonary status, serious active infection or fever; renal disease, renal failure; thrombocytopenia or
other bleeding disorders; lactation.
Route & Dosage
|Hepatitis B Prophylaxis
Adult: IM Recombivax 1 mL (10 mcg) at 0, 1, and 6 mo; Engerix-B 1 mL (20 mcg) at 0, 1, and 6 mo or 0, 1, 2, and 12 mo
Child: IM Recombivax 0.5 mL (5 mcg) at 0, 1, and 6 mo; Engerix-B 0.5 mL (10 mcg) at 0, 1, and 6 mo or 0, 1, 2, and 12 mo
Dialysis and Immunodeficient Patients
Adult: IM Recombivax 2 mL (20 mcg) at 0, 1, and 6 mo; Engerix-B 2 mL (40 mcg) at 0, 1, and 6 mo or 0, 1, 2, and 12 mo
- Give preferably into the deltoid and in neonates into the anterolateral thigh, avoiding blood vessels and nerves. Carefully
aspirate to prevent inadvertent intravascular injection.
- Have epinephrine immediately available to treat anaphylaxis.
- Shake vial well before withdrawing dose to assure uniform suspension.
- Store unopened and opened vials at 2°8° C (36°46° F) unless otherwise directed. Avoid freezing
(freezing destroys potency).
Adverse Effects (≥1%)Body as a Whole: Mild local tenderness at injection site, local inflammatory reaction
(swelling, heat, redness, induration, pain); fever, malaise, fatigue,
headache, dizziness, faintness, leg cramps, myalgia, arthralgia
Nausea, vomiting, diarrhea
Rash, urticaria, pruritus.
No clinically significant interactions established.
Slowly absorbed from IM site. Onset:
2 wk. Peak:
6 mo. Duration:
At least 3 y.
Assessment & Drug Effects
- Note: The ACIP recommends serologic confirmation of postvaccination immunity in patients undergoing dialysis and in immunodeficient
- Monitor temperature. Some patients develop a temperature elevation of 38.3° C (101° F) following vaccination that
may last 1 or 2 d.
Patient & Family Education