Generic Name: Hepatitis B Vaccine[RECOMBINANT](hep´a-ti-tis)
Brand Name:Engerix-B, Recombivax HB
Classifications:antiinfective; vaccine
Pregnancy Category:C
Availability
10 mcg/mL, 5 mcg/0.5 mL, 40 mcg/mL (Recombivax); 20 mcg/mL, 10 mcg/0.5 mL (Engerix-B)
Actions
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.
Therapeutic effects
The recommended 3-dose regimen produces active immunity against hepatitis B infection by inducing protective antibody (anti-HBs) formation.
Uses
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.
Contraindications
History of allergic reaction to hepatitis B vaccine or to any ingredient in the formulation; HBsAg carriers. Safe use during pregnancy (category C) and lactation is not established.
Cautious use
Compromised cardiopulmonary status, serious active infection or fever; thrombocytopenia or other bleeding disorders.
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
Administration
Intramuscular
- 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
BodyWhole:Mild local tenderness at injection site, local inflammatory reaction (swelling, heat, redness, induration, pain); fever, malaise, fatigue, headache, dizziness, faintness, leg cramps, myalgia, arthralgia.
GI:Nausea,vomiting, diarrhea.
Skin:Rash,urticaria, pruritus.
interaction drug:No clinically significant interactions established.
Nursing implications
Assessment & Drug Effects
- Note:The ACIP recommends serologic confirmation of postvaccination immunity in patients undergoing dialysis and in immunodeficient patients.
- 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
- Learn potential adverse reaction.
- Do not breast feed while taking this drug without consulting physician.
