HEPATITIS B VACCINE (RECOMBINANT)

(hep'a-ti-tis)
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 (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. GI: Nausea, vomiting, diarrhea. Skin: Rash, urticaria, pruritus.

Interactions

Drug: No clinically significant interactions established.

Pharmacokinetics

Absorption: Slowly absorbed from IM site. Onset: 2 wk. Peak: 6 mo. Duration: At least 3 y.

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.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug