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HEPATITIS B VACCINE (RECOMBINANT)

Medical Diagnosis and Drugs, Medications
HEPATITIS B VACCINE (RECOMBINANT)
(hep'a-ti-tis)
Engerix-B, Recombivax HB
Classifications: vaccine;
Therapeutic: 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)

Action

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 Effect

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; pregnancy (category C).

Cautious Use

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

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.

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

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