HEPATITIS B IMMUNE GLOBULIN

HEPATITIS B IMMUNE GLOBULIN
(hep'a-ti-tis)
HepaGam B, HyperHep, Nabi-HB
Classifications: vaccine;
Therapeutic: vaccine

Prototype: Hepatitis B vaccine
Pregnancy Category: C

Availability

1 mL, 4 mL, 5 mL vials

Action

Sterile solution of immunoglobulins [immunoglobulin G (IgG)] prepared by a special process using pooled human plasma. The possibility of transmission of hepatitis infection or AIDS from H-BIG is remote.

Therapeutic Effect

Preparation contains a high antibody titer specific to hepatitis B surface antigen (anti-HBs); plasma does not show serologic evidence of hepatitis B surface antigen (HBsAg).

Uses

Prophylactically to provide passive immunity to hepatitis B infection in individuals exposed to HBV or HBsAg-positive materials (blood plasma, serum). Also as postexposure prophylaxis after bite or percutaneous exposure, ingestion, direct mucous membrane contact, sexual or intimate contact, and in neonates born to HBsAg-positive women. Prevention of hepatitis B reccurrence following liver transplant (HepaGam B only).

Contraindications

Pregnancy (category C).

Cautious Use

History of systemic allergic reactions to immune globulin, concurrent administration of immunosuppression drugs; thrombocytopenia or bleeding disorders, HBsAg-positive individuals, patients with specific immunoglobulin A (IgA) deficiency; lactation.

Route & Dosage

Hepatitis B Prophylaxis
Adult/Child: IM 0.06 mL/kg as soon as possible after exposure, preferably within 24 h, but no later than 7 d, repeat 28–30 d after exposure

Newborn Exposure
Child: IM 0.5 mL as soon as possible after birth, but no later than 24 h, repeat dose 3 and 6 mo later

Prevention of Recurrence Post-Liver Transplant (HepaGram B)
Adult: IV 20,000 U/dose daily (days 1–7), every 2 wk (week 2–12), monthly thereafter

Administration

Intramuscular
  • Give hepatitis B immune globulin at the same time or up to 1 mo preceding hepatitis B vaccination (hepatitis B vaccine) does not impair the active immune response from the vaccination.
  • Give preferably into deltoid muscle or anterolateral aspect of thigh.
  • Note: For neonates and small children the preferred injection site is the anterolateral aspect of the thigh.
  • DO NOT administer by IV; inadvertent IV or intravascular administration can cause a precipitous fall in BP and an anaphylactic reaction.
  • Store at 2°–8° C (36°–46° F) unless otherwise directed. Avoid freezing.

Adverse Effects (≥1%)

Body as a Whole: Muscle stiffness; pain, tenderness, swelling, erythema of injection site, nausea, faintness, fever, dizziness, malaise, lassitude, body and joint pain, leg cramps. Skin: Urticaria, rash, angioedema, pruritus, erythema, sensitization (following large or repeated doses), anaphylaxis (rare).

Interactions

Drug: May interfere with immune response to live-virus vaccines (measles/mumps/rubella/poliovirus).

Pharmacokinetics

Absorption: Slowly absorbed from IM site. Onset: 1–6 d. Peak: 3–11 d. Duration: 2–6 mo. Elimination: Half-life 21 d.

Nursing Implications

Assessment & Drug Effects

  • Have epinephrine 1:1000 readily available; hypersensitivity reactions are most likely to occur in patients receiving large doses or repeated injections.

Patient & Family Education

  • Learn potential adverse reactions.

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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