
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 2830 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 17), every 2 wk (week 212), 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: 16 d. Peak: 311 d. Duration: 26 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.
Canadian drug name;
Prototype drug