hepatitis B immune globulin (HBIG) (h big, Hep B Gammagee, HepaGam B, HyperHep, HyperHEP B S/D)
Classes: Immune Globulins
Dosing and uses of h big, Hep B Gammagee (hepatitis B immune globulin (HBIG))
Post Exposure Prophylaxis
Include uninfected sexual partners
0.06 mL/kg IM x1 AND HepB vaccine (subsequently complete full course of vaccination, 28-30 days post initial)
Post-Exposure timeline for vaccination
- < 24 hr post needle stick, ocular, or mucosal exposure
- <14 days post sexual exposure
Prophylaxis for Known Nonresponders to Vaccine or Vaccine Refusal
0.06 mL/kg IM immediately AND a second dose 1 mth later
Liver Transplant (HepaGam only)
Designed to attain serum levels of HBsAb >500 IU/L
- 20,000 IU IV per dose
First dose admin concurrently w/grafting of transplanted liver, THEn
- qD x7 d, THEN q2wk 2-12 wk post-op, THEREAFTER qMth
Hepatitis B Virus Reinfection (Orphan)
Prophylaxis against hepatitis B virus reinfection in liver transplant patients
Orphan indication sponsor
- Biotest Pharmaceuticals Corporation; 5800 Park of Commerce Blvd., NW; Boca Raton, FL 33487
Other Information
Administration: anterolateral thigh or deltoid region
Other Indications & Uses
Acute exposure to HBsAg+ blood
- Needle stick, bite
Infants born to HBsAg+ mothers
Sexual contact with HBsAg+ individuals
Infants <12 mo whose family members are HBsAg+
Prophylaxis against hepatitis B reinfection in HBsAg+ liver transplantees (HepaGam)
Pediatric dosage forms and strengths
Newborns Born to HBs Ag-positive Mothers
0.5 mL IM <12 hr after birth
If vaccination delayed by 3 mth, repeat HBIG at 3 mth
If not vaccinated at all, repeat HBIG at 3 & 6 mth
Postexposure Prophylaxis
<12 yo 0.05 mL/kg IM; initiate HepB vaccine
>12 yo: 0.06 mL/kg IM x1 AND HepB vaccine (subsequently complete full course of vaccination, 28-30 days post initial)
Post-Exposure timeline for vaccination
- < 24 hr post needle stick, ocular, or mucosal exposure
- <14 days post sexual exposure
Other Information
Administration: anterolateral thigh or deltoid region
h big, Hep B Gammagee (hepatitis B immune globulin (HBIG)) adverse (side) effects
>10%
Headache (14%)
Erythema (12%)
1-10%
Myalgia (10%)
Malaise (6%)
Nausea (4%)
Generalized pain, injection site pain (4%)
Vomiting (2%)
Ecchymosis (2%)
<1%
Fever
Lethargy
Chest tightness
Anaphylaxis
Angioneurotic edema
Nephrotic syndrome (rare)
Warnings
Contraindications
Hypersensitivity to human globulin
Cautions
IgA deficiency, thrombocytopenia, coagulopathies
May elevate alk phos, AST, creatinine
May decrease WBC
Do NOT give IV
Separate live vaccines by 3 mth
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if excreted in breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of h big, Hep B Gammagee (hepatitis B immune globulin (HBIG))
Half-Life: 21 d
Peak Plasma Time: average 6.5 d
Vd: 11.2 L
Clearance: 0.35 L/d
Mechanism of action
Pooled human immune globulins from donors
