Brand and Other Names:Gamastan, IM Immune Globulins, more...ISG
- Classes: Immune Globulins
Dosing & Uses
Dosage Forms & Strengths
- 150-180mg protein/mL
Hepatitis A Pre-exposure Prophylaxis
Anticipated risk of exposure 3 months or greater: 0.06 mL/kg
Repeat dose q4-6months if exposure continues
Prophylaxis (immunocompromised): 0.5 mL/kg IM; not to exceed 15 mL; administer immediately following exposure
Other Indications & Uses
Agammaglobulinemia or hypogammaglobulinemia
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Generalized pain (3.6%)
Muscle stiffness at IM injection site
Injection site pain
Black Box Warnings
- Thrombosis may occur regardless of the route of administration
- Risk factors include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors
- Thrombosis may occur in the absence of known risk factors
- For patients at risk of thrombosis, administer at the minimum concentration available and at the minimum rate of infusion practicable
- Ensure adequate hydration in patients before administration
- Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity
Hypersensitivity to gamma globulin, thimerosal
Isolated IgA deficiency
Severe thrombocytopenia or coagulation disorders
Hyperprolinemia (Hizentra contains the stabilizer L-proline)
Doses >10 mg: use multiple injection sites (pain reduction)
Thrombocytopenia or other bleeding disorders: bleeding risk
IgA deficiency, coagulopathies
Use IV form if higher levels or rapid action is needed
Subcutaneous administration associated with increased risk of hematoma
Postpone live virus vaccines for at least 3 months
Hemolytic anemia reported (monitor)
Aseptic meningitis syndrome reported
Renal dysfunction or renal failure has been associated with IG therapy; monitor renal function and urine output
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not known if excreted in breast milk
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.
Mechanism of Action
Pooled human immune globulins from donors used as replacement therapy for primary and secondary immunodeficiencies, and IgG antibodies against viral, bacteria, parasitic, and mycoplasma antigens; provides passive immunity through an increase in atibody titer and antigen-antibody reaction potential
Half-Life: 23 days (IM); 14-24 days (IV)
Duration: 3-4 weeks
Vd: 0.09-0.13 L/kg
Peak Plasma Time: 2.9 days
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