Dosing and uses of Gamastan (immune globulin IM (IGIM))
Adult dosage forms and strengths
injectable solution
- 150-180mg protein/mL
Hepatitis A Pre-exposure Prophylaxis
Anticipated risk of exposure <3 months: 0.02 mL/kg
Anticipated risk of exposure 3 months or greater: 0.06 mL/kg
Repeat dose q4-6months if exposure continues
Measles (Rubeola)
Prophylaxis (immunocompetent): 0.25 mL/kg/dose IM; not to exceed 15 mL; administer within 6 days of exposure
Prophylaxis (immunocompromised): 0.5 mL/kg IM; not to exceed 15 mL; administer immediately following exposure
Rubella
Prophylaxis in pregnancy: 0.55 mL/kg/dose IM within 72 hr of exposure
Varicella
Prophylaxis: 0.6-1.2 mL/kg IM within 72 hr of exposure if zoster Ig not available
Immunoglobulin Deficiency
1.3 mL/kg IM initially; follow with 0.66 mL/kg/dose q3-4wk
Other Indications & Uses
Postexposure prophylaxis
Agammaglobulinemia or hypogammaglobulinemia
Pediatric dosage forms and strengths
Safety and efficacy not established
Gamastan (immune globulin IM (IGIM)) adverse (side) effects
1-10%
Chills (8.9%)
Headache (5.4%)
Generalized pain (3.6%)
Pain
Muscle stiffness at IM injection site
Urticaria
Injection site pain
Nausea/vomiting
Fever
Lethargy
Anaphylaxis
Angioneurotic edema
Nephrotic syndrome
Warnings
Black box warnings
Thrombosis
- 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
Contraindications
Hypersensitivity to gamma globulin, thimerosaL
Isolated IgA deficiency
Severe thrombocytopenia or coagulation disorders
Hyperprolinemia (Hizentra contains the stabilizer L-proline)
Cautions
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 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 Gamastan (immune globulin IM (IGIM))
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
Pharmacokinetics
Half-Life: 23 days (IM); 14-24 days (IV)
Onset: Immediate
Duration: 3-4 weeks
Vd: 0.09-0.13 L/kg
Peak Plasma Time: 2.9 days
