Dosing & Uses
Dosage Forms & Strengths
injectable solution
GamaSTAN
- 16.5% protein/mL (2-mL, 5-mL single-dose vials)
GamaSTAN S/D
- 15-18% [150-180 mg/mL] (2-mL, 5-mL, 10-mL single-dose vials)
Hepatitis A
Indicated for prophylaxis following exposure to hepatitis A
Hepatitis A vaccine preferred for patients 12 months to 40 years (CDC 2017)
Preexposure prophylaxis upon travel into endemic areas
GamaSTAN
GamaSTAN S/D
- Anticipated risk of exposure <3 months: 0.02 mL/kg
- Anticipated risk of exposure ≥3 months: 0.06 mL/kg
- Repeat dose q4-6months if exposure continues
- Alternate ACIP recommendations (see MMWR 2017;66[36];959–960)
Postexposure prophylaxis
- 0.1 mL/kg given within 14 days of exposure and/or prior to manifestation of disease
- Not needed if at least 1 dose of hepatitis A vaccine was given ≥1 month before exposure (CDC 2017)
Measles
Indicated to prevent or modify measles (rubeola) in a susceptible person exposed fewer than 6 days previously
Also indicated for susceptible household contacts of measles patients, particularly contacts <1 year and pregnant women without evidence of immunity
Postexposure prophylaxis
- Immunocompetent: 0.25 mL/kg/dose IM; not to exceed 15 mL; administer within 6 days of exposure
- Immunocompromised: 0.5 mL/kg IM; not to exceed 15 mL; administer immediately following exposure
Rubella
Indicated to modify rubella in exposed pregnant women who will not consider a therapeutic abortion
Do not give for routine prophylaxis of rubella in early pregnancy to an unexposed woman
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
Administer promptly only if varicella zoster IG (Human) is unavailable
Other Indications & Uses
Agammaglobulinemia or hypogammaglobulinemia
Dosing Considerations
GamaSTAN S/D and measles vaccine should not be given at the same time
Limitations of use
- Not standardized with respect to antibody titers against hepatitis B surface antigen (HBsAg) and must not be used for prophylaxis of viral hepatitis type B; prophylactic treatment to prevent hepatitis B can best be accomplished with use of hepatitis B immune globulin (Human), often in combination with Hepatitis B Vaccine
- Not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, mumps, or varicella
Dosage Forms & Strengths
injectable solution
GamaSTAN
- 16.5% protein/mL (2-mL, 5-mL single-dose vials)
GamaSTAN S/D
- 15-18% [150-180 mg/mL] (2-mL, 5-mL, 10-mL single-dose vials)
Hepatitis A
Indicated for prophylaxis following exposure to hepatitis A
Hepatitis A vaccine preferred for patients 12 months to 40 years (CDC 2017)
Preexposure prophylaxis upon travel into endemic areas
GamaSTAN
GamaSTAN S/D
- Anticipated risk of exposure <3 months: 0.02 mL/kg
- Anticipated risk of exposure ≥3 months: 0.06 mL/kg
- Repeat dose q4-6months if exposure continues
- Alternate ACIP recommendations (see MMWR 2017;66[36];959–960)
Postexposure prophylaxis
- 0.1 mL/kg given within 14 days of exposure and/or prior to manifestation of disease
- Not needed if at least 1 dose of hepatitis A vaccine was given ≥1 month before exposure (CDC 2017)
Measles
Indicated to prevent or modify measles (rubeola) in a susceptible person exposed fewer than 6 days previously
Also indicated for susceptible household contacts of measles patients, particularly contacts <1 year and pregnant women without evidence of immunity
Postexposure prophylaxis
- Immunocompetent: 0.25 mL/kg/dose IM; not to exceed 15 mL; administer within 6 days of exposure (CDC 2017)
- Immunocompromised: 0.5 mL/kg IM; not to exceed 15 mL; administer immediately following exposure (CDC 2017)
Varicella
Prophylaxis: 0.6-1.2 mL/kg IM within 72 hr of exposure (CDC 2017)
Administer promptly only if varicella zoster IG (Human) is unavailable
Other Indications & Uses
Agammaglobulinemia or hypogammaglobulinemia
Dosing Considerations
GamaSTAN S/D and measles vaccine should not be given at the same time
If a child is >12 months and has received GamaSTAN, give measles vaccine about 5 months later when the measles antibody titer will have disappeared
If a susceptible child exposed to measles is immunocompromised, give immediately
Limitations of use
- Not standardized with respect to antibody titers against hepatitis B surface antigen (HBsAg) and must not be used for prophylaxis of viral hepatitis type B; prophylactic treatment to prevent hepatitis B can best be accomplished with use of hepatitis B immune globulin (Human), often in combination with Hepatitis B Vaccine
- Not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, mumps, or varicella
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- axicabtagene ciloleucel
immune globulin IM (IGIM), axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
immune globulin IM (IGIM), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
immune globulin IM (IGIM), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
immune globulin IM (IGIM), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
immune globulin IM (IGIM), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tisagenlecleucel
immune globulin IM (IGIM), tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (8)
- BCG vaccine live
immune globulin IM (IGIM) decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of immune globulin IM (IGIM) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- measles (rubeola) vaccine
immune globulin IM (IGIM) decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- measles mumps and rubella vaccine, live
immune globulin IM (IGIM) decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- measles, mumps, rubella and varicella vaccine, live
immune globulin IM (IGIM) decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- rubella vaccine
immune globulin IM (IGIM) decreases effects of rubella vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- smallpox (vaccinia) vaccine, live
immune globulin IM (IGIM) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- varicella virus vaccine live
immune globulin IM (IGIM) decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
Minor (4)
- ethotoin
ethotoin, immune globulin IM (IGIM). Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis.
- fosphenytoin
fosphenytoin, immune globulin IM (IGIM). Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis.
- phenytoin
phenytoin, immune globulin IM (IGIM). Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis.
- protein a column
protein a column decreases levels of immune globulin IM (IGIM) by Other (see comment). Minor/Significance Unknown. Comment: Since Prosorba binds IgG, it could theoretically interfere with the levels and/or effects of pharmacologic immune globulins.
Adverse Effects
Frequency Not Defined
Local pain and tenderness at injection site
Anaphylactic reaction
Angioedema
Urticaria
Postmarketing Reports
Headache
Nausea
Injection site pain
Injection site inflammation
Fatigue
Pyrexia
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
Anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human)
IgA deficient patients with antibodies against IgA and a history of hypersensitivity
Cautions
Use with caution in patients with a history of prior systemic allergic reactions to human immunoglobulin preparations; do not perform skin test; misinterpretation of such tests can lead to withholding beneficial human immunoglobulin from a patient who is not actually allergic to this material
Thrombosis may occur following treatment with immune globulin products (see Black Box Warnings)
Inject IM only; do not administer IV owing to risk for serious reactions (eg, renal dysfunction/failure/hemolysis, transfusion-related acute lung injury [TRALI]); do not inject into a blood vessel
Drug is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent; drug is purified from human plasma obtained from healthy donors
Drug interactions overview
- Antibodies in immunoglobulin IM may interfere with response to live virus vaccines (eg, measles, mumps, polio, rubella, and varicella); defer live vaccine administration for up to 6 months after administration
Pregnancy & Lactation
Pregnancy
There are no data with use in pregnant women to inform a drug-associated risk
Animal reproduction studies have not been conducted
Unknown if fetal harm may occur when administered to a pregnant woman or can affect reproduction capacity
Lactation
There is no information regarding presence of immunoglobulin IM in human milk, the effect on the breastfed infant, or the effects on milk production
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
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
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
Absorption
Peak levels of immunoglobulin G are obtained ~ 2 days after IM injection
Excretion
Half-Life: 23 days (IM)
Administration
IM Administration
IM administration only
Do not administer SC or IV
Visually inspect vial for particulate matter and discoloration prior to administration
Administer IM, preferably in anterolateral aspects and deltoid muscle of upper thigh
Do not administer in gluteal region due to risk of injury to sciatic nerve
Split injections >10 mL into multiple injections given at different sites; in pediatric patients, consider splitting doses <10 mL based on patient size
Storage
All vials: Store at 2-8°C (36- 46°F); do not freeze; do not use after expiration date
Images
Formulary
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