immune globulin IM (IGIM) (Rx)

Brand and Other Names:GamaSTAN, IM Immune Globulins, more...ISG, GamaSTAN S/D
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Dosing & Uses

AdultPediatric

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
    • Anticipated risk of exposure <1 month: 0.1 mL/kg IM  
    • Anticipated risk of exposure 1-2 months: 0.2 mL/kg IM; repeat dose q2Months for longer stays
  • 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
    • Anticipated risk of exposure <1 month: 0.1 mL/kg IM  
    • Anticipated risk of exposure 1-2 months: 0.2 mL/kg IM; repeat dose q2Months for longer stays
  • 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
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Interactions

Interaction Checker

and immune globulin IM (IGIM)

No Results

     activity indicator 
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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            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.

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              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

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              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
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              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.

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              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)

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              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

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              Images

              No images available for this drug.
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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.