Immune Globulin IM (IGIM)

Immune globulin IM (IGIM) is used for prophylaxis following exposure to hepatitis A; to prevent or modify measles (rubeola) in a susceptible person exposed fewer than 6 days previously; for susceptible household contacts of measles patients, particularly contacts under 1 year and pregnant women without evidence of immunity; to modify rubella in exposed pregnant women who will not consider a therapeutic abortion; for prophylaxis to varicella; and for agammaglobulinemia or hypogammaglobulinemia.

Immune globulin IM (IGIM) is available under the following different brand names: GamaSTAN, IM Immune Globulins, ISG, and GamaSTAN S/D.

Dosages of Immune Globulin IM (IGIM):

Dosage Forms and 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)

Dosage Considerations – Should be Given as Follows:

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 less than 1 month: 0.1 mL/kg IM
  • Anticipated risk of exposure 1-2 months: 0.2 mL/kg IM; repeat dose every 2 months for longer stays

• GamaSTAN S/D
  • Anticipated risk of exposure less than 3 months: 0.02 mL/kg
  • Anticipated risk of exposure 3 months or more: 0.06 mL/kg
  • Repeat dose every 4-6 months 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 the manifestation of disease
• Not needed if at least 1 dose of hepatitis A vaccine was given 1 month or more 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 under 1 year and pregnant women without evidence of immunity

Postexposure prophylaxis

• Immunocompetent: 0.25 mL/kg/dose intramuscularly (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 the 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 hours of exposure

Varicella

• Prophylaxis: 0.6-1.2 mL/kg IM within 72 hours of exposure
• Administer promptly only if varicella-zoster IG (Human) is unavailable

Other Indications and 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 concerning 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 the 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

Side effects of immune globulin IM (IGIM) include:

• Local pain and tenderness at the injection site
• Anaphylactic reaction
• Skin swelling (angioedema)
• Hives
• Postmarketing side effects of immune globulin IM (IGIM) reported include:
• Headache
• Nausea
• Injection site pain
• Injection site inflammation
• Fatigue
• Fever

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Immune globulin IM (IGIM) has no listed severe interactions with other drugs.
• Immune globulin IM (IGIM) has no listed serious interactions with other drugs.
• Moderate interactions of immune globulin IM (IGIM) include:
  • BCG vaccine live
  • measles (rubeola) vaccine
  • measles mumps and rubella vaccine, live
  • measles, mumps, rubella and varicella vaccine, live
  • rubella vaccine
  • smallpox (vaccinia) vaccine, live
  • varicella virus vaccine live
  • Mild interactions of immune globulin IM (IGIM) include:
  • ethotoin
  • fosphenytoin
  • phenytoin
  • protein a column

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains immune globulin IM (IGIM). Do not take GamaSTAN, IM Immune Globulins, ISG, or GamaSTAN S/D if you are allergic to immune globulin IM (IGIM) or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

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 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

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Immune Globulin IM (IGIM)?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Immune Globulin IM (IGIM)?”

Cautions

• Use with caution in patients with a history of prior systemic allergic reactions to human immunoglobulin preparations; do not perform skin tests; 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
• Inject IM only; do not administer IV owing to risk for serious reactions (e.g., renal dysfunction/failure/hemolysis, transfusion-related acute lung injury [TRALI]); do not inject into a blood vessel
• The drug is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent; the 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 and Lactation

• There are no data on the use of immune globulin IM (IGIM) in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted. It is unknown if fetal harm may occur when immune globulin IM (IGIM) is administered to a pregnant woman or if it can affect reproduction capacity. Consult your doctor.
• There is no information regarding the presence of immunoglobulin IM (IGIM) 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 immunoglobulin IM (IGIM), and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.