Immune Globulin IM IGIM Hepatitis Uses Side Effects

Immune Globulin IM IGIM Hepatitis Uses Side Effects

immune globulin IM (IGIM)

Immune globulin IM (IGIM) is a solution of antibodies administered intramuscularly (IM) to prevent viral, bacterial, and parasitic diseases in persons exposed or at risk for exposure to these microorganisms.

Immune globulin is prepared from pooled donor plasma, the liquid component of blood, and is used to strengthen immunity in people with immunodeficiencies.

Immune globulin IM solution contains primarily immunoglobulin G (IgG) antibodies, which provide passive immunization by increasing circulating antibodies. These antibodies recognize antigens unique to specific pathogens, neutralizing them or marking them for destruction by the immune system.

Immune globulin IM is used in the prevention of infection in the following diseases:

  • Hypogammaglobulinemia, a disorder with low serum antibody levels
  • Agammaglobulinemia, an inherited condition with extremely low serum antibodies

Warnings

  • Do not administer immune globulin IM to patients with:
  • Severe systemic hypersensitivity or anaphylactic reactions to human immune globulin.
  • Immunoglobulin A (IgA) deficient people with antibodies against IgA and a history of hypersensitivity.
  • Risk factors for thrombosis include advanced age, prolonged immobilization, hypercoagulable disorders, history of thrombosis, hyperviscosity of blood, cardiovascular risk factors, indwelling central vascular catheters, and use of estrogens. Evaluate patients before initiating therapy and in those at risk for thrombosis, do not exceed the recommended dosage, ensure adequate hydration, and monitor for signs and symptoms of thrombosis. Inform patients about thrombosis risk and symptoms and advise them to report thrombosis symptoms immediately.
  • Side Effects of immune globulin IM

    Common side effects include:

    • Hypersensitivity reactions such as rash, hives, swelling, flushing, shortness of breath, and severe allergic reactions.
    • Pain and tenderness, inflammation.

    Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

    • Serious heart symptoms including fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness.
    • Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.
    • Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out.
    • Serious eye symptoms including blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
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    This is not an exhaustive list of side effects or adverse reactions. Contact your doctor or report side effects to the FDA at 1-800-FDA-1088.

    Dosages of immune globulin IM

    Injectable solution

    • GamaSTAN
    • 16.5% protein/mL (2-mL, 5-mL single-dose vials)
    • 15-18% (150-180 mg/mL), (2-mL, 5-mL, 10-mL single-dose vials)

    Adult and Pediatric:

  • 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 once in 2 months for longer stays
    • Anticipated risk of exposure less than 3 months: 0.02 mL/kg
    • Anticipated risk of exposure 3 months or longer: 0.06 mL/kg
    • Repeat dose once every 4-6 months if exposure continues
    • Alternate ACIP recommendations (see MMWR 2017;66[36];959–960)
    • 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 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 within 1 year and pregnant women without evidence of immunity
      • 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 (Only Adult)
        • Indicated to modify rubella in exposed pregnant women who will not consider a therapeutic abortion
        • Do not give routine prophylaxis of rubella in early pregnancy to an unexposed woman
        • 0.55 mL/kg/dose IM within 72 hours of exposure
        • Varicella
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          • 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
              • If a child is above 12 months and has received GamaSTAN, give the 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 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

                Drug Interactions

                Talk to your doctor about potential drug interactions before starting or changing any medications.

                • No severe interactions have been reported with immune globulin IM.
                • Some serious interactions include:
                • axicabtagene ciloleucel
                • brexucabtagene autoleucel
                • ciltacabtagene autoleucel
                • idecabtagene vicleucel
                • lisocabtagene maraleucel
                • tisagenlecleucel
                • BCG vaccine live
                • efgartigimod alfa
                • 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
                • ethotoin
                • fosphenytoin
                • phenytoin
                • protein a column

                These are not all the possible interactions or adverse effects. Check with your doctor or pharmacist for more information.

                Always inform your doctor or healthcare provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of this information.

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                Pregnancy and breastfeeding

                • No available data exist on the safety of immune globulin IM administration in pregnant women or its effects on reproductive capacity or fetal development. Use during pregnancy should only occur when clearly needed.
                • No data exist on the presence of immune globulin IM in breastmilk or its effects on production or the breastfed infant. The decision to breastfeed during treatment should consider the maternal clinical need for therapy, developmental and health benefits, and potential risks to the infant from drug exposure or the mother’s underlying condition.

                Other information about immune globulin IM

                • Avoid live attenuated vaccines such as mumps, rubella, and varicella for 6 months and measles (rubeola) vaccine for at least a year after receiving immune globulin IM.
                • Inform your healthcare provider immediately if you experience hypersensitivity or severe allergic reactions after receiving IGIM, or symptoms of thrombosis such as pain and/or swelling of an arm or leg, warmth over the affected area, shortness of breath, chest pain, rapid pulse, numbness or weakness on one side of the body, or vision changes.

                Summary

                Immune globulin IM (IGIM) is a solution of antibodies administered intramuscularly (IM) to prevent viral, bacterial, and parasitic diseases in persons exposed or at risk for exposure to these microorganisms. It is used in replacement therapy for people with immunodeficiencies. Common side effects include hypersensitivity reactions, injection site reactions, nausea, headache, fever, and fatigue.

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