Immune Globulin, Intravenous
- Atc Codes:J06BA02
- CAS Codes:145464-27-3
- PHARMGKB ID:145464-27-3
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Endobulin, Flebogammadif, Gammagard, Gamunex, Intratect, Kiovig, Octagam (d), Privigen, Sandoglobulin; Belgium: Gammagard, Multigam, Nanogam, Octagam (d), Sandoglobulin; Bulgaria: Gammagard, Immunovenin-intact, Intraglobin F, Pentaglobin; Cyprus: Intratect, Octagam (d), Gamunex, Vigam; Czech Republic: Flebogamma, Flebogammadif, Gammagard, Gamunex, Kiovig, Octagam (d), Privigen; Denmark: Endobulim, Immunoglobulin, Kiovig, Octagam (d), Privigen; Estonia: Flebogammadif, Kiovig, Octagam (d), Privigen; Finland: Gammagard, Kiovig, Nanogam, Octagam (d), Privigen; France: Gammagard, Kiovig, Octagam (d), Privigen, Sandoglobulin, Tegeline; Germany: Endobulin, Flebogamma, Flebogammadif, Gammagard, Gammonativ, Gamunex, Ig Vena, Intraglobin F, Intratect, Kiovig, Octagam (d), Pentaglobin, Polyglobin, Privigen, Sandoglobulin, Venimmun N; Greece: Flebogamma, Flebogammadif, Gaminex, Gammagard, Intraglobin F, Intratect, Kiovig, Octagam (d), Privigen, Sandoglobulin; Hungary: Kiovig, Gamunex, Intratect, Octagam (d), Pentaglobin; Ireland: Flebogamma, Flebogammadif, Gammagard, Gamunex, Kiovig, Privigen; Italy: Flebogamma, Gammagard, Igvena, Intratect, Kiovig, Sandoglobulin; Latvia: Flebogammadif, Gammagard, Humaglobin, Human Normal Immunoglobulin for Infusion, Kiovig, Octagam (d), Privigen; Lithuania: Flebogammadif, Gammagard, Intraglobin F, Kiovig, Privigen; Luxembourg: Kiovig, Multigam, Octagam (d); Malta: IG Vena, Vigam; Netherlands: Flebogamma, Gammagard, Gamunex, Immunoglobuline, Intratect, Kiovig, Nanogam, Octagam (d); Poland: Bioglobulina, Endobulin, Flebogamma, Flebogammadif, Gamma Venin P, Gammagard, Gamunex, Ig Vena, Intraglobin F, Intratect, Kiovig, Octagam (d), Pentaglobin, Sandoglobulin, Venimmun; Portugal: Flebogamma, Flebogammadif, Gammagard, Gamunex, Ig Vena, Kiovig, Octagam (d), Privigen, Sandoglobulina, Tegeline; Romania: Flebogammadif, Humaglobin, Ig Vena, Kiovig, Octagam (d), Privigen; Slovakia: Flebogamma, Kiovig, Octagam (d); Slovenia: Flebogammadif, Kiovig, Privigen; Spain: Flebogamma, Gammagard, Kiovig, Privigen; Sweden: Flebogammadif, Gammagard, Gamunex, Kiovig, Octagam (d), Privigen, Xepol; UK: Flebogamma, Flebogammadif, Gammaplex, Octagam (d), Privigen, Sandoglobulin, Vigam.
North America
Canada: Gammagard, Gamunex, Privigen, Sandoglobulin; USA: Carimune, Flebogamma, Gammagard, Gammaplex, Gamunex, Octagam (d), Privigen.
Latin America
Argentina: Flebogamma, Gammaglobulina-T, Igg Endovenosa, Inmunoglobulina G Endovenosa, Kiovig, Vigam; Brazil: Armoglobulina P, Gama-Venina; Mexico: Gamma-Venin, Octagam (d), Pentaglobin, Sandoglobulina, Vigam.
Drug combinations
Chemistry
Immune Globulin Intravenous Pentetate: (1) Immunoglobulin G (human polyclonal Macroscint), disulfide with human polyclonal Macroscint light chain, dimer, N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycine conjugate; (2) Immunoglobulin G (human polyclonal Macroscint), disulfide with human polyclonal Macroscint light chain, dimer, N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycine conjugate. CAS-145464-27-3 (1996).
Pharmacologic Category
Serums, Toxoids, and Vaccines; Serums. Immune Globulin. (ATC-Code: J06BA02).
Mechanism of action
Replacement therapy for primary and secondary immunodeficiencies. Interference with F~c~ receptors on cells of reticuloendothelial system for autoimmune cytopenias and ITP. Possible role of contained antiviral-type antibodies.
Therapeutic use
Treatment of primary immunodeficiency syndromes (congenital agammaglobulinemia, severe combined immunodeficiency syndromes, common variable immunodeficiency, X-linked immunodeficiency, Wiskott-Aldrich syndrome). Treatment of immune (idiopathic) thrombocytopenic purpura. Prevention of coronary artery aneurysms associated with Kawasaki disease (in combination with aspirin). Prevention of bacterial infection in B-cell chronic lymphocytic leukemia. Treatment of chronic inflammatory demyelinating polyneuropathy.
Pregnancy and lactiation implications
Recommended for use in fetal-neonatal alloimmune thrombocytopenia and pregnancy-associated ITP.
Unlabeled use
Prevention of serious bacterial infections among HIV-infected children with hypogammaglobulinemia (IgG <400 mg/dL). Hematopoietic stem cell transplantation. Fetal-neonatal alloimmune thrombocytopenia. Pregnancy-associated ITP. Prevention of gastroenteritis in children. Multiple sclerosis. Hemolytic disease of the newborn. HIV-associated thrombocytopenia. Acquired hypogammaglobulinemia secondary to malignancy. Myasthenia gravis. Refractory dermatomyositis/polymyositis.
Contraindications
Hypersensitivity to immune globulin or any component of the formulation. Selective IgA deficiency. Hyperprolinemia.
Warnings and precautions
Hypersensitivity and anaphylactic reactions can occur. Aseptic meningitis syndrome reported with intravenous immune globulin administration (rare). Intravenous immune globulin associated with antiglobulin hemolysis. Hyperproteinemia, increased serum viscosity, and hyponatremia might occur. Infusion reactions (chills, fever, nausea, vomiting, and rarely shock) possible. Transfusion-related acute lung injury noncardiogenic pulmonary edema reported with intravenous immune globulin use. Acute renal dysfunction (acute renal failure, increased serum creatinine, oliguria, osmotic nephrosis) can occur (rarely). Use with caution in the elderly, in renal disease, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and nephrotoxic medications due to risk of renal dysfunction. Thrombotic events reported with administration of intravenous immune globulin (use with caution in history of atherosclerosis or cardiovascular and/or thrombotic risk factors or known/suspected hyperviscosity). High-dose regimens (1000 mg/kg for 1-2 days) not recommended for individuals with fluid overload or where fluid volume may be of concern. Patients should not be volume depleted prior to initiation of therapy. Use with caution in the elderly. Product of human plasma. Packaging of some products may contain natural latex/ rubber. Some products may contain stabilizer L-proline (contraindicated in hyperprolinemia), maltose (may result in falsely-elevated blood glucose readings), sorbitol (avoid use in fructose intolerance), or sucrose. For I.V. administration only. Response to live vaccinations may be impaired.