{"id":"igiv-gamunex-c","safety":{"commonSideEffects":[{"rate":"5-15%","effect":"Headache"},{"rate":"5-10%","effect":"Fever"},{"rate":"5-10%","effect":"Chills"},{"rate":"5-10%","effect":"Fatigue"},{"rate":"3-8%","effect":"Nausea"},{"rate":"5-10%","effect":"Infusion site reactions"},{"rate":"<1%","effect":"Aseptic meningitis"},{"rate":"<1%","effect":"Thromboembolism"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Gamunex-C contains immunoglobulin G (IgG) antibodies derived from pooled human plasma that provide immediate passive immunity against pathogens. It works by replacing deficient or dysfunctional antibodies in immunocompromised patients and can modulate inflammatory immune responses through multiple mechanisms including Fc receptor engagement and complement inhibition. The formulation is stabilized with maltose and is administered intravenously to treat primary immunodeficiency disorders and certain autoimmune/inflammatory conditions.","oneSentence":"IGIV Gamunex-C is an intravenous immunoglobulin (IVIG) that provides passive immunity by supplying pooled human antibodies to help patients fight infections and modulate immune responses.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:48:16.038Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, common variable immunodeficiency)"},{"name":"Secondary immunodeficiency in hematologic malignancies"},{"name":"Chronic inflammatory demyelinating polyneuropathy (CIDP)"},{"name":"Multifocal motor neuropathy (MMN)"}]},"trialDetails":[{"nctId":"NCT02205762","phase":"PHASE2, PHASE3","title":"LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis","status":"RECRUITING","sponsor":"North American Consortium for Histiocytosis","startDate":"2016-11-02","conditions":"Langerhans Cell Histiocytosis","enrollment":1400},{"nctId":"NCT01019876","phase":"PHASE2, PHASE3","title":"Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases","status":"COMPLETED","sponsor":"Columbia University","startDate":"2002-09","conditions":"Bone Marrow Failure, Osteopetrosis, Fanconi Anemia","enrollment":38},{"nctId":"NCT02549170","phase":"PHASE3","title":"A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2015-12-15","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy","enrollment":138},{"nctId":"NCT01854827","phase":"PHASE1, PHASE2","title":"Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia","status":"COMPLETED","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","startDate":"2013-10","conditions":"Biliary Atresia","enrollment":30},{"nctId":"NCT01804829","phase":"PHASE3","title":"Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.","status":"COMPLETED","sponsor":"Biotest Pharmaceuticals Corporation","startDate":"2013-06","conditions":"Hepatitis C Infection, Viruses, Hepatocellular Carcinoma","enrollment":80},{"nctId":"NCT00220727","phase":"PHASE2","title":"Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2003-07","conditions":"Purpura, Thrombocytopenic, Idiopathic","enrollment":8},{"nctId":"NCT00220779","phase":"PHASE2","title":"Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2002-12","conditions":"Multiple Sclerosis, Relapsing-Remitting","enrollment":128},{"nctId":"NCT00220740","phase":"PHASE3","title":"Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2004-04","conditions":"Polyradiculoneuropathy, Chronic Inflammatory Demyelinating","enrollment":117},{"nctId":"NCT00220805","phase":"PHASE2","title":"Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2004-01","conditions":"Macular Degeneration","enrollment":96},{"nctId":"NCT00389324","phase":"PHASE2","title":"A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2006-11","conditions":"Immunologic Deficiency Syndrome","enrollment":35},{"nctId":"NCT01465958","phase":"PHASE4","title":"Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2011-11","conditions":"Primary Immunodeficiency","enrollment":12}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Immune Globulin Infusion (Human)","Intravenous immunoglobulin G","Approved IGIV product for US sites"],"phase":"phase_3","status":"active","brandName":"IGIV GAMUNEX®-C","genericName":"IGIV GAMUNEX®-C","companyName":"Baxalta now part of Shire","companyId":"baxalta-now-part-of-shire","modality":"Biologic","firstApprovalDate":"","aiSummary":"IGIV Gamunex-C is an intravenous immunoglobulin (IVIG) that provides passive immunity by supplying pooled human antibodies to help patients fight infections and modulate immune responses. Used for Primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, common variable immunodeficiency), Secondary immunodeficiency in hematologic malignancies, Chronic inflammatory demyelinating polyneuropathy (CIDP).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}