{"id":"igiv-gammagard-liquid-kiovig","safety":{"commonSideEffects":[{"rate":"5-15","effect":"Headache"},{"rate":"5-10","effect":"Fever"},{"rate":"5-10","effect":"Chills"},{"rate":"5-10","effect":"Fatigue"},{"rate":"5-10","effect":"Myalgia"},{"rate":"3-8","effect":"Nausea"},{"rate":"2-5","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":"IGIV is a preparation of concentrated immunoglobulin G (IgG) derived from pooled human plasma that contains a broad spectrum of antibodies against common pathogens. It works by providing immediate passive immunity, opsonizing pathogens, activating complement, and modulating immune responses through Fc receptor engagement. This helps prevent infections in immunocompromised patients and can suppress pathogenic autoimmune responses in certain conditions.","oneSentence":"IGIV (intravenous immunoglobulin) provides passive immunity by supplying pooled human antibodies to replace or supplement deficient or dysfunctional immunoglobulin in patients with immune deficiencies or autoimmune conditions.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:15:35.178Z","_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"},{"name":"Idiopathic thrombocytopenic purpura (ITP)"},{"name":"Post-transfusion purpura"},{"name":"Kawasaki disease"}]},"trialDetails":[{"nctId":"NCT06980480","phase":"PHASE3","title":"A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma","status":"RECRUITING","sponsor":"Takeda","startDate":"2026-01-14","conditions":"Multiple Myeloma, Secondary Immunodeficiency","enrollment":183},{"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":"NCT00666263","phase":"PHASE3","title":"Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2008-08-22","conditions":"Multifocal Motor Neuropathy","enrollment":50},{"nctId":"NCT00818662","phase":"PHASE3","title":"A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2008-12-19","conditions":"Alzheimer´s Disease","enrollment":390},{"nctId":"NCT01175213","phase":"PHASE3","title":"Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2010-07-28","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":66},{"nctId":"NCT00814320","phase":"PHASE3","title":"Gammagard Liquid and rHuPH20 in PID","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2008-12-18","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":89},{"nctId":"NCT01412385","phase":"PHASE2, PHASE3","title":"Immune Globulin Subcutaenous (Human), 20%","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2011-06-20","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":55},{"nctId":"NCT01951924","phase":"PHASE3","title":"LIME Study (LFB IVIg MMN Efficacy Study)","status":"COMPLETED","sponsor":"Laboratoire français de Fractionnement et de Biotechnologies","startDate":"2013-12","conditions":"Motor Neuron Disease","enrollment":23}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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","10% (GAMMAGARD LIQUID/KIOVIG)","GAMMAGARD LIQUID"],"phase":"phase_3","status":"active","brandName":"IGIV GAMMAGARD LIQUID/KIOVIG","genericName":"IGIV GAMMAGARD LIQUID/KIOVIG","companyName":"Baxalta now part of Shire","companyId":"baxalta-now-part-of-shire","modality":"Biologic","firstApprovalDate":"","aiSummary":"IGIV (intravenous immunoglobulin) provides passive immunity by supplying pooled human antibodies to replace or supplement deficient or dysfunctional immunoglobulin in patients with immune deficiencies or autoimmune conditions. 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":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}