{"id":"iv-treatment-with-igsc-10","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Thrombosis (rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This product contains immunoglobulin G (IgG) antibodies derived from pooled human plasma, administered intravenously at 10% concentration. It works by providing immediate passive immunity, neutralizing pathogens, and modulating immune responses through Fc receptor engagement and complement activation. It is used to treat primary immunodeficiencies and certain secondary immune conditions.","oneSentence":"IGSC 10% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to help regulate immune function and fight infections.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:17:30.260Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, common variable immunodeficiency)"},{"name":"Secondary immunodeficiencies"},{"name":"Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)"}]},"trialDetails":[{"nctId":"NCT01218438","phase":"PHASE2, PHASE3","title":"Phase 2/3 Study of IGSC, 20% in PIDD","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2013-01-28","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":86},{"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}],"_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":["GAMMAGARD LIQUID (US)","KIOVIG (EU)"],"phase":"phase_3","status":"active","brandName":"IV treatment with IGSC, 10%","genericName":"IV treatment with IGSC, 10%","companyName":"Baxalta now part of Shire","companyId":"baxalta-now-part-of-shire","modality":"Biologic","firstApprovalDate":"","aiSummary":"IGSC 10% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to help regulate immune function and fight infections. Used for Primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, common variable immunodeficiency), Secondary immunodeficiencies, Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}