{"id":"ignextgen-10","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Thrombosis"},{"rate":null,"effect":"Renal dysfunction"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a 10% concentration IVIG, this product contains polyvalent human immunoglobulins (primarily IgG) derived from pooled plasma donations. It works through multiple mechanisms including antibody replacement in immunodeficiency states, immune modulation via Fc receptor engagement, and neutralization of pathogenic antibodies and antigens. The higher 10% concentration allows for smaller infusion volumes compared to lower-concentration formulations.","oneSentence":"IgNextGen 10% is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:48:16.003Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency"},{"name":"Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)"}]},"trialDetails":[{"nctId":"NCT00362349","phase":"PHASE3","title":"Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients","status":"COMPLETED","sponsor":"CSL Limited","startDate":"2007-06","conditions":"Idiopathic Thrombocytopenic Purpura (ITP)","enrollment":19}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4431360,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"IgNextGen 10%","genericName":"IgNextGen 10%","companyName":"CSL Limited","companyId":"csl-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"IgNextGen 10% is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}