{"id":"ignextgen-16","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Infusion site reactions"},{"rate":null,"effect":"Thromboembolism"},{"rate":null,"effect":"Renal dysfunction"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a 16% concentration IVIG, this product contains immunoglobulins (primarily IgG) derived from pooled human plasma. It works by providing immediate passive immunity, neutralizing pathogens and toxins, modulating inflammatory responses through Fc receptor engagement, and supporting patients with immunodeficiency or autoimmune conditions. The higher 16% concentration allows for smaller infusion volumes compared to standard IVIG formulations.","oneSentence":"IgNextGen 16% is an intravenous immunoglobulin (IVIG) product that provides passive immunization by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:36.165Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency"},{"name":"Autoimmune and inflammatory conditions"}]},"trialDetails":[{"nctId":"NCT00391131","phase":"PHASE3","title":"Subcutaneous Ig NextGen 16% in PID Patients","status":"COMPLETED","sponsor":"CSL Limited","startDate":"2007-04","conditions":"Primary Immunodeficiency (PID)","enrollment":35}],"_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":[],"phase":"phase_3","status":"active","brandName":"IgNextGen 16%","genericName":"IgNextGen 16%","companyName":"CSL Limited","companyId":"csl-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"IgNextGen 16% is an intravenous immunoglobulin (IVIG) product that provides passive immunization by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}