{"id":"flebogamma-5-dif","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Infusion site reactions"},{"rate":null,"effect":"Thrombosis"},{"rate":null,"effect":"Aseptic meningitis"}]},"_chembl":{"chemblId":"CHEMBL2074993","moleculeType":"Small molecule","molecularWeight":"385.02"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a human immunoglobulin G (IgG) product derived from pooled plasma of multiple donors, Flebogamma 5% DIF works through multiple mechanisms including antibody replacement in immunodeficiency states, immune modulation via Fc receptor engagement, and neutralization of pathogenic antibodies and antigens. The DIF (Diluent-Free) formulation allows for direct intravenous administration without requiring separate dilution.","oneSentence":"Flebogamma 5% DIF is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses and replace deficient immunoglobulins.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:30:29.621Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency in hematologic malignancies"},{"name":"Idiopathic thrombocytopenic purpura (ITP)"},{"name":"Chronic inflammatory demyelinating polyneuropathy (CIDP)"},{"name":"Multifocal motor neuropathy (MMN)"},{"name":"Post-transfusion purpura"},{"name":"Kawasaki disease"}]},"trialDetails":[{"nctId":"NCT02176863","phase":"PHASE2, PHASE3","title":"Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome","status":"TERMINATED","sponsor":"Instituto Grifols, S.A.","startDate":"2014-09-23","conditions":"Post-polio Syndrome","enrollment":191},{"nctId":"NCT04432324","phase":"PHASE2","title":"Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)","status":"COMPLETED","sponsor":"Instituto Grifols, S.A.","startDate":"2020-06-02","conditions":"COVID-19","enrollment":100},{"nctId":"NCT01561053","phase":"PHASE2, PHASE3","title":"A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease","status":"COMPLETED","sponsor":"Instituto Grifols, S.A.","startDate":"2012-04-19","conditions":"Alzheimer's Disease","enrollment":347},{"nctId":"NCT00634569","phase":"PHASE4","title":"Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects","status":"COMPLETED","sponsor":"Instituto Grifols, S.A.","startDate":"2008-05","conditions":"Primary Immune Deficiency Disease","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"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 intravenous (human)"],"phase":"marketed","status":"active","brandName":"Flebogamma 5% DIF","genericName":"Flebogamma 5% DIF","companyName":"Instituto Grifols, S.A.","companyId":"instituto-grifols-s-a","modality":"Biologic","firstApprovalDate":"","aiSummary":"Flebogamma 5% DIF is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses and replace deficient immunoglobulins. Used for Primary immunodeficiency disorders, Secondary immunodeficiency in hematologic malignancies, Idiopathic thrombocytopenic purpura (ITP).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}