{"id":"privigen-csl-behring","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Thromboembolism"},{"rate":null,"effect":"Aseptic meningitis"},{"rate":null,"effect":"Acute kidney injury"}]},"_chembl":null,"_fixedAt":"2026-03-30T14:27:23.085670","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PRIVIGEN contains polyvalent immunoglobulin G (IgG) derived from pooled human plasma, which provides immediate passive immunity and helps regulate aberrant immune responses. It works through multiple mechanisms including antibody replacement in immunodeficiency states, immune modulation via Fc receptor engagement, and neutralization of pathogenic autoantibodies and cytokines in autoimmune and inflammatory conditions.","oneSentence":"PRIVIGEN is an intravenous immunoglobulin (IVIg) that provides passive immunity by supplying pooled human antibodies to modulate immune responses and replace deficient immunoglobulins.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:36:35.679Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency syndromes"},{"name":"Secondary immunodeficiency in hematologic malignancies"},{"name":"Chronic inflammatory demyelinating polyneuropathy (CIDP)"},{"name":"Multifocal motor neuropathy (MMN)"},{"name":"Immune thrombocytopenia (ITP)"},{"name":"Post-transfusion purpura"},{"name":"Autoimmune hemolytic anemia"}]},"_fixedFields":["pubmed(34)"],"trialDetails":[{"nctId":"NCT02899702","phase":"PHASE4","title":"Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children","status":"WITHDRAWN","sponsor":"Hospices Civils de Lyon","startDate":"2020-09","conditions":"Staphylococcal Infection, Streptococcal Infection","enrollment":""},{"nctId":"NCT02374736","phase":"PHASE3","title":"Effect of Privigen Against Graft Loss","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2016-02-05","conditions":"Kidney Transplantation","enrollment":18},{"nctId":"NCT00722475","phase":"PHASE3","title":"Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2008-08","conditions":"Secondary Recurrent Miscarriage","enrollment":82}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":34,"recentPublications":[{"date":"2025 Jun 1","pmid":"39909490","title":"A phase 2 randomized trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis.","journal":"Rheumatology (Oxford, England)"},{"date":"2024 Nov","pmid":"39291857","title":"Outcomes of a patient support programme for subcutaneous immunoglobulin therapy in patients with primary or secondary immunodeficiencies or chronic inflammatory demyelinating polyneuropathy.","journal":"Internal medicine journal"},{"date":"2023 Aug","pmid":"37453363","title":"Low and high serum IgG associates with respiratory infections in a young and working age population.","journal":"EBioMedicine"},{"date":"2022 May 14","pmid":"35567293","title":"Case Series of Successful Intravenous Immunoglobulin (IVIG) Treatment in 4 Pregnant Patients with Severe COVID-19-Induced Hypoxia.","journal":"The American journal of case reports"},{"date":"2021","pmid":"35111165","title":"Replacement and Immunomodulatory Activities of 20% Subcutaneous Immunoglobulin Treatment: A Single-Center Retrospective Study in Autoimmune Myositis and CVID Patients.","journal":"Frontiers in immunology"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"PRIVIGEN (CSL Behring)","genericName":"PRIVIGEN (CSL Behring)","companyName":"Hospices Civils de Lyon","companyId":"hospices-civils-de-lyon","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PRIVIGEN is an intravenous immunoglobulin (IVIg) that provides passive immunity by supplying pooled human antibodies to modulate immune responses and replace deficient immunoglobulins. Used for Primary immunodeficiency syndromes, Secondary immunodeficiencies (e.g., chronic lymphocytic leukemia, HIV infection), 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}}