{"id":"beriplex-p-n-kcentra","safety":{"commonSideEffects":[{"rate":null,"effect":"Thromboembolism (venous thromboembolism, myocardial infarction, stroke)"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Disseminated intravascular coagulation (DIC)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Beriplex P/N contains concentrated human plasma-derived clotting factors II, VII, IX, and X (the vitamin K-dependent factors). It is used to quickly restore coagulation capacity in patients who are over-anticoagulated with warfarin and require urgent reversal, such as in cases of life-threatening bleeding or before emergency surgery. The product works by directly replenishing the depleted clotting factors that warfarin inhibits.","oneSentence":"Beriplex P/N is a prothrombin complex concentrate that replaces deficient vitamin K-dependent clotting factors to rapidly reverse warfarin anticoagulation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:04:05.057Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Urgent reversal of warfarin anticoagulation in patients with life-threatening bleeding"},{"name":"Reversal of warfarin anticoagulation in patients requiring emergency surgery or urgent procedures"}]},"trialDetails":[{"nctId":"NCT02740335","phase":"PHASE3","title":"Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.","status":"COMPLETED","sponsor":"Octapharma","startDate":"2017-06-08","conditions":"Significant Bleeding Risk","enrollment":208},{"nctId":"NCT00803101","phase":"PHASE3","title":"An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2009-02","conditions":"Reversal of Coagulopathy","enrollment":176},{"nctId":"NCT00708435","phase":"PHASE3","title":"Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2008-06","conditions":"Blood Coagulation Disorders, Acute Major Bleeding","enrollment":216}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Kcentra"],"phase":"phase_3","status":"active","brandName":"Beriplex® P/N (Kcentra)","genericName":"Beriplex® P/N (Kcentra)","companyName":"CSL Behring","companyId":"csl-behring","modality":"Biologic","firstApprovalDate":"","aiSummary":"Beriplex P/N is a prothrombin complex concentrate that replaces deficient vitamin K-dependent clotting factors to rapidly reverse warfarin anticoagulation. Used for Urgent reversal of warfarin anticoagulation in patients with life-threatening bleeding, Reversal of warfarin anticoagulation in patients requiring emergency surgery or urgent procedures.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}