{"id":"digoxin-immune-fab","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypokalemia"},{"rate":null,"effect":"Allergic reactions (rash, fever)"},{"rate":null,"effect":"Worsening heart failure (due to loss of digoxin inotropic effect)"},{"rate":null,"effect":"Serum sickness"}]},"_chembl":null,"_dailymed":{"setId":"c05ee6a5-c98b-45f4-83fd-40781639d653","title":"DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Digoxin immune fab consists of antigen-binding fragments derived from sheep antibodies raised against digoxin. These fragments have high affinity for digoxin and its metabolites, sequestering the drug in the bloodstream and preventing its interaction with Na+/K+-ATPase in cardiac and renal tissues. The digoxin-fab complexes are then eliminated via the kidneys, rapidly reversing digoxin toxicity.","oneSentence":"Digoxin immune fab binds to and neutralizes circulating digoxin, preventing its toxic effects by forming inactive complexes that are renally eliminated.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:44:44.735Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Digoxin toxicity or overdose"},{"name":"Life-threatening digoxin toxicity with arrhythmias or hyperkalemia"}]},"trialDetails":[{"nctId":"NCT03810417","phase":"PHASE4","title":"Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2019-07-22","conditions":"Acute Kidney Injury","enrollment":267},{"nctId":"NCT03008616","phase":"PHASE2, PHASE3","title":"Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia","status":"TERMINATED","sponsor":"AMAG Pharmaceuticals, Inc.","startDate":"2017-04-12","conditions":"Severe Preeclampsia","enrollment":59},{"nctId":"NCT01328600","phase":"","title":"Marinobufagenin as a Target for DIGIBIND in Preeclampsia","status":"COMPLETED","sponsor":"National Institute on Aging (NIA)","startDate":"2006-08-16","conditions":"Preeclampsia","enrollment":144},{"nctId":"NCT00158743","phase":"PHASE2","title":"Efficacy Study of Digibind for Treatment of Severe Preeclampsia","status":"COMPLETED","sponsor":"BTG International Inc.","startDate":"2004-02","conditions":"Pre-eclampsia","enrollment":51},{"nctId":"NCT00550576","phase":"PHASE2","title":"Antibodies to Digoxin for Bipolar Disorder","status":"COMPLETED","sponsor":"Rambam Health Care Campus","startDate":"2007-10","conditions":"Bipolar Disorder","enrollment":18},{"nctId":"NCT00852787","phase":"PHASE4","title":"Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease","status":"UNKNOWN","sponsor":"National Institute on Aging (NIA)","startDate":"2009-04","conditions":"Hypertension, Hemodialysis","enrollment":30}],"_emaApprovals":[],"_faersSignals":[{"count":5,"reaction":"DRUG INEFFECTIVE"},{"count":2,"reaction":"ACUTE KIDNEY INJURY"},{"count":2,"reaction":"TOXICITY TO VARIOUS AGENTS"},{"count":1,"reaction":"ABDOMINAL PAIN"},{"count":1,"reaction":"ABDOMINAL WALL HAEMATOMA"},{"count":1,"reaction":"BONE DENSITY DECREASED"},{"count":1,"reaction":"CALCIUM DEFICIENCY"},{"count":1,"reaction":"CARDIAC FAILURE CONGESTIVE"},{"count":1,"reaction":"DEATH"},{"count":1,"reaction":"DIARRHOEA"}],"_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":["Digibind"],"phase":"marketed","status":"active","brandName":"Digoxin immune fab","genericName":"Digoxin immune fab","companyName":"National Institute on Aging (NIA)","companyId":"national-institute-on-aging-nia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Digoxin immune fab binds to and neutralizes circulating digoxin, preventing its toxic effects by forming inactive complexes that are renally eliminated. Used for Digoxin toxicity or overdose, Life-threatening digoxin toxicity with arrhythmias or hyperkalemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}