{"id":"daratumumab-hyaluronidase-fihj","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Neuropathy"}]},"_chembl":null,"_dailymed":{"setId":"4bb241af-4299-4373-8762-2d6709515db0","title":"DARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)) INJECTION [JANSSEN BIOTECH, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Daratumumab is a monoclonal antibody that targets CD38, a surface antigen highly expressed on multiple myeloma cells, leading to cell death through antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP). The addition of hyaluronidase (fihj) allows for subcutaneous injection with rapid absorption, improving patient convenience compared to intravenous administration while maintaining the same mechanism of action.","oneSentence":"Daratumumab binds to CD38 on multiple myeloma cells to trigger their destruction, while hyaluronidase enables faster subcutaneous administration by breaking down hyaluronic acid in tissue.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T05:01:34.934Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multiple myeloma (newly diagnosed and relapsed/refractory)"},{"name":"Light chain myeloma"}]},"trialDetails":[{"nctId":"NCT06169215","phase":"PHASE2","title":"Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-07-23","conditions":"Multiple Myeloma","enrollment":70},{"nctId":"NCT06948084","phase":"PHASE2","title":"Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse","status":"NOT_YET_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-04-29","conditions":"Recurrent Multiple Myeloma, Refractory Multiple Myeloma","enrollment":80},{"nctId":"NCT05807048","phase":"PHASE2","title":"Daratumumab in STK11 Mutated NSCLC","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2023-06-01","conditions":"Non-small Cell Lung Cancer With STK11/LKB1 Mutation","enrollment":8},{"nctId":"NCT06192979","phase":"NA","title":"Optimize First-line Treatment for AL Amyloidosis With t (11; 14)","status":"RECRUITING","sponsor":"Jin Lu, MD","startDate":"2024-01-05","conditions":"Amyloidosis; Systemic, AL Amyloidosis","enrollment":41},{"nctId":"NCT04566328","phase":"PHASE3","title":"Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial","status":"RECRUITING","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2021-02-24","conditions":"Plasma Cell Myeloma, RISS Stage I Plasma Cell Myeloma, RISS Stage II Plasma Cell Myeloma","enrollment":1450},{"nctId":"NCT07082270","phase":"PHASE1","title":"Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma","status":"NOT_YET_RECRUITING","sponsor":"Roswell Park Cancer Institute","startDate":"2026-04-01","conditions":"Recurrent Multiple Myeloma, Refractory Multiple Myeloma","enrollment":21},{"nctId":"NCT07247097","phase":"PHASE2","title":"ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma","status":"NOT_YET_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2026-04-15","conditions":"Multiple Myeloma, Newly Diagnosed Multiple Myeloma, Transplant Ineligible","enrollment":160},{"nctId":"NCT05511428","phase":"PHASE4","title":"Home Based Daratumumab Administration for Patients With Multiple Myeloma","status":"COMPLETED","sponsor":"Thomas Jefferson University","startDate":"2022-11-08","conditions":"Plasma Cell Myeloma","enrollment":20},{"nctId":"NCT07110844","phase":"PHASE2","title":"Teclistamab-Daratumumab in AL Amyloidosis","status":"RECRUITING","sponsor":"Suzanne Lentzsch, MD","startDate":"2025-11-07","conditions":"Amyloid Light-chain Amyloidosis","enrollment":25},{"nctId":"NCT05139225","phase":"PHASE1","title":"A Study of TTI-622 in Combination With Daratumumab Hyaluronidase-fihj in People With Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2021-10-28","conditions":"Multiple Myeloma","enrollment":7},{"nctId":"NCT05300451","phase":"PHASE2","title":"Daratumumab in HLA Desensitization Prior to Transplantation","status":"ENROLLING_BY_INVITATION","sponsor":"Barry A. 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Myeloma","enrollment":""}],"_emaApprovals":[],"_faersSignals":[{"count":51,"reaction":"NEUTROPHIL COUNT DECREASED"},{"count":49,"reaction":"PNEUMONIA"},{"count":48,"reaction":"DYSPNOEA"},{"count":44,"reaction":"THERAPY INTERRUPTED"},{"count":40,"reaction":"PYREXIA"},{"count":39,"reaction":"NEUTROPENIA"},{"count":38,"reaction":"FATIGUE"},{"count":38,"reaction":"OFF LABEL USE"},{"count":36,"reaction":"SEPSIS"},{"count":34,"reaction":"PLASMA CELL MYELOMA"}],"_approvalHistory":[],"publicationCount":1,"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":"Daratumumab 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Used for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}