{ "query": "enfortumab vedotin", "ingredient": "enfortumab", "slug": "enfortumab", "rxcui": "2268307", "brands": [ "Padcev" ], "names": [ "enfortumab", "enfortumab vedotin", "enfortumab vedotin-ejfv" ], "classes": [], "alternatives": [], "label": { "route_mode": "INTRAVENOUS", "route_counts": { "INTRAVENOUS": 1 }, "boxed_warning": "WARNING: SERIOUS SKIN REACTIONS \u2022 PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. \u2022 Closely monitor patients for skin reactions. \u2022 Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. \u2022 Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )]. WARNING: SERIOUS SKIN REACTIONS See full prescribing information for complete boxed warning. \u2022 PADCEV can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). \u2022 Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. \u2022 Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. ( 2.2 ), ( 5.1 ), ( 6.1 )", "indications_and_usage": "\u00ae , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). PADCEV \u00ae , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). PADCEV, as a single agent, is indicated for the treatment of adult patients with la/mUC who: \u2022 have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or \u2022 are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated: \u2022 in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1 ) \u2022 in combination wit...", "contraindications": "None. None. ( 4 )", "warnings_and_cautions": "\u2022 Hyperglycemia: Diabetic ketoacidosis may occur in patients with and without preexisting diabetes mellitus, which may be fatal. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. Withhold PADCEV if blood glucose is >250 mg/dL. ( 2.2 , 5.2 ) \u2022 Pneumonitis/Interstitial Lung Disease (ILD): Severe, life-threatening or fatal pneumonitis/ILD may occur. Withhold PADCEV for Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV for Grade 3 or 4 pneumonitis/ILD. ( 2.2 , 5.3 ) \u2022 Peripheral Neuropathy: Monitor patients for new or worsening peripheral neuropathy and consider dose interruption, dose reduction, or discontinuation of PADCEV. ( 2.2 , 5.4 ) \u2022 Ocular Disorders: Ocular disorders, including vision changes, may occur. Monitor patients for signs or symptoms of ocular disorders. Consider prophylactic artificial tears for dry eyes and treatment with ophthalmic topical steroids after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV when symptomatic ocular disorders occur. ( 5.5 ) \u2022 Infusion Site Extravasation: Ensure adequate venous access prior to administration. Monitor the inf...", "warnings": "", "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: \u2022 Skin Reactions [see Boxed Warning , Warnings and Precautions ( 5.1 )] \u2022 Hyperglycemia [see Warnings and Precautions ( 5.2 )] \u2022 Pneumonitis/Interstitial Lung Disease (ILD) [see Warnings and Precautions ( 5.3 )] \u2022 Peripheral Neuropathy [see Warnings and Precautions ( 5.4 )] \u2022 Ocular Disorders [see Warnings and Precautions ( 5.5 )] \u2022 Infusion Site Extravasation [see Warnings and Precautions ( 5.6 )] The most common adverse reactions, including laboratory abnormalities, (\u226520%) were: \u2022 PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC: decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, rash, increased creatinine, decreased lymphocytes, fatigue, pruritus, decreased sodium, peripheral neuropathy, increased potassium, diarrhea, alopecia, dysgeusia, decreased appetite, nausea, constipation, urinary tract infection, dry eye, increased glucose, decreased weight, decreased potassium, hyperglycemia, decreased phosphate, and decreased neutrophils. ( 6.1 ) \u2022 PADCEV in combination with intravenous pembrolizumab for the treatment of la/mUC: inc...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Indications and Usage ( 1 ) 07/2026 Dosage and Administration ( 2.1 ) 07/2026 Warnings and Precautions ( 5.1 ), ( 5.3 ), ( 5.4 ) 07/2026", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Skin Reactions Inform patients that severe skin reactions including SJS and TEN with fatal outcomes have occurred after administration of PADCEV, predominantly during the first cycle of treatment but may occur later. Advise patients to contact their healthcare provider immediately if they develop new target lesions, progressively worsening skin reactions, severe blistering, or peeling of the skin [see Boxed Warning and Warnings and Precautions ( 5.1 )]. Hyperglycemia Inform patients about the risk of hyperglycemia and how to recognize associated symptoms [see Warnings and Precautions ( 5.2 )] . Pneumonitis/ILD Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions ( 5.3 )]. Peripheral Neuropathy Inform patients to report to their healthcare provider any numbness and tingling of the hands or feet or muscle weakness [see Warnings and Precautions ( 5.4 )]. Ocular disorders Advise patients to contact their healthcare provider if they experience any visual changes [see Warnings and Precautions ( 5.5 )] . In order to prevent or treat dry eyes, advise pati...", "spl_medguide": "", "clinical_studies": "14.1 Urothelial Cancer Neoadjuvant and Adjuvant Treatment of Patients with MIBC Who Are Cisplatin-Eligible EV-304 The efficacy of PADCEV in combination with intravenous pembrolizumab as neoadjuvant treatment and then continued after radical cystectomy (RC) as adjuvant treatment was evaluated in EV-304 (NCT04700124), an open-label, randomized, active-controlled, multicenter trial that enrolled patients with previously untreated MIBC with predominant urothelial carcinoma histology and who were candidates for RC with pelvic lymph node dissection (PLND) and were eligible for cisplatin-based chemotherapy. The study excluded patients with primary non-bladder (i.e., ureter, urethral, or renal pelvis) cancer of the urothelium and those with active autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression. Randomization was stratified by tumor stage (T2N0 vs T3/T4aN0 vs T1-T4aN1), PD-L1 combined positive score (CPS \u226510 vs CPS <10), and geographic region (United States vs European Union vs Rest of World). Patients were randomized 1:1 to receive: \u2022 Neoadjuvant PADCEV 1.25 mg/kg as an intravenous infusion on Days 1 and ...", "brand_name": "PADCEV EJFV", "manufacturer": "SEAGEN INC.", "application_number": "BLA761137", "pharm_class_epc": [], "route": [ "INTRAVENOUS" ], "effective_time": "20260804", "set_id": "b5631d3e-4604-4363-8f20-11dfc5a4a8ed", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 7461, "serious": 6571, "death": 1495, "hospitalization": 2591, "primary_suspect": 7454, "top_reactions": [ [ "Rash", 975 ], [ "Neuropathy Peripheral", 875 ], [ "Malignant Neoplasm Progression", 849 ], [ "Diarrhoea", 500 ], [ "Fatigue", 449 ], [ "Pruritus", 443 ], [ "Death", 431 ], [ "Decreased Appetite", 422 ], [ "Off Label Use", 365 ], [ "Alopecia", 330 ], [ "Nausea", 301 ], [ "Pyrexia", 296 ], [ "Skin Disorder", 287 ], [ "Hyperglycaemia", 273 ], [ "Taste Disorder", 251 ] ], "by_year": { "2019": 1, "2020": 277, "2021": 376, "2022": 897, "2023": 972, "2024": 1087, "2025": 2595, "2026": 1254 }, "by_year_primary": { "2019": 1, "2020": 277, "2021": 376, "2022": 895, "2023": 972, "2024": 1087, "2025": 2593, "2026": 1251 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 1, "nda": 0, "anda": 0, "first_approval": "20191218", "rems": false, "rems_last": "", "labeling_supplements": 0, "labeling_recent": 0, "sponsors": [ "ASTELLAS" ], "unapproved": false, "first_approval_fmt": "12/18/2019" }, "trials": { "total": 108, "completed": 10, "terminated": 5, "with_results": 9, "industry": 62, "phase3": 13, "results_share": 0.9, "terminated_share": 0.046296296296296294 }, "pubmed": { "rct": 16, "meta": 9, "recent_rct": 15, "cochrane": [] }, "payments": { "year": "2024", "usd": 1578744.91, "records": 9675, "by_name": [ [ "Padcev", 1578744.91 ] ], "names_checked": [ "enfortumab", "Padcev" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 381, "beneficiaries": 75, "spend": 9438057.92, "by_brand": [ { "brand": "Padcev", "claims": 381, "per_claim": 24771.805564, "is_generic": false } ], "per_claim": 24771.80556430446 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 62, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "Death appears in 2.2x the share of reports seen across all of FAERS (-8)" ], "weight": 0.35 }, "evidence": { "score": 41, "letter": "F", "why": [ "16 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)" ], "weight": 0.25 }, "regulatory": { "score": 95, "letter": "A", "why": [ "No recalls on record since 2016", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 70, "letter": "C", "why": [ "Pharma paid doctors $1,578,745 tied to this drug last year (-30)", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 40, "letter": "F", "why": [ "No generic version approved: brand-only pricing (-30)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 61, "grade": "D", "questions": [ "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "The most-reported problems in FDA's adverse event data are rash, neuropathy peripheral, malignant neoplasm progression, diarrhoea. How would we recognize and handle those?", "There is no generic. Is there an older generic in the same class that works as well for my situation?", "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }