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Padcev (enfortumab vedotin-ejfv)
enfortumab vedotin
Black Box Warnings .
Serious Skin Rxns
incl. fatal cases, occurred predominantly during 1st cycle but may occur later; monitor for skin rxns; withhold tx if suspected Stevens Johnson Syndrome, toxic epidermal necrolysis, or severe skin rxns; permanently D/C tx if confirmed Stevens Johnson Syndrome, toxic epidermal necrolysis, or Grade 4 or recurrent Grade 3 skin rxns
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: nonproprietary name = enfortumab vedotin-ejfv
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments; for pts >100 kg, cap wt at 100 kg for dose calculations
urothelial carcinoma, locally advanced or metastatic
- [monotherapy]
- Dose: 1.25 mg/kg/dose IV x1 on days 1, 8, 15 of 28-day cycle; Max: 125 mg/dose; Info: for pts previously treated w/ PD-1/PD-L1 inhibitor and platinum-containing chemo or cisplatin-ineligible pts who have received at least 1 prior tx
- [combo tx]
- Dose: 1.25 mg/kg/dose IV x1 on days 1, 8 of 21-day cycle; Max: 125 mg/dose; Info: use w/ pembrolizumab
renal dosing
- [see below]
- renal impairment: no adjustment; ESRD: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin >1.5x ULN: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.