Padcev (enfortumab vedotin-ejfv)

Black Box Warnings .

Adult Dosing .

Dosage forms:  INJ

Special Note

[drug name 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 including toxicity-related dose adjustments

[dosing clarification]

Info: for patients >100 kg, cap wt at 100 kg for dose calculations

urothelial carcinoma

[muscle invasive bladder CA]

Dose: 1.25 mg/kg/dose IV x1 on days 1, 8 of 21-day cycle; Max: 125 mg/dose; Info: for patients ineligible for cisplatin-containing chemo; use with pembrolizumab or pembrolizumab/berahyaluronidase alfa; give x3 cycles in neoadjuvant setting, then x6 cycles in adjuvant setting

[locally advanced or metastatic disease, combo tx]

Dose: 1.25 mg/kg/dose IV x1 on days 1, 8 of 21-day cycle; Max: 125 mg/dose; Info: use with pembrolizumab or pembrolizumab/berahyaluronidase alfa

[locally advanced or metastatic disease, monotherapy]

Dose: 1.25 mg/kg/dose IV x1 on days 1, 8, 15 of 28-day cycle; Max: 125 mg/dose; Info: for patients previously treated with PD-1/PD-L1 inhibitor and platinum-containing chemo or cisplatin-ineligible patients who have received at least 1 prior tx

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.