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In the EV-302 trial, on Day 1 of every 21-day cycle, PADCEV dosing was followed by pembrolizumab 200 mg via IV, approximately 30 minutes after completion of PADCEV infusion.* Patients weighing ≥100 kg are subject to a dose cap for PADCEV (up to a maximum dose of 125 mg).1
Refer to the pembrolizumab SmPC for the recommended dosing information of pembrolizumab.1
This suggested dosing differs from treatment with PADCEV alone.1
*Patients should be administered pembrolizumab after PADCEV when given on the same day.1
Dose modifications due to AEs
| Selected adverse event | Severity* | Dose modification* |
|---|---|---|
 Skin reactions | Suspected SJS or TEN or bullous lesions | Immediately withhold and refer to specialised care |
| Confirmed SJS or TEN; Grade 4 or recurrent Grade 3 | Permanently discontinue | |
| Grade 2 worsening Grade 2 with fever Grade 3 |
| |
 Hyperglycaemia | Blood glucose >13.9 mmol/L (>250 mg/dL) |
|
 Pneumonitis/ILD | Grade 2 | Withhold until Grade ≤1, then resume at the same dose or consider dose reduction by one dose level |
| Grade ≥3 | Permanently discontinue | |
 Peripheral neuropathy | Grade 2 |
|
| Grade ≥3 | Permanently discontinue |
PADCEV India Prescribing Information.1
*Toxicity was graded per NCI-CTCAE v5.0, where Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening.1
Consult the full Prescribing Information for appropriate dose modifications related to AEs.
1L – first-line; 2L – second-line; AE – adverse event; ILD – interstitial lung disease; IV – intravenous; MoA – mechanism of action; NCI-CTCAE – National Cancer Institute Common Terminology Criteria for Adverse Events; SJS – Stevens-Johnson syndrome; TEN – toxic epidermal necrolysis; UC – urothelial cancer
References
PADCEV, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.
PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
