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The recommended dose of PADCEV as a single agent is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an IV infusion over 30 minutes on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity.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
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; PD-1 - programmed death receptor-1; PD-L1 - programmed death-ligand 1; 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.
