Active Ingredient: Enfortumab vedotin
Enfortumab vedotin 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, between 1.25 milligrams enfortumab vedotin per kilogram of body weight and 125 milligrams enfortumab vedotin per kilogram of body weight, once every 7 days. The maximum allowed total dose is 125 milligrams enfortumab vedotin per kilogram of body weight every 7 days.
The recommended dose of enfortumab vedotin is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Table 1. Recommended dose reductions for adverse reactions:
| Dose level | |
|---|---|
| Starting dose | 1.25 mg/kg up to 125 mg |
| First dose reduction | 1.0 mg/kg up to 100 mg |
| Second dose reduction | 0.75 mg/kg up to 75 mg |
| Third dose reduction | 0.5 mg/kg up to 50 mg |
Table 2. Dose interruption, reduction and discontinuation of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer:
| Adverse reaction | Severity* | Dose modification* |
|---|---|---|
| Skin reactions | Suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (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 | • Withhold until Grade ≤1 • Referral to specialised care should be considered • Resume at the same dose level or consider dose reduction by one dose level (see Table 1) | |
| Hyperglycaemia | Blood glucose >13.9 mmol/L (>250 mg/dL) | • Withhold until elevated blood glucose has improved to ≤13.9 mmol/L (≤250 mg/dL) • Resume treatment at the same dose level |
| Pneumonitis/ interstitial lung disease (ILD) | Grade 2 | • Withhold until Grade ≤1, then resume at the same dose or consider dose reduction by one dose level (see Table 1). |
| Grade ≥3 | Permanently discontinue. | |
| Peripheral neuropathy | Grade 2 | • Withhold until Grade ≤1 • For first occurrence, resume treatment at the same dose level • For a recurrence, withhold until Grade ≤1 then, resume treatment reduced by one dose level (see Table 1) |
| Grade ≥3 | Permanently discontinue. |
* Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) where Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe and Grade 4 is life-threatening.
The recommended dose must be administered by intravenous infusion over 30 minutes. Enfortumab vedotin must not be administered as an intravenous push or bolus injection.
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