Active Ingredient: Enfortumab vedotin
Enfortumab vedotin, 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
From cycle 1 and thereafter :
Intravenous, 1.25 milligrams enfortumab vedotin per kilogram of body weight, once every 7 days, 2 doses in total, over the duration of 21 days.
Table 1. Recommended dose for enfortumab vedotin in combination with pembrolizumab*:
| Indication | Recommended enfortumab vedotin dose | Duration of therapy |
| Unresectable or metastatic urothelial cancer | Enfortumab vedotin 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) on Days 1 and 8 of a 21-day cycle. | Until disease progression or unacceptable toxicity. |
* Patients should be administered pembrolizumab after enfortumab vedotin when given on the same day. Refer to the pembrolizumab SmPC for additional dosing information of pembrolizumab.
Table 2. Recommended dose reductions of enfortumab vedotin for adverse reactions:
| Dose reduction schedule | 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 3. Dose interruption, reduction and discontinuation of enfortumab vedotin:
| 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 2). | |
| 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 2). |
| 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 2). |
| 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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