News – Bladder cancer: measures to reduce the risk of serious skin reactions associated with enfortumab vedotin, authorized for early access

Patients should be monitored throughout treatment for the appearance of skin reactions, especially during the first cycle of treatment. The median time to onset of severe skin reactions is around 17 days (range: 0.1 to 6.4 months).

In case of mild to moderate skin reactions, appropriate treatment, such as topical corticosteroids and antihistamines, may be considered.

If Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) is suspected, or if bullous lesions appear, treatment should be discontinued immediately and the patient should be referred to a specialist. Histological confirmation, which may require the performance of several biopsies, is essential to allow diagnosis and early management of severe skin reactions.

In case of worsening grade 2, grade 2 with fever or grade 3 skin reactions, treatment should be withheld until the reaction resolves to ≤ grade 1 and specialist consultation should be considered. The treatment can be resumed at the same dose or at a reduced dose (reduction of one dose level) (see section 4.2 of the SmPC).

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