Padcev Dosage/Direction for Use

Treatment with PADCEV should be initiated and supervised by a physician experienced in the use of anti-cancer therapies. Ensure good venous access prior to starting treatment (see Precautions).
Posology: 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. (See Table 2.)

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Dose modifications: See Table 3.

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Special populations: Elderly: No dose adjustment is necessary in patients ≥65 years of age (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is necessary in patients with mild [creatinine clearance (CrCL) >60-90 mL/min], moderate (CrCL 30-60 mL/min) or severe (CrCL 15-<30 mL/min) renal impairment. Enfortumab vedotin has not been evaluated in patients with end stage renal disease (CrCL <15 mL/min) (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment [total bilirubin of 1 to 1.5 × upper limit of normal (ULN) and AST any, or total bilirubin ≤ ULN and AST > ULN]. Enfortumab vedotin has only been evaluated in a limited number of patients with moderate hepatic impairment and has not been evaluated in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: There is no relevant use of enfortumab vedotin in the paediatric population for the indication of locally advanced or metastatic urothelial cancer.
Method of administration: PADCEV is for intravenous use. 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.
For instructions on reconstitution and dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.