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 Padcev as a single agent 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.
When given in combination with pembrolizumab, the recommended dose of Padcev 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 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. Refer to the pembrolizumab Prescribing Information for the recommended dosing information of pembrolizumab.
Refer to Table 4 for Recommended Dose Reduction Schedule for Adverse Events for Padcev. (See Table 4.)

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Dose Modifications: See Table 5.

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Special Populations: Elderly: No dose adjustment is required in patients ≥65 years of age (see Pharmacology: Pharmacokinetics under Actions).
Patients with Renal Impairment: No dose adjustment is required 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 (see Pharmacology: Pharmacokinetics under Actions).
Enfortumab vedotin has not been evaluated in patients with end stage renal disease.
Patients with Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment [total bilirubin of 1 to 1.5 x 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).
Pediatric population: There is no relevant use of enfortumab vedotin in the paediatric population for the indication of locally advanced or metastatic urothelial cancer. The safety and efficacy of enfortumab vedotin in pediatric patients have not been established.
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 under Cautions for Usage.