PADCEV® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/VIAL

ASTELLAS PHARMA SINGAPORE PTE. LTD.

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**4.2 Posology and method of administration** Treatment with Padcev should be initiated and supervised by a physician experienced in the use of anti-cancer therapies. Posology 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, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.  _Dose Modifications_  Special Populations _Elderly_ No dose adjustment is necessary in patients ≥65 years of age (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Patients with 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 <30 mL/min) renal impairment (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Patients with Hepatic Impairment_ No dose adjustment is necessary in patients with mild hepatic impairment (bilirubin of 1 to 1.5 × ULN and AST < ULN, or bilirubin ≤ ULN and AST > ULN). Padcev is not recommended in patients with moderate or severe hepatic impairment (AST or ALT >2.5 × ULN or total bilirubin >1.5 × ULN) as there is limited to no safety and efficacy in these patient populations (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ There is no relevant use of Padcev in the paediatric population for the indication of LA or mUC. Method of administration The recommended dose of Padcev must be administered by intravenous infusion over 30 minutes. Padcev must not be administered as an intravenous push or bolus injection. For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.