PADCEV® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/VIAL [SIN16503P]

Product Info

PADCEV® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/VIAL

[SIN16503P]

4.1 Therapeutic indications

Padcev, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).

Padcev, as monotherapy, is indicated for the treatment of adult patients with locally advanced or mUC who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

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

As monotherapy, 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.

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. Patients should be administered pembrolizumab after enfortumab vedotin when given on the same day. Refer to the pembrolizumab Prescribing Information for the recommended dosing information of pembrolizumab.

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 15–<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 (total bilirubin of 1 to 1.5 × ULN and AST any, or total bilirubin ≤ ULN and AST > ULN). Padcev is not recommended in patients with moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and AST any) as there is limited 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 locally advanced or metastatic urothelial cancer.

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.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.