Padcev Dosage & Drug Information

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Core Prescribing Info

Contents

Enfortumab vedotin

Indications/Uses

Monotherapy for locally advanced or metastatic urothelial cancer (mUC) in adults who have previously received programmed death receptor-1 or programmed death-ligand 1 inhibitor & platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. In combination w/ pembrolizumab in adults w/ locally advanced or mUC.

Dosage/Direction for Use

IV Infuse over 30 min. Monotherapy Recommended dose: 1.25 mg/kg on days 1, 8 & 15 of 28-day cycle until disease progression or unacceptable toxicity. In combination w/ pembrolizumab Recommended dose: 1.25 mg/kg on days 1 & 8 of 21-day cycle until disease progression or unacceptable toxicity. Patient weighing ≥100 kg Max: 125 mg. Recommended dose reduction for adverse events Starting dose: 1.25 mg/kg up to 125 mg. 1st dose reduction: 1 mg/kg up to 100 mg. 2nd dose reduction: 0.75 mg/kg up to 75 mg. 3rd reduction: 0.5 mg/kg up to 50 mg.

Contraindications

Hypersensitivity.

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01FX13 - enfortumab vedotin ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

Regulatory Classification

POM

Presentation/Packing

Form

Padcev powd for conc for soln for infusion 20 mg

Packing/Price

1's

Form

Padcev powd for conc for soln for infusion 30 mg

Packing/Price

1's

Padcev

enfortumab vedotin

Manufacturer:

Baxter Oncology GmbH