Padcev (Enfortumab Vedotin)

What it is and what it treats

Enfortumab vedotin is an antibody-drug conjugate composed of a fully human monoclonal antibody directed against Nectin-4, a cell-adhesion protein highly expressed on urothelial carcinoma cells, linked via a cleavable linker to monomethyl auristatin E (MMAE), a microtubule-disrupting cytotoxic agent. After the antibody binds Nectin-4 and the conjugate is internalised, the linker is cleaved intracellularly, releasing MMAE to arrest the cell cycle and induce apoptosis.

Padcev is authorised for adults with locally advanced or metastatic urothelial carcinoma, including use in combination with pembrolizumab in the first-line setting and as monotherapy in patients previously treated with platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor. Treatment is directed by a medical oncologist based on prior therapy, disease extent and organ function.

As a targeted conjugate, Padcev is intended to concentrate cytotoxic activity on Nectin-4-expressing tumour cells while limiting exposure of healthy tissue, though systemic toxicity, including skin, ocular, metabolic and neurological effects, still occurs and requires monitoring throughout treatment.

Presentations and dosage forms

• Powder for concentrate for solution for infusion, 20 mg and 30 mg single-use vials
• Requires reconstitution with sterile water for injection followed by dilution before intravenous administration
• Supplied for use as monotherapy or in combination with pembrolizumab according to the approved regimen

How it is administered

The approved label describes Padcev as given by intravenous infusion over approximately 30 minutes, on specific days of either a 28-day cycle (monotherapy) or a 21-day cycle (in combination with pembrolizumab), continuing until disease progression or unacceptable toxicity as assessed by the treating oncologist.

Dosing is calculated on a weight basis with a defined maximum, and dose modifications are described in the label for management of peripheral neuropathy, skin reactions, hyperglycaemia and other treatment-emergent toxicities. Any adjustment to dose or schedule is made by the prescribing physician according to observed tolerability.

Patients are monitored clinically for skin reactions from the earliest cycles, as severe cutaneous reactions have been described soon after treatment initiation, and blood glucose is monitored given reports of hyperglycaemia, particularly in patients with pre-existing diabetes or risk factors.

Storage and handling

• Store unopened vials at 2–8 °C in the original carton, protected from light
• Do not freeze and do not shake the vial
• After reconstitution and dilution, the solution has defined stability windows at refrigerated and at room temperature as described in the SmPC
• Requires validated cold-chain transport with continuous temperature monitoring
• Discard any diluted solution beyond the stated in-use period

Side effects

The following adverse reactions are described in the approved FDA prescribing information and EU product information for enfortumab vedotin.

Commonly reported

Serious effects requiring medical attention

Any new rash, blistering, mucosal involvement, unusual thirst or blurred vision should be reported promptly, as several of these reactions are the subject of a boxed warning. Suspected adverse reactions should also be reported through national pharmacovigilance schemes.

Availability and supply route

Registration of Padcev and its approved indications, including the combination with pembrolizumab, varies by country. Prescribers and procurement teams should confirm current local authorisation, approved regimen and reimbursement status with the relevant national medicines authority.

Where enfortumab vedotin is not locally registered or supply is interrupted, hospitals may pursue named-patient or unlicensed-medicine import routes, in which a licensed wholesaler sources a specific, physician-prescribed product for an individual patient in compliance with the destination country's import regulations.

Pharmacy Remedy is a licensed Turkish pharmaceutical wholesaler supplying hospitals, clinics and licensed pharmacies through verified institutional channels, operating within wholesale distribution and named-patient supply regulations. It does not sell medicines directly to members of the public.

Frequently asked questions

Primary sources

• EMA — Padcev EPAR
• FDA — Padcev prescribing information
• WHO — Model List of Essential Medicines

Further reading and regulatory routes

• How to verify a medicine is genuine
• Why medicines cost less in Türkiye
• WHO falsified medicine alerts
• Named patient supply
• UAE import guide
• For healthcare professionals
• All medicine monographs

Related medicines

• Keytruda (pembrolizumab)
• Kyprolis (carfilzomib)
• Jemperli (dostarlimab)