Padcev (Enfortumab Vedotin)

    Padcev (enfortumab vedotin) · Nectin-4-directed antibody-drug conjugate · Astellas / Pfizer

    Padcev (enfortumab vedotin) is an antibody-drug conjugate that targets Nectin-4 on urothelial cancer cells, delivering a cytotoxic microtubule inhibitor once internalised. It is approved for locally advanced or metastatic urothelial carcinoma, given by intravenous infusion, and carries warnings for skin reactions, hyperglycaemia and peripheral neuropathy.

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    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

    • Peripheral neuropathy
    • Fatigue
    • Rash
    • Decreased appetite
    • Alopecia
    • Nausea
    • Dysgeusia
    • Diarrhoea
    • Dry eye
    • Hyperglycaemia

    Serious effects requiring medical attention

    • Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (boxed warning)
    • Hyperglycaemia, including diabetic ketoacidosis
    • Pneumonitis
    • Peripheral neuropathy leading to treatment discontinuation
    • Ocular disorders
    • Infusion-site extravasation reactions

    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.

    Why the same medicine is priced differently in Türkiye

    This is how the Turkish pricing system works. These are published facts about a state mechanism, not a claim about what we charge.

    • Turkish medicine prices are calculated from a fixed pharmaceutical euro rate rather than the spot exchange rate. Under Decision No. 11031 (Resmî Gazete 33194, 12 March 2026) that rate is set at 65% of the previous year's average Turkish Central Bank euro selling rate.
    • The reference price is derived from the lowest ex-factory price in a basket of five to ten EU member states designated by the Ministry of Health.
    • A mandatory public discount of roughly 28–41% is then applied, depending on the product category and price band. The band thresholds change with each SUT revision, so we do not reproduce them here.
    • The pharmaceutical euro rate in force since 1 April 2026 is 29.1164 TL.

    Official published lists — our figures appear nowhere

    We publish no price. Each authority below publishes its own list. Read them directly:

    Compare them yourself.

    For international context: RAND Corporation, analysing 2022 data and publishing in February 2024, found US prices were 278% of prices in 33 other high-income countries, rising to 422% for brand-name originator medicines.

    How to obtain a price

    We do not publish prices. The price depends on the dose, the number of vials and the number of treatment cycles. Send your prescription and medical report and you will receive a written quote within 24 hours.

    Sourced through Türkiye pharmacy channels · İTS serial-traceable — every Turkish pack carries an İTS karekod encoding the GTIN, serial number, batch and expiry, which can be checked against Türkiye's Pharmaceutical Track and Trace System.

    How to obtain a price

    Frequently asked questions

    What is Padcev used for?

    Padcev (enfortumab vedotin) is approved for locally advanced or metastatic urothelial carcinoma, used either in combination with pembrolizumab in the first-line setting or as monotherapy after prior platinum chemotherapy and a checkpoint inhibitor.

    How does enfortumab vedotin work?

    It is an antibody-drug conjugate that binds Nectin-4 on urothelial cancer cells; once internalised, it releases the cytotoxic agent MMAE, which disrupts microtubules and induces cell death.

    How is Padcev administered?

    The label describes intravenous infusion over about 30 minutes on specified days of a 21- or 28-day cycle depending on whether it is given with pembrolizumab or as monotherapy.

    What are the main safety concerns with Padcev?

    Boxed warnings cover severe skin reactions, and the label also describes hyperglycaemia, peripheral neuropathy, pneumonitis and ocular disorders as important risks requiring monitoring.

    Does Padcev require cold-chain storage?

    Yes. Padcev vials must be stored at 2–8 °C, protected from light, and the reconstituted and diluted solution has defined stability limits described in the prescribing information.

    Is enfortumab vedotin the same as Padcev?

    Yes. Enfortumab vedotin is the international non-proprietary name of the active substance; Padcev is the brand name under which Astellas and Pfizer market it.

    Can hospitals without local registration access Padcev?

    Where enfortumab vedotin is not registered locally, hospitals may arrange named-patient or unlicensed-import supply through a licensed wholesaler, subject to a valid prescription and compliance with local import regulations.

    Primary sources

    Further reading and regulatory routes

    Related medicines

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    Reviewed by Pharmacy Remedy Pharmacovigilance & Compliance Desk · Last updated: 2026-07-30

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