Padcev (Enfortumab Vedotin) for bladder cancer

Overview
Padcev is approved by the U.S. Food and Drug Administration (FDA) for treating adults with locally advanced or metastatic urothelial cancer, the most common type of bladder cancer. It is prescribed either in combination with pembrolizumab for individuals who have not received prior systemic therapy or as a single agent for those who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy. Additionally, it is used for those who cannot receive cisplatin-containing chemotherapy and have received one or more prior treatments. Padcev is also known by its drug name, enfortumab vedotin.

Padcev is a nectin-4-directed antibody-drug conjugate. It works by binding to nectin-4, a protein often found on cancer cells, and delivering a cytotoxic agent that disrupts the cancer cells’ internal structure, leading to cell death.

How do I take it?
Prescribing information states that Padcev is administered as an intravenous (IV) infusion. When used in combination with pembrolizumab, it is given on days 1 and 8 of a 21-day cycle. As a single agent, it is administered on days 1, 8, and 15 of a 28-day cycle. The infusion typically lasts 30 minutes. Padcev should be administered exactly as prescribed by a health care provider.

Side Effects
Common side effects of Padcev as a single agent, according to prescribing information, include increased glucose (blood sugar), increased aspartate aminotransferase (a liver enzyme), decreased lymphocytes (a type of white blood cell), increased creatinine (indicating kidney changes), rash, fatigue, peripheral neuropathy (nerve damage), decreased albumin (a blood protein), decreased hemoglobin (red blood cells), hair loss, decreased appetite, decreased neutrophils (a type of white blood cell), decreased sodium, increased alanine aminotransferase (another liver enzyme), decreased phosphate, diarrhea, nausea, itching, increased urate (uric acid levels), dry eye, altered taste perception, constipation, increased lipase (an enzyme related to fat digestion), decreased weight, decreased platelets (blood cells important for clotting), abdominal pain, and dry skin.

When taken with pembrolizumab, additional side effects may include urinary tract infection, decreased potassium, increased potassium, and dysgeusia (altered taste perception).

Rare but serious side effects may include hyperglycemia (high blood sugar), severe or fatal lung inflammation (pneumonitis or interstitial lung disease), peripheral neuropathy, ocular  (eye-related) disorders, including vision changes and dry eyes, infusion site extravasation (leakage of medication into surrounding tissue), and embryo-fetal toxicity (harm to an unborn fetus) when taken during pregnancy. 

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Label: Padcev EJFV — Enfortumab Vedotin Injection, Powder, Lyophilized, for Solution — DailyMed