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Overview
Padcev is approved by the U.S. Food and Drug Administration (FDA) to treat several forms of bladder cancer. It is approved in combination with pembrolizumab (Keytruda) or with pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) as a perioperative (before and after surgery) treatment for adults with muscle-invasive bladder cancer (MIBC) who are not eligible for cisplatin-based chemotherapy. It is also approved to treat locally advanced or metastatic urothelial cancer (mUC), either in combination with pembrolizumab or as a single agent in people who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-based chemotherapy, or those who cannot receive cisplatin and have received at least one prior treatment. Padcev is also known by its drug name, enfortumab vedotin.

Padcev is a nectin-4-directed antibody-drug conjugate. It works by attaching to a protein called nectin-4 on the surface of cancer cells and delivering a chemotherapy agent directly into the cells. This targeted delivery disrupts the cancer cell's internal structure, leading to its death.

How do I take it?
Prescribing information states that Padcev is given as an intravenous (IV) infusion. In perioperative use for MIBC, it is combined with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph and given before surgery (neoadjuvant) on Days 1 and 8 of a 21-day cycle for three cycles, then after surgery (adjuvant) on the same schedule for up to six cycles. In other cases, when used for advanced or metastatic disease, it may be given alone or with pembrolizumab on a similar schedule. Infusions typically last about 30 minutes. Padcev should be administered exactly as prescribed by a healthcare provider.

Side Effects

Common side effects of Padcev when used alone include increased blood sugar, liver enzyme elevations (aspartate and alanine aminotransferase), low white and red blood cells, increased creatinine (kidney function marker), rash, fatigue, peripheral neuropathy (nerve damage), hair loss, nausea, diarrhea, dry eyes, constipation, changes in taste, weight loss, and dry skin.

When used with pembrolizumab in MIBC or metastatic disease, additional common side effects may include urinary tract infection, itching, low sodium, low phosphate, low potassium, dry eye, and decreased appetite.

Rare but serious side effects may include severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, high blood sugar that can lead to diabetic ketoacidosis, severe lung inflammation (pneumonitis or interstitial lung disease), peripheral neuropathy (nerve damage) that may worsen over time, vision changes and other eye disorders, infusion site damage from leakage of the drug, and embryo-fetal toxicity (harm to an unborn fetus) when taken during pregnancy. 

For more information about this treatment, visit:

Padcev (Enfortumab Vedotin-Ejfv) for Injection, for Intravenous Use — Astellas

Pharma US

 

 

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