Enfortumab vedotin is used to treat cancer of the bladder or urinary tract that has spread to other parts of the body (metastatic), or cannot be removed with surgery.

Enfortumab vedotin is usually given after other treatments such as immunotherapy and platinum cancer medicine, or if you are unable to receive platinum cancer medicine.

Enfortumab vedotin may also be used for purposes not listed in this medication guide.

Tell your doctor if you have ever had:

• numbness or tingling in your hands or feet;
• diabetes;
• high blood sugar;
• liver disease.

Enfortumab vedotin can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 2 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 3 weeks after your last dose.

Use Enfortumab Vedotin (Padcev) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medicine can cause a severe or life-threatening skin rash. Get emergency medical help if you have a worsening rash with itching, blistering, peeling, skin lesions that look like rings, a fever or flu-like symptoms, swollen glands, or painful sores in your mouth, nose, throat, or genital area.

Call your doctor at once if you have symptoms of high blood sugar:

• increased thirst, dry mouth, fruity breath odor;
• increased urination;
• blurred vision, confusion, drowsiness; or
• nausea, vomiting, stomach pain, loss of appetite.

Also call your doctor at once if you have:

• numbness, tingling, or muscle weakness in your hands or feet;
• new or worsening cough, trouble breathing, or shortness of breath;
• pain, redness, and peeling skin on your hands or feet;
• severely dry eyes, vision problems;
• redness, itching, swelling, or discomfort where the medicine was injected; or
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• high blood sugar;
• numbness or tingling;
• muscle weakness;
• low blood cell counts;
• feeling tired;
• nausea, diarrhea;
• loss of appetite, weight loss;
• rash, dry skin, itching;
• changes in your sense of taste;
• hair loss; or
• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.