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.

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.

Enfortumab vedotin is injected into a vein by a healthcare provider.

This medicine must be given slowly over 30 minutes.

Tell your medical caregivers if you feel any burning or pain when enfortumab vedotin is injected.

Enfortumab vedotin is given in a 28-day treatment cycle. You will receive an injection only on certain days of this cycle. Your doctor will determine how many cycles you need.

This medicine can cause a severe or life-threatening skin rash, especially during the first treatment cycle. Call your doctor right away if you have a new skin rash with itching that gets worse.

Enfortumab vedotin can cause high blood sugar (hyperglycemia) even if you have never had it before or if you are not diabetic. Severe hyperglycemia may be life-threatening. Your blood sugar may need to be checked often.

Enfortumab vedotin can also cause dry eyes. Your doctor may tell you to use artificial-tear eye drops to help prevent dry eyes.

Usual Adult Dose for Urothelial Carcinoma:

1.25 mg/kg (up to a maximum of 125 mg for patients 100 kg or greater) IV over 30 minutes on Days 1, 8. and 15 of a 28-day cycle until disease progression or unacceptable toxicity

Use: For locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting

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 enfortumab vedotin.

• 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.

Call your doctor for instructions if you miss an appointment for your enfortumab vedotin injection.

In a medical setting an overdose would be treated quickly.

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

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

enfortumab vedotin 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 of enfortumab vedotin 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.

Many drugs can affect your blood levels of enfortumab vedotin, which may increase side effects. Tell your doctor about all your other medicines, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.