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Enfortumab vedotin

Generic Name: enfortumab vedotin (en FORT ue mab ve DOE tin)
Brand Name: Padcev
Dosage Forms: intravenous powder for injection (20 mg; 30 mg)

Medically reviewed by on March 13, 2020. Written by Cerner Multum.

What is enfortumab vedotin?

Enfortumab vedotin is used to treat cancer of the bladder or urinary tract in adults.

enfortumab vedotin is used when the cancer is advanced, 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 or platinum cancer medicine.

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


Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Tell your doctor if you have ever had:

  • numbness or tingling in your hands or feet;

  • diabetes; or

  • high blood sugar.

Enfortumab vedotin can harm an unborn baby or cause birth defects if the mother or the father is using enfortumab vedotin.

  • If you are a woman, do not use enfortumab vedotin if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose.

  • If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.

  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using enfortumab vedotin.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because enfortumab vedotin can harm an unborn baby.

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

How is enfortumab vedotin given?

Enfortumab vedotin is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when enfortumab vedotin is injected.

Enfortumab vedotin is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with this medicine.

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.

What happens if I miss a dose?

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

What happens if I overdose?

Since enfortumab vedotin is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving enfortumab vedotin?

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

Enfortumab vedotin side effects

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

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

  • increased thirst, dry mouth, fruity breath odor;

  • increased urination,

  • confusion, drowsiness; or

  • nausea, vomiting, stomach pain, loss of appetite.

Also call your doctor at once if you have:

  • numbness, tingling, or burning pain in your hands or feet;

  • pain, redness, and peeling skin on your hands or feet;

  • a severe skin rash with itching, scaling, or blisters;

  • severely dry eyes, vision problems; or

  • redness, itching, swelling, or discomfort where the medicine was injected.

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

Common side effects may include:

  • numbness or tingling;

  • muscle weakness;

  • feeling tired;

  • nausea, loss of appetite, diarrhea;

  • rash, dry skin;

  • hair loss; or

  • changes in your sense of taste.

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.

Enfortumab vedotin dosing information

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

What other drugs will affect enfortumab vedotin?

Some 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.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.