enfortumab vedotin

What is the most important information I should know about enfortumab vedotin?

What is enfortumab vedotin?

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.

What should I discuss with my healthcare provider before receiving enfortumab vedotin?

Tell your doctor if you have ever had:

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

• 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.

How is enfortumab vedotin given?

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.

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?

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving enfortumab vedotin?

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

What are the possible side effects of enfortumab vedotin?

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

• 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.

What other drugs will affect enfortumab vedotin?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about enfortumab vedotin.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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