Enfortumab Vedotin Injection

What is this medication?

ENFORTUMAB VEDOTIN (en FORT ue mab ve DOE tin) treats bladder cancer and kidney cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): PADCEV

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Eye disease
• Liver disease
• Lung disease
• Tingling of the fingers or toes or other nerve disorder
• Vision problems
• An unusual or allergic reaction to enfortumab vedotin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

This medication may affect how other medications work, and other medications may affect how this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

This medication can cause a serious condition in which there is too much acid in your blood. If you develop nausea, vomiting, stomach pain, unusual tiredness, or trouble breathing, stop taking this medication and call your care team right away. If possible, use a ketone dipstick to check for ketones in your urine.

This medication may cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe.

Tell your care team right away if you have any change in your eyesight.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 2 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 2 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medicine or for at least 3 weeks after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Painful swelling, warmth, or redness of the skin, blisters or sores at the infusion site
• Pain, tingling, or numbness in the hands or feet
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in taste
• Diarrhea
• Dry eyes
• Fatigue
• Hair loss
• Loss of appetite

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.