Enfortumab vedotin injection

What is this medication?

ENFORTUMAB VEDOTIN (en FORT ue mab ve DOE tin) is a chemotherapy medicine and monoclonal antibody. It treats urothelial cancer.

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 (high blood sugar)
• eye disease, vision problems
• lung disease
• skin conditions or sensitivity
• tingling of the fingers or toes, or other nerve disorder
• an unusual or allergic reaction to enfortumab vedotin, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is injected into a vein. It is given by a health care provider in a hospital or clinic setting.

Talk to your health care provider about the use of this medicine 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 doctor or health care provider if you are unable to keep an appointment.

What may interact with this medication?

This medicine may also interact with the following medications:

• certain antivirals for HIV
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• clarithromycin
• grapefruit juice
• mifepristone
• telithromycin

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?

This medicine 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 health care provider tells you to stop.

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

Do not become pregnant while taking this medicine or for 2 months after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 4 months after stopping it. There is potential for serious side effects to an unborn child. Talk to your health care provider for more information.

Do not breast-feed an infant while taking this medicine or for at least 3 weeks after stopping it.

This medicine may make it more difficult to father a child. Talk to your health care provider if you are concerned about your fertility.

This medicine may increase blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

This medicine 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 breathing problems, stop taking this medicine and call your health care provider right away. If possible, use a ketone dipstick to check for ketones in your urine.

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

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

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

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider 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. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• blurred vision
• changes in vision
• cough
• dry eyes
• high blood sugar (increased hunger, thirst or urination; unusually weak or tired, blurry vision)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• pain, tingling, numbness in the hands or feet
• redness, blistering, peeling, bleeding, swelling, or loosening of the skin on the palms of your hands or soles of your feet or inside the mouth
• trouble breathing

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

• changes in taste
• diarrhea
• dry skin
• hair loss
• loss of appetite
• nausea, vomiting
• weak or tired

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 medicine is given in a hospital or clinic and 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.