Enfortumab vedotin-ejfv Injection

IMPORTANT WARNING:

Enfortumab vedotin-ejfv may cause serious or life-threatening skin reactions. Your doctor will monitor you closely for skin reactions while you are receiving the medication. If you experience any of the following symptoms, call your doctor immediately: new or worsening rash or itching, blisters or peeling skin, or painful sores or ulcers on your skin, lips, nose, or in your mouth; fever or flu-like symptoms; or swollen glands.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to enfortumab vedotin-ejfv.

Talk to your doctor about the risks of receiving enfortumab vedotin-ejfv injection.

WHY is this medicine prescribed?

Enfortumab vedotin-ejfv injection is used alone or in combination with pembrolizumab (Keytruda) to treat urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that has spread to nearby tissues or other parts of the body or cannot be removed by surgery, and has worsened after treatment with other chemotherapy medications or if these chemotherapy medications cannot be used for treatment. Enfortumab vedotin-ejfv injection is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Enfortumab vedotin-ejfv injection comes as a powder to be mixed with liquid and injected intravenously (into a vein) over 30 minutes by a doctor or nurse in a hospital or medical facility. When enfortumab vedotin-ejfv injection is given alone, it is usually injected on days 1, 8, and 15 of a 28-day cycle for as long as your doctor recommends that you receive treatment. When enfortumab vedotin-ejfv injection is given in combination with pembrolizumab, it is usually given on days 1 and 8 of a 21-day cycle for as long as your doctor recommends that you receive treatment.

Your doctor may delay or stop your treatment with enfortumab vedotin-ejfv injection, or treat you with additional medications, depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving enfortumab vedotin-ejfv injection,

• tell your doctor and pharmacist if you are allergic to enfortumab vedotin-ejfv injection, any other medications, or any of the ingredients in enfortumab vedotin-ejfv injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had peripheral neuropathy (a type of nerve damage that causes tingling, numbness, and pain in the hands and feet); diabetes or high blood sugar; abnormal blood levels of sodium, phosphate, potassium, or calcium; lung or pancreas problems,;or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving enfortumab vedotin-ejfv injection. Your doctor may perform a pregnancy test to be sure that you are not pregnant before you receive enfortumab vedotin-ejfv injection. If you are female, you should use birth control during your treatment and for 2 months after your final dose. If you are male, you and your female partner should use birth control during your treatment and for 4 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while receiving enfortumab vedotin-ejfv injection, call your doctor. Enfortumab vedotin-ejfv injection may harm the fetus.

• tell your doctor if you are breast-feeding. You should not breast-feed while you are receiving enfortumab vedotin-ejfv injection and for at least 3 weeks after your final dose.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of receiving enfortumab vedotin-ejfv injection.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are receiving this medication, even if you do not already have diabetes. Tell your doctor immediately if you have any of the following symptoms while you are receiving enfortumab vedotin-ejfv injection: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

• you should know that this medication may cause dry eyes and other eye problems, which may be serious. Your doctor may tell you to use artificial tears or lubricant eye drops during your treatment with enfortumab vedotin-ejfv.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Enfortumab vedotin-ejfv injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• vomiting
• nausea
• constipation
• loss of appetite
• weight loss
• taste changes
• hair loss
• dry skin
• unusual tiredness or lack of energy
• dizziness
• muscle, joint, back, or bone pain
• swelling of the arms, hands, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of these symptoms or those in the SPECIAL PRECAUTIONS or IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• shortness of breath
• trouble breathing
• cough
• pale skin
• unusual bleeding or bruising
• skin redness, swelling, fever, or pain at injection site
• blurred vision, loss of vision, eye pain or redness, watery eyes, or other visual changes
• numbness, burning, or tingling in hands or feet
• muscle weakness
• difficult or painful urination
• cloudy, discolored, or bloody urine

Enfortumab vedotin-ejfv injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about enfortumab vedotin-ejfv injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.