enfortumab vedotin-ejfv 20 mg intravenous solution

Generic name:
Enfortumab vedotin - injection

Pronunciation
(en-FORT-ue-mab ve-DOE-tin)

Brand name(s)
Padcev

Enfortumab vedotin may rarely cause very serious (possibly fatal) skin reactions. These skin reactions mostly happened during the first cycle of treatment but may occur later. Get medical help right away if you develop any itching, rash, blisters, peeling skin, or sores on your skin, lips, or in your mouth. Ask your doctor or pharmacist for more details.

This medication is used to treat bladder and urinary tract cancer. It works by slowing or stopping the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start using enfortumab vedotin and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by slow injection into a vein by a healthcare provider, usually over 30 minutes. Your doctor may direct you to receive this medication on certain days in a treatment cycle. Carefully follow your doctor's instructions.

The dosage is based on your medical condition, weight, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also Warning section.

Numbness/tingling in your hands/feet, muscle weakness, tiredness, nausea, vomiting, diarrhea, loss of appetite, change in how food tastes, blurred vision, or dry eyes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects.

To prevent or treat dry eyes, your doctor may direct you to use an eye lubricant, such as artificial tears. Ask your doctor or pharmacist for more information.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Leakage of medication around the injection site can happen right after you receive an injection, but sometimes may happen days after the injection. Tell your health care provider right away if you have redness, swelling, itching, or irritation at the injection site.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Get medical help right away if you have any very serious side effects, including:

• cough that doesn't go away
• chest pain
• shortness of breath

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving enfortumab vedotin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• nerve problems (such as numbness/tingling)
• liver disease

Enfortumab vedotin can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using enfortumab vedotin before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may cause blurred vision. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using enfortumab vedotin. Enfortumab vedotin may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for at least 2 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for at least 4 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for at least 3 weeks after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as blood sugar, complete blood counts, eye exams) may be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.