Padcev

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

This monograph is about the following enfortumab vedotin product: enfortumab vedotin-ejfv.

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

This medication is given by injection into a vein by a health care provider as directed by your doctor, usually over 30 minutes. The injection is usually given on days 1, 8, and 15 of every treatment cycle. Each treatment cycle is 28 days.

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

Use this medication regularly to get the most benefit from it. It may help to mark your calendar when to receive each dose.

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/skin 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, your doctor has prescribed this drug because he or she 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 increase the risk of high blood sugar (hyperglycemia). Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away.

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).

Enfortumab vedotin can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

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).

Enfortumab vedotin can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. 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).

This medication can affect fertility in males. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication. You should not become pregnant while using enfortumab vedotin. Enfortumab vedotin may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 2 months after the last dose. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for 4 months after the last dose. If you become 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, breast-feeding while using this drug and for at least 3 weeks after the last dose is not recommended. Consult your doctor before breast-feeding.

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

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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.

Do not share this medication with others.

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.