Enfortumab Vedotin-ejfv (en-FORT-ue-mab ve-DOE-tin - ejfv)

Treats bladder cancer.

Brand Name(s):

Padcev

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. It must be given slowly, so the needle will have to remain in place for at least 30 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how enfortumab vedotin-ejfv works. Tell your doctor if you are also using ketoconazole or rifampin.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 2 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 4 months after the last dose.
• Do not breastfeed during treatment and for at least 3 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, diabetes, eye or vision problems, or nerve problems.
• This medicine may cause the following problems:
  • Serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • Changes in blood sugar levels
  • Lung or breathing problems, including pneumonitis (swelling of the lungs), interstitial lung disease
  • Peripheral neuropathy (nerve problem)
  • Eye problems
  • Infusion site reactions
• If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blurred vision, dry eyes, eye pain, or redness
• Chest pain, cough, trouble breathing
• Fever, chills, dizziness, or skin rash while receiving the infusion
• Increased hunger or thirst, dry mouth or skin, sweating
• Muscle or bone pain
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Constipation, diarrhea, nausea
• Decreased weight or appetite
• Hair loss or thinning of the hair
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088