Denileukin Diftitox-cxdl (den-i-LOO-kin DIF-ti-tox - cxdl)

Treats skin cancer.

Brand Name(s):

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. This must be given slowly, so the IV will have to remain in place for at least 60 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.
• Your doctor may also give you extra fluids and other medicines (including allergy medicine, fever medicine, steroid, or medicine to prevent nausea or vomiting) 30 minutes before receiving this medicine.

Drugs and Foods to Avoid:

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

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 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 to keep from getting pregnant during treatment and for 7 days after the last dose.
• Do not breastfeed during treatment and for 7 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, low blood pressure, or edema (swelling).
• This medicine may cause the following problems:
  • Capillary leak syndrome
  • Vision changes
  • Infusion-related reactions
  • Liver problems
• Some men who receive this medicine have become infertile (unable to have children). Talk with your doctor before starting treatment with this medicine if you plan 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
• Bloody or cloudy urine, change in how much or how often you urinate, painful or difficult urination
• Blurred vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills
• Headache, dizziness, mental changes
• Rapid weight gain, swelling in your hands, ankles, or feet

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

• Constipation, diarrhea
• Muscle or joint pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Tiredness, trouble sleeping

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