Denileukin Diftitox

Denileukin diftitox is a prescription medication used to treat cutaneous T-cell lymphoma (CTCL) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Denileukin diftitox belongs to a group of drugs called cytotoxic proteins. These work by killing cancer cells.

Denileukin diftitox comes as a solution (liquid) to be injected over 30 to 60 minutes intravenously (into a vein). Denileukin diftitox is administered by a doctor or nurse in a medical office or infusion center. It is usually given once a day for 5 days in a row. This cycle may be repeated every 21 days for up to eight cycles.

Common side effects include nausea, vomiting, and diarrhea.

Denileukin diftitox is used to treat cutaneous T-cell lymphoma (CTCL). in people whose disease has not improved, has gotten worse, or has come back after taking other medications. CTCL is a group of cancers of the immune system that first appear as skin rashes.

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

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose is 9 or 18 mcg/kg/day by injection over 30-60 minutes for 5 consecutive days every 21 days for 8 cycles.

WARNING: SERIOUS INFUSION REACTIONS, CAPILLARY LEAK SYNDROME AND LOSS OF VISUAL ACUITY.

The following adverse reactions have been reported:

• Serious and fatal infusion reactions. Administer Ontak in a facility equipped and staffed for cardiopulmonary resuscitation. Immediately stop and permanently discontinue Ontak for serious infusion reactions.
• Capillary leak syndrome resulting in death. Monitor weight, edema, blood pressure and serum albumin levels prior to and during Ontak treatment.
• Loss of visual acuity and color vision.

Serious side effects may occur with use of denileukin diftitox.

• You may experience a serious or life-threatening reaction while you receive a dose of denileukin diftitox injection. You will receive each dose of medication in a medical facility, and your doctor will monitor you carefully while you are receiving the medication. Your doctor will prescribe certain medications to prevent these reactions. You will take these medications by mouth shortly before you receive each dose of denileukin diftitox. If you experience any of the following symptoms during or for 24 hours after your infusion, tell your doctor immediately: fever, chills, hives, difficulty breathing or swallowing, slowed breathing, fast heartbeat, tightening of the throat, or chest pain.
• Some people who received denileukin diftitox developed life-threatening capillary leak syndrome (a condition that causes the body to keep excess fluid, low blood pressure, and low levels of a protein [albumin] in the blood). Capillary leak syndrome may occur up to 2 weeks after denileukin diftitox is given and may continue or get worse even after treatment is stopped. If you experience any of the following symptoms, call your doctor immediately: swelling of the hands, feet, ankles, or lower legs; weight gain; shortness of breath; fainting; dizziness or lightheadedness; or fast or irregular heartbeat.
• Denileukin diftitox may cause vision changes, including blurred vision, loss of vision, and loss of color vision. Vision changes may be permanent. If you experience any changes in vision call your doctor immediately.

Do not take this medication if are allergic to denileukin diftitox or to any of its ingredients.

Common side effects include the following:

• nausea
• vomiting
• diarrhea
• loss of appetite
• change in ability to taste
• feeling tired
• pain, including back, muscle, or joint pain
• cough
• headache
• weakness
• rash
• itching

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been studied. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

It is not known whether denileukin diftitox can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Animal studies have not been conducted with denileukin diftitox. This medication should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if this medication crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using this medication.

Denileukin diftitox is administered by a doctor or nurse in a medical office or infusion center. It is usually given once a day for 5 days in a row.

You may experience a serious or life-threatening reaction while you receive a dose of denileukin diftitox injection. Your doctor will prescribe certain medications to prevent these reactions.

• If you experience any of the following symptoms, call your doctor immediately: swelling of the hands, feet, ankles, or lower legs; weight gain; shortness of breath; fainting; dizziness or lightheadedness; or fast or irregular heartbeat.

Denileukin diftitox may cause vision changes, including blurred vision, loss of vision, and loss of color vision. Vision changes may be permanent. If you experience any changes in vision call your doctor immediately.