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.

Cutaneous T-cell lymphoma (CTCL) is a cancer of a certain type of white blood cells called T-cells. CTCL occurs when T cells grow and divide rapidly. The interleukin-2 (IL-2) receptor is a protein found on the surface of T-cells that controls the growth and division of T-cells. Some patients have a version of the IL-2 receptor that contains another protein called CD25.

CD25 testing is done to determine whether denileukin diftitox is likely to be effective in treating CTCL. If testing is not done, treatment with denileukin diftitox may not be effective.

Denileukin diftitox is approved for the treatment of patients with CTCL that has not responded to other treatment, or that has recurred. The patient's cancer cells should contain the CD25 protein in order to be treated with denileukin diftitox. Denileukin diftitox works by binding to the IL-2 receptor located on cancer cells. The drug is then taken into the cancer cells where it kills the cancer cells.

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.

Denileukin Diftitox may be found in some form under the following brand names:

• Ontak

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.

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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before taking denileukin diftitox,

• tell your doctor and pharmacist if you are allergic to denileukin diftitox or any of the ingredients in denileukin diftitox. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.

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 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.

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.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to denileukin diftitox.

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.