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Brand Names: Ontak

Generic Name: denileukin diftitox (Pronunciation: de ni LOO kin DIF ti tox)

• What is denileukin diftitox (Ontak)?
• What are the possible side effects of denileukin diftitox (Ontak)?
• What is the most important information I should know about denileukin diftitox (Ontak)?
• What should I discuss with my health care provider before using denileukin diftitox (Ontak)?
• How should I use denileukin diftitox (Ontak)?
• What happens if I miss a dose (Ontak)?
• What happens if I overdose (Ontak)?
• What should I avoid while receiving denileukin diftitox (Ontak)?
• What other drugs will affect denileukin diftitox (Ontak)?
• Where can I get more information?

What is denileukin diftitox (Ontak)?

Denileukin diftitox is a designed protein containing toxins that attach themselves to certain types of malignant cells in the body. Denileukin diftitox works by destroying these malignant cells to slow the progression of cancer.

Denileukin diftitox is used to treat leukemia and lymphomas, including cutaneous (of the skin) T-cell lymphoma.

Denileukin diftitox may also be used for other purposes not listed in this medication guide.

What are the possible side effects of denileukin diftitox (Ontak)?

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• blurred vision, changes in color vision;
• swelling in your hands, ankles, or feet;
• easy bruising or bleeding, unusual weakness;
• fever, chills, body aches, cough, flu symptoms;
• fast heart rate;
• feeling light-headed, fainting;
• back pain, trouble breathing, chest pain or tightness;
• trouble swallowing, tight feeling in your throat; or
• warmth or redness in your face, neck, or chest.

Less serious side effects may include:

• headache, dizziness, or nervousness;
• numbness or tingling;
• runny or stuffy nose;
• skin itching or rash;
• weight gain or loss;
• mild diarrhea or constipation; or
• nausea, vomiting, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about denileukin diftitox (Ontak)?

You should not use denileukin diftitox if you have ever had an allergic reaction to a diphtheria vaccine or to medicines containing interleukin-2 (IL-2).

Denileukin diftitox is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection in a hospital or clinic setting. The injection normally takes about 15 minutes or longer. During this time you will be observed for side effects.

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Some patients receiving denileukin diftitox have had permanent changes in their vision or ability to see colors. Talk with your doctor about your individual risk. Tell your doctor if you have any vision changes during your treatment.