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denileukin diftitox

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

What is denileukin diftitox?

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 purposes not listed in this medication guide.

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

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).

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.

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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.

What should I discuss with my health care provider before using denileukin diftitox?

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).

To make sure denileukin diftitox is safe for you, tell your doctor if you have heart disease.

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.

FDA pregnancy category C. It is not known whether denileukin diftitox will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether denileukin diftitox passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is denileukin diftitox given?

Denileukin diftitox is injected into a vein through an IV. A healthcare provider will give you this injection.

Denileukin diftitox is usually given each day for 5 days, followed by 3 weeks off the medication.

While using denileukin diftitox, you may need frequent blood tests at your doctor's office.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your denileukin diftitox injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving denileukin diftitox?

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Denileukin diftitox side effects

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.

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.

Call your doctor at once if you have:

  • blurred vision, changes in color vision;

  • swelling in your hands, ankles, or feet;

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

  • fast heart rate;

  • back pain, trouble breathing or swallowing, chest pain or tightness, tight feeling in your throat;

  • a light-headed feeling, like you might pass out; or

  • warmth or redness in your face, neck, or chest.

Common side effects may include:

  • headache, dizziness, or nervousness;

  • numbness or tingling, skin itching or rash;

  • runny or stuffy nose;

  • 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.

See also: Side effects (in more detail)

Denileukin diftitox Dosing Information

Usual Adult Dose for Lymphoma:

9 mcg/kg/day or 18 mcg/kg/day administered IV over at least 15 minutes for five consecutive days every 21 days.

The duration of therapy has not been determined; however, only 2% of patients who did not exhibit a 25% decrease in tumor burden before the fourth course of therapy subsequently responded.

What other drugs will affect denileukin diftitox?

Other drugs may interact with denileukin diftitox, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about denileukin diftitox.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision Date: 2013-07-08, 11:09:42 AM.

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