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Denileukin diftitox

Generic name: denileukin diftitox (DEN-i-loo-kin DIF-ti-toks)
Brand name: Ontak

Denileukin diftitox is used for:

Treating certain kinds of lymphoma. It may also be used for other conditions as determined by your doctor.

Denileukin diftitox is an anticancer agent called a fusion protein. It works by interfering with the growth of cancer cells, which results in the death of the cells.

Do NOT use denileukin diftitox if:

  • you are allergic to any ingredient in denileukin diftitox, including diphtheria toxin or interleukin-2

Contact your doctor or health care provider right away if any of these apply to you.

Before using denileukin diftitox:

Some medical conditions may interact with denileukin diftitox. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart disease or low blood levels of albumin

Some MEDICINES MAY INTERACT with denileukin diftitox. However, no specific interactions with denileukin diftitox are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if denileukin diftitox may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use denileukin diftitox:

Use denileukin diftitox as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Denileukin diftitox is usually administered as an infusion at your doctor's office, hospital, or clinic. Ask your doctor or pharmacist any questions that you may have about denileukin diftitox.
  • Do not shake; mix solution by gently swirling it.
  • If denileukin diftitox contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • If nausea, vomiting, diarrhea, or loss of appetite occurs, do not discontinue your medicine. Ask your doctor or pharmacist for ways to lessen these effects.
  • Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of denileukin diftitox, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use denileukin diftitox.

Important safety information:

  • Denileukin diftitox may cause dizziness or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to denileukin diftitox. Using denileukin diftitox alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Denileukin diftitox may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using denileukin diftitox.
  • LAB TESTS, including complete blood cell counts, blood chemistry, liver function, kidney function, blood pressure, and serum albumin, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use denileukin diftitox with caution in the ELDERLY because they may be more sensitive to its effects.
  • Use denileukin diftitox with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using denileukin diftitox during pregnancy. It is unknown if denileukin diftitox is excreted in breast milk. Do not breast-feed while taking denileukin diftitox.

Possible side effects of denileukin diftitox:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; confusion; constipation; cough; diarrhea; dizziness; headache; indigestion; injection site reaction; lightheadedness; loss of appetite; muscle or joint aches; nausea; nervousness; pain; runny nose; sleeplessness; sweating; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; chest pain; difficulty swallowing; fainting; fast or irregular heartbeat; flu-like symptoms (eg, fever, chills, sore throat); leg pain; severe diarrhea with nausea and vomiting; sudden unusual weight gain; swelling of the hands, legs, or ankles; vision changes (eg, loss of color vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of denileukin diftitox:

Store denileukin diftitox frozen at or below 14 degrees F (−10 degrees C). The vials may be thawed in the refrigerator at 36 to 46 degrees F (2 to 8 degrees C) for not more than 24 hours or at room temperature for 1 to 2 hours. THIS MEDICINE MUST NOT BE HEATED. Do not refreeze. Once diluted, the prepared solutions should be administered within 6 hours. Unused portions should be properly discarded immediately. Keep denileukin diftitox out of the reach of children and away from pets.

General information:

  • If you have any questions about denileukin diftitox, please talk with your doctor, pharmacist, or other health care provider.
  • Denileukin diftitox is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take denileukin diftitox or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about denileukin diftitox. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to denileukin diftitox. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using denileukin diftitox.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.