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Precautions and Warnings With Denileukin Diftitox

Vision problems, infusion reactions, and other potentially serious problems may occur in some people who receive denileukin diftitox. Safety warnings and precautions should be fully reviewed before using this drug, particularly in people who have a history of low albumin levels and those with certain allergies. Reviewing this information can help prevent potentially life-threatening complications.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to receiving denileukin diftitox (Ontak®) if you have:
  • Been told you have low levels of albumin (a protein found in the body)
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Denileukin Diftitox Precautions and Warnings

Some warnings and precautions to be aware of prior to receiving this medication include the following:
  • The majority of people in clinical studies on denileukin diftitox experienced infusion reactions, which are potentially life-threatening reactions that can occur during or within 24 hours of receiving the medication. Tell your healthcare provider immediately if you have symptoms of an allergic reaction, which may include but are not limited to:
    • Fever
    • Chills
    • Difficulty breathing or swallowing
    • Chest pain
    • Fast heartbeat
    • Hives.
  • There have been reports of a rare but serious condition known as capillary leak syndrome with denileukin diftitox use. This condition occurs when fluid from blood vessels leaks out into nearby body cavities and muscles, causing low blood pressure and potential damage to vital organs. Contact your healthcare provider right away if you experience signs of this condition, which may include:
    • Low blood pressure, which could cause dizziness or fainting
    • Swelling of the hands, legs, ankles, or feet
    • Unexplained weight gain.
  • Denileukin diftitox may cause vision changes, which could be permanent. Let your healthcare provider know right away if you have any changes in vision during treatment, including a decrease in vision or a loss of color vision.
  • This medicine is only approved to treat cutaneous T-cell lymphoma that expresses a protein known as CD25. Your healthcare provider can test your tumor cells for this protein by taking a biopsy.
  • Your healthcare provider will monitor your blood levels of albumin (a protein found in the body) before each five-day treatment course and postpone your treatment if your albumin level is too low. A low albumin level can be a sign of a potentially dangerous condition known as capillary leak syndrome.
  • Denileukin diftitox is a pregnancy Category C medication, which means it may not be safe for use during pregnancy (see Ontak and Pregnancy).
  • It is unknown whether denileukin diftitox passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Ontak and Breastfeeding).
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Denileukin Diftitox Drug Information

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