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Denileukin Diftitox

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Information about Denileukin Diftitox

Denileukin diftitox is a recombinant fusion protein of human interleukin-2 (IL-2) attached to diphtheria toxin fragments A and B that is used as an antineoplastic agent to treat cutaneous T cell lymphomas that express IL-2 receptors.   

Liver safety of Denileukin Diftitox

High doses of denileukin diftitox can cause mild-to-moderate elevations in serum enzymes and bilirubin, but rarely result in clinically significant acute liver injury

Mechanism of action of Denileukin Diftitox

Denileukin (den" i loo' kin) diftitox (dif' ti tox) is a fusion protein that combines human interleukin-2 (IL-2) with diphtheria toxin fragments A and B. 

FDA approval information for Denileukin Diftitox

Denileukin diftitox was approved for use in the United States in 1999 and the indications remain limited to therapy of refractory cutaneous T cell lymphomas that express the CD25 component of the IL-2 receptor on the surface of the malignant cells.  Once taken up by the cells expressing the IL-2 receptor, the diphtheria toxin is released into the cytoplasm causing cell death. 

Dosage and administration for Denileukin Diftitox

Denileukin diftitox is available in solution in 2 mL single use vials of 150 µg/mL under the brand name Ontak.  The typical dose is 9 to 18 µg/kg given intravenously once daily for 5 consecutive days every 21 days for up to 8 cycles. 

Side effects of Denileukin Diftitox

side effects are common with denileukin diftitox therapy, and it should be administered in a hospital setting under the supervision of physicians experienced in the use of anticancer agents. Common side effects include fatigue, fever, chills, nausea, diarrhea, arthralgia, headache and rash.  Up to 25% of patients develop capillary leak syndrome leading to peripheral edema, hypotension and renal insufficiency and can cause shock, pulmonary edema, renal failure and death.  Less common but potentially severe adverse reactions include anaphylaxis, severe infections, thrombotic events and pancreatitis.


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