Denileukin diftitox (DAB389 IL-2, Ontak) is indicated for treatment of patients with cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor. Denileukin diftitox is a recombinant fusion protein composed of IL-2 amino acid sequences joined to sequences of diphtheria toxin. The drug targets and destroys cells expressing the high-affinity (CD25/CD122/CD132) IL-2 receptor, including the malignant cells of cutaneous T-cell lymphoma.
The half-life of the drug is approximately 75 minutes after intravenous infusion. Antibodies directed against the diphtheria domain decrease mean systemic exposure by approximately 75%. Approximately 85% of patients develop such antibodies after a single course of treatment, and nearly all do after 3 cycles.
Most patients using denileukin diftitox have flulike symptoms (fever, chills, myalgias, nausea, diarrhea) within a few hours to days of treatment. Another common adverse effect is an immediate hypersensitivity syndrome in which hypotension, back pain, dyspnea, chest pain or tightness, and rash may occur. Other notable side effects include a vascular leak syndrome (edema, hypoalbuminemia, hypotension), infections, and elevations of transaminases.
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