Denileukin Diftitox

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names


Greece: Ontak.

North America

USA: Ontak.

Drug combinations


Denileukin Diftitox: C~2560~H~4036~N~678~O~799~S~17~. Mw: 57647,3. N-L-Methionyl-387-L-histidine-388-L-alanine-1-388-toxin (Corynebacterium diphtheriae strain C7)(388→2′) protein with 2-133-interleukin 2 (human clone pTIL2-21a). CAS-173146-27-5 (1997).

Pharmacologic Category

Other Antineoplastic Agents. (ATC-Code: L01XX29).

Mechanism of action

Fusion protein (a combination of amino acid sequences from diphtheria toxin and IL-2) which selectively delivers the cytotoxic activity of diphtheria toxin to targeted cells. It interacts with the high-affinity IL-2 receptor on the surface of malignant cells to inhibit intracellular protein synthesis, rapidly leading to cell death.

Therapeutic use

Treatment of persistent or recurrent cutaneous T-cell lymphoma in patients whose malignant cells express the CD25 component of the IL-2 receptor. Designated an orphan drug by the FDA for use in this condition.

Pregnancy and lactiation implications

Animal reproduction studies not conducted. Should be given to a pregnant woman only if clearly needed. Lactation is contraindicated during therapy (potential risk).

Unlabeled use


Hypersensitivity to denileukin diftitox, diphtheria toxin, IL-2, or any component of the formulation.

Warnings and precautions

Acute hypersensitivity reactions and a flu-like syndrome developed during infusion. May develop immunogenicity. May impair immune function (patients with cutaneous T-cell lymphoma are predisposed to cutaneous infection). Associated with delayed-onset vascular leak syndrome (should be used with caution in preexisting cardiovascular disease and/or low serum albumin concentrations). Visual disturbances may occur. Caution in patients >65 years (higher incidence and greater severity of anorexia, hypotension, anemia, confusion, rash, nausea, and/or vomiting observed).



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