Denileukin diftitox (Ontak)

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Ontak was discontinued in 2014; it is unclear if this medication is still available under other branding.

General information

Class/mechanism: Recombinant diphtheria toxin fusion protein which binds with high affinity to IL-2 receptors. The fusion protein is internalized by receptor-mediated endocytosis and is cleaved, releasing the diphtheria toxin, which inhibits protein synthesis and causes cell death.[1][2][3]
Route: IV
Extravasation: no information

For conciseness and simplicity, currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 2/5/1999: Initial accelerated approval for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor.
    • 10/15/2008: Converted to regular approval.

Also known as

  • Code names: DAB(389)-interleukin-2, DAB389 interleukin-2, DAB389 interleukin-2 immunotoxin, DABIL2, LY335348
  • Brand name: Ontak