Denileukin diftitox (Ontak)
Ontak was discontinued in 2014; it is unclear if this medication is still available in the US under other branding; it is available in Japan as Remitoro.
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, HemOnc.org 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
- Denileukin diftitox (Ontak) patient drug information (Chemocare)[4]
- Brief patient counseling information can be found on page 5 of the Denileukin diftitox (Ontak) package insert[1]
- Denileukin diftitox (Ontak) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 1999-02-05: 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. (Based on L4389-10)
- 2008-10-15: Converted to regular 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. (Based on L4389-11)
History of changes in PMDA indication
- 2021-03-23: Newly indicated for the treatment of relapsed or refractory peripheral T-cell lymphoma and relapsed or refractory cutaneous T-cell lymphoma.
Also known as
- Code names: DAB(389)-interleukin-2, DAB389 interleukin-2, DAB389 interleukin-2 immunotoxin, DAB-IL2, LY-335348
- Brand name: Ontak, Remitoro