Difference between revisions of "Denileukin diftitox (Ontak)"
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==History of changes in FDA indication== | ==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 | cutaneous T-cell lymphoma]] whose malignant cells [[Biomarkers#Expression|express]] the [[Biomarkers#CD25|CD25]] component of the IL-2 receptor. ''(Based on L4389-10)'' | * 2/5/1999: Initial accelerated approval for the treatment of patients with persistent or recurrent [[Cutaneous T-cell lymphoma | cutaneous T-cell lymphoma]] whose malignant cells [[Biomarkers#Expression|express]] the [[Biomarkers#CD25|CD25]] component of the IL-2 receptor. ''(Based on L4389-10)'' | ||
− | + | * 10/15/2008: Converted to regular approval for the treatment of patients with persistent or recurrent [[Cutaneous T-cell lymphoma | cutaneous T-cell lymphoma]] whose malignant cells [[Biomarkers#Expression|express]] the [[Biomarkers#CD25|CD25]] component of the IL-2 receptor. ''(Based on L4389-11)'' | |
==Also known as== | ==Also known as== |
Revision as of 11:13, 19 June 2022
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, 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
- 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. (Based on L4389-10)
- 10/15/2008: 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)
Also known as
- Code names: DAB(389)-interleukin-2, DAB389 interleukin-2, DAB389 interleukin-2 immunotoxin, DABIL2, LY335348
- Brand name: Ontak