Difference between revisions of "Denileukin diftitox (Ontak)"
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| + | '''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== | ==General information== | ||
| − | Class/mechanism: Recombinant diphtheria toxin fusion protein which binds with high affinity to IL-2 receptors. | + | 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.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103767s5094lbl.pdf Denileukin diftitox (Ontak) package insert]</ref><ref>[[:File:Denileukindiftitox.pdf | Denileukin diftitox (Ontak) package insert (locally hosted backup)]]</ref><ref>[http://us.eisai.com/section.asp?ID=257 Ontak manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>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. | + | 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 or the prescribing information.<ref name="insert"></ref> |
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *[[Cutaneous T-cell lymphoma]] | ||
| + | *[[Peripheral T-cell lymphoma]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[https://chemocare.com/druginfo/denileukin-diftitox.aspx Denileukin diftitox (Ontak) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/denileukin-diftitox.aspx Denileukin diftitox (Ontak) patient drug information (Chemocare)]</ref> |
| + | *Brief patient counseling information can be found on [https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103767s5094lbl.pdf#page=5 page 5 of the Denileukin diftitox (Ontak) package insert]<ref name="insert"></ref> | ||
*[http://www.uptodate.com/contents/denileukin-diftitox-patient-drug-information Denileukin diftitox (Ontak) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/denileukin-diftitox-patient-drug-information Denileukin diftitox (Ontak) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/denileukin-diftitox-patient-drug-information Denileukin diftitox (Ontak) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/denileukin-diftitox-patient-drug-information Denileukin diftitox (Ontak) patient drug information (UpToDate)]</ref> | ||
| + | |||
| + | ==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 [[Biomarkers#Expression|express]] the [[Biomarkers#CD25|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 [[Biomarkers#Expression|express]] the [[Biomarkers#CD25|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 | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| + | |||
| + | [[Category:Drugs]] | ||
| + | [[Category:Intravenous medications]] | ||
| + | [[Category:Protein expression-specific medications]] | ||
| + | |||
| + | [[Category:Anti-IL-2R immunotoxins]] | ||
| + | |||
| + | [[Category:Cutaneous T-cell lymphoma medications]] | ||
| + | [[Category:Peripheral T-cell lymphoma medications]] | ||
| + | |||
| + | [[Category:FDA approved in 1999]] | ||
| + | [[Category:Discontinued drugs]] | ||
Latest revision as of 01:03, 29 June 2024
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 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