Difference between revisions of "Romidepsin (Istodax)"
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==General information== | ==General information== | ||
| − | Class/mechanism: <ref name="insert">[http://www.istodax.com/pdfs/ISTODAX_PackageInsert.pdf Romidepsin ( | + | Class/mechanism: Histone deacetylase (HDAC) inhibitor. HDACs normally catalyze removal of acetyl groups from acetylated lysine residues in histones and non-histone proteins, which helps to regulate gene expression. Inhibition of histone deacetylases results in hyperacetylation of histones and modulates gene expression by creating an open chromatin state that leads to expression of previously silenced genes. Although the mechanism of action is not fully understood, inhibiting HDACs has been observed to result in cell cycle arrest and apoptosis of cancer cells.<ref name="insert">[http://www.istodax.com/pdfs/ISTODAX_PackageInsert.pdf Romidepsin (Istodax) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/romidepsin.pdf Romidepsin (Istodax) package insert (locally hosted backup)]</ref> |
| − | <br>Route: | + | <br>Route: IV |
| − | <br>Extravasation: | + | <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 such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *[[Cutaneous T-cell lymphoma]] | ||
| + | *[[Peripheral T-cell lymphoma]] ''Note: this indication remains in Japan but was withdrawn from the USA.'' | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[http://www.uptodate.com/contents/romidepsin-patient-drug-information Romidepsin ( | + | *[http://www.istodax.com/pdfs/ISTODAX_PackageInsert.pdf#page=8 Romidepsin (Istodax) package insert PDF pages 8-9]<ref name="insert"></ref> |
| + | *[http://www.uptodate.com/contents/romidepsin-patient-drug-information Romidepsin (Istodax) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/romidepsin-patient-drug-information Romidepsin (Istodax) patient drug information (UpToDate)]</ref> | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | ===[[Cutaneous T-cell lymphoma]]=== | ||
| + | * 2009-11-05: Initial FDA approval for treatment of [[Cutaneous T-cell lymphoma | cutaneous T-cell lymphoma (CTCL)]] in patients who have received at least one prior systemic therapy. ''(Based on NIH 01-C-0049<sub>CTCL</sub> and GPI-04-0001)'' | ||
| + | |||
| + | ===[[Peripheral T-cell lymphoma]] - '''WITHDRAWN'''=== | ||
| + | * 2011-06-16: Additional indication for treatment of [[Peripheral T-cell lymphoma | peripheral T-cell lymphoma (PTCL)]] in patients who have received at least one prior therapy. ''(Based on GPI-06-0002)'' | ||
| + | **2021-07-30: Approval for treatment of [[Peripheral T-cell lymphoma | peripheral T-cell lymphoma (PTCL)]] in patients who have received at least one prior therapy withdrawn. ''(Based on LYSA Ro-CHOP)'' | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2013-10-16: Initial notice of compliance with conditions for the treatment of patients with relapsed/refractory [[Peripheral T-cell lymphoma |peripheral T-cell lymphoma (PTCL)]] who are not eligible for transplant and have received at least one prior systemic therapy. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2017-07-03: New approval for the treatment of relapsed or refractory [[peripheral T-cell lymphoma]]. | ||
| + | ==Also known as== | ||
| + | *'''Code names:''' FK-228, FR-901228, NSC-630176 | ||
| + | *'''Generic name:''' depsipeptide | ||
| + | *'''Brand name:''' Istodax | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| + | |||
| + | [[Category:Drugs]] | ||
| + | [[Category:Intravenous medications]] | ||
| + | |||
| + | [[Category:HDAC inhibitors]] | ||
| + | |||
| + | [[Category:Cutaneous T-cell lymphoma medications]] | ||
| + | [[Category:Peripheral T-cell lymphoma medications]] | ||
| + | |||
| + | [[Category:FDA approved in 2009]] | ||
| + | [[Category:Health Canada approved in 2013]] | ||
| + | [[Category:PMDA approved in 2017]] | ||
Latest revision as of 19:30, 23 June 2024
General information
Class/mechanism: Histone deacetylase (HDAC) inhibitor. HDACs normally catalyze removal of acetyl groups from acetylated lysine residues in histones and non-histone proteins, which helps to regulate gene expression. Inhibition of histone deacetylases results in hyperacetylation of histones and modulates gene expression by creating an open chromatin state that leads to expression of previously silenced genes. Although the mechanism of action is not fully understood, inhibiting HDACs has been observed to result in cell cycle arrest and apoptosis of cancer cells.[1][2]
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
- Cutaneous T-cell lymphoma
- Peripheral T-cell lymphoma Note: this indication remains in Japan but was withdrawn from the USA.
Patient drug information
- Romidepsin (Istodax) package insert PDF pages 8-9[1]
- Romidepsin (Istodax) patient drug information (UpToDate)[3]
History of changes in FDA indication
Cutaneous T-cell lymphoma
- 2009-11-05: Initial FDA approval for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. (Based on NIH 01-C-0049CTCL and GPI-04-0001)
Peripheral T-cell lymphoma - WITHDRAWN
- 2011-06-16: Additional indication for treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. (Based on GPI-06-0002)
- 2021-07-30: Approval for treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy withdrawn. (Based on LYSA Ro-CHOP)
History of changes in Health Canada indication
- 2013-10-16: Initial notice of compliance with conditions for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy.
History of changes in PMDA indication
- 2017-07-03: New approval for the treatment of relapsed or refractory peripheral T-cell lymphoma.
Also known as
- Code names: FK-228, FR-901228, NSC-630176
- Generic name: depsipeptide
- Brand name: Istodax