Difference between revisions of "Vorinostat (Zolinza)"

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==General information==
 
==General information==
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Class/mechanism: <ref name="insert">[http://www.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_pi.pdf Vorinostat (Zolinza) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/vorinostat.pdf Vorinostat (Zolinza) package insert (locally hosted backup)]</ref>
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Class/mechanism: Histone deacetylase (HDAC) inhibitor.  Vorinostat inhibits histone deacetylases [http://cancer.sanger.ac.uk/cosmic/gene/overview?ln=HDAC1 HDAC1], [http://cancer.sanger.ac.uk/cosmic/gene/overview?ln=HDAC2 HDAC2], and [http://cancer.sanger.ac.uk/cosmic/gene/overview?ln=HDAC3 HDAC3] (Class  I), as well as [http://cancer.sanger.ac.uk/cosmic/gene/overview?ln=HDAC6 HDAC6] (Class II).  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.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_pi.pdf Vorinostat (Zolinza) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/vorinostat.pdf Vorinostat (Zolinza) package insert (locally hosted backup)]</ref><ref>[http://www.zolinza.com Zolinza manufacturer's site]</ref>
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<br>Route: TBD
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<br>Route: PO
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<br>Extravasation: TBD
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<br>Extravasation: n/a
  
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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 package insert<ref name="insert"></ref>.
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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>  
  
 
==Patient drug information==
 
==Patient drug information==
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*[http://chemocare.com/bio/vorinostat.aspVorinostat (Zolinza) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/vorinostat.aspVorinostat (Zolinza) patient drug information (Chemocare)]</ref>
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*[http://www.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_ppi.pdf Vorinostat (Zolinza) manufacturer's patient drug information]<ref>[http://www.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_ppi.pdf Vorinostat (Zolinza) manufacturer's patient drug information]</ref>
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*[http://chemocare.com/bio/vorinostat.asp Vorinostat (Zolinza) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/vorinostat.asp Vorinostat (Zolinza) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/vorinostat-patient-drug-information Vorinostat (Zolinza) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/vorinostat-patient-drug-information Vorinostat (Zolinza) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/vorinostat-patient-drug-information Vorinostat (Zolinza) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/vorinostat-patient-drug-information Vorinostat (Zolinza) patient drug information (UpToDate)]</ref>
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==Diseases for which it is used==
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*[[Chronic myelomonocytic leukemia]]
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*[[Cutaneous T-cell lymphoma]]
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*[[Diffuse large B-cell lymphoma]]
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*[[Follicular lymphoma]]
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*[[Graft versus host disease]]
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*[[Marginal zone lymphoma]]
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*[[Multiple myeloma]]
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*[[Myelodysplastic syndrome]]
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==Diseases for which it was used==
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*[[Acute myeloid leukemia - historical|Acute myeloid leukemia]]
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*[[Classical Hodgkin lymphoma - historical|Hodgkin lymphoma]]
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==History of changes in FDA indication==
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*2006-10-06: Initial FDA approval: treatment of cutaneous manifestations in patients with [[Cutaneous T-cell lymphoma | cutaneous T-cell lymphoma]] who have progressive, persistent or recurrent disease on or following two systemic therapies. ''(Based on Duvic et al. 2006 & Merck 0683-001)''
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==History of changes in EMA indication==
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*2010-09-20: Orphan designation for the treatment of malignant mesothelioma.
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*2013-03-12: Orphan designation withdrawn.
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==History of changes in Health Canada indication==
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*2009-06-11: Initial notice of compliance
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==History of changes in PMDA indication==
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*2011-07-01: Initial approval for the treatment of [[cutaneous T-cell lymphoma]].
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==Also known as==
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*'''Brand name:''' Zolinza
  
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Drugs]]
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[[Category:Oral medications]]
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[[Category:HDAC inhibitors]]
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[[Category:Chronic myelomonocytic leukemia medications]]
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[[Category:Cutaneous T-cell lymphoma medications]]
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[[Category:Diffuse large B-cell lymphoma medications]]
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[[Category:Follicular lymphoma medications]]
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[[Category:Graft versus host disease medications]]
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[[Category:Marginal zone lymphoma medications]]
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[[Category:Multiple myeloma medications]]
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[[Category:Myelodysplastic syndrome medications]]
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[[Category:Acute myeloid leukemia medications (historic)]]
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[[Category:Classical Hodgkin lymphoma medications (historic)]]
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[[Category:FDA approved in 2006]]
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[[Category:EMA approved in 2010]]
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[[Category:EMA withdrawn in 2013]]
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[[Category:Health Canada approved in 2009]]
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[[Category:PMDA approved in 2011]]

Revision as of 00:20, 7 November 2023

General information

Class/mechanism: Histone deacetylase (HDAC) inhibitor. Vorinostat inhibits histone deacetylases HDAC1, HDAC2, and HDAC3 (Class I), as well as HDAC6 (Class II). 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][3]
Route: PO
Extravasation: n/a

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]

Patient drug information

Diseases for which it is used

Diseases for which it was used

History of changes in FDA indication

  • 2006-10-06: Initial FDA approval: treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. (Based on Duvic et al. 2006 & Merck 0683-001)

History of changes in EMA indication

  • 2010-09-20: Orphan designation for the treatment of malignant mesothelioma.
  • 2013-03-12: Orphan designation withdrawn.

History of changes in Health Canada indication

  • 2009-06-11: Initial notice of compliance

History of changes in PMDA indication

Also known as

  • Brand name: Zolinza

References

  1. ↑ 1.0 1.1 Vorinostat (Zolinza) package insert
  2. ↑ Vorinostat (Zolinza) package insert (locally hosted backup)
  3. ↑ Zolinza manufacturer's site
  4. ↑ Vorinostat (Zolinza) manufacturer's patient drug information
  5. ↑ Vorinostat (Zolinza) patient drug information (Chemocare)
  6. ↑ Vorinostat (Zolinza) patient drug information (UpToDate)
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