Difference between revisions of "Pegaspargase (Oncaspar)"

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(Created page with "==General information== Class/mechanism: <ref name="insert">[http://oncaspar.com/pdf/OncasparPI.pdf Peg-asparginase (Oncospar) package insert]</ref><ref>[http://hemonc.org/docs/p...")
 
 
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==General information==
 
==General information==
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Class/mechanism: <ref name="insert">[http://oncaspar.com/pdf/OncasparPI.pdf Peg-asparginase (Oncospar) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/pegasparginase.pdf Peg-asparginase (Oncospar) package insert (locally hosted backup)]</ref>
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Class/mechanism: Depletes plasma asparagine, selectively killing leukemic cells which are unable to synthesize asparagine due to a lack of asparagine synthetase.  The Oncaspar formulation involves L-asparaginase (L-asparagine amidohydrolase) being covalently conjugated to monomethoxypolyethylene glycol (mPEG), increasing its half-life and reducing the risk of hypersensitivity reactions in patients who have history of hypersensitivity to [[Asparaginase (Elspar)]].<ref name="insert">[http://www.shirecontent.com/PI/PDFs/ONCASPAR_USA_ENG.pdf Pegaspargase (Oncaspar) package insert]</ref><ref>[[:File:Pegaspargase.pdf | Pegaspargase (Oncaspar) package insert (locally hosted backup)]]</ref>
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<br>Route: TBD
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<br>Route: IV, IM
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<br>Extravasation: TBD
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<br>Extravasation: [[neutral]]
  
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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>  
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==Diseases for which it is used==
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*[[B-cell acute lymphoblastic leukemia]]
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*[[Extranodal NK- and T-cell lymphoma, nasal type]]
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*[[NK- and T-cell lymphoma]]
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*[[T-cell acute lymphoblastic leukemia]]
  
 
==Patient drug information==
 
==Patient drug information==
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*[http://chemocare.com/bio/peglasparaginase.asp Peg-asparginase (Oncospar) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/peglasparaginase.asp Peg-asparginase (Oncospar) patient drug information (Chemocare)]</ref>
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*[http://chemocare.com/bio/peglasparaginase.asp Pegaspargase (Oncaspar) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/peglasparaginase.asp Pegaspargase (Oncaspar) patient drug information (Chemocare)]</ref>
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*[http://www.uptodate.com/contents/pegasparginase-patient-drug-information Peg-asparginase (Oncospar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/pegasparginase-patient-drug-information Peg-asparginase (Oncospar) patient drug information (UpToDate)]</ref>
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*[http://www.uptodate.com/contents/pegaspargase-patient-drug-information Pegaspargase (Oncaspar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/pegaspargase-patient-drug-information Pegaspargase (Oncaspar) patient drug information (UpToDate)]</ref>
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==History of changes in FDA indication==
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* 1994-02-01: Initial FDA approval for treatment of [[:Category:Acute lymphoblastic leukemias|acute lymphocytic leukemia (ALL)]] in patients who require L-asparaginase in their treatment regimen but have developed hypersensitivity to the native forms of L-asparaginase. ''(Based on CCG 1962)''
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* 2006-07-24: FDA approved for the first-line treatment of patients with [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]]. ''(Based on CCG 1962)''
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==History of changes in EMA indication==
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*2016-01-14: Initial authorization
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==History of changes in PMDA indication==
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*2023-06-26: A drug with a new active ingredient indicated for the treatment of [[:Category:Acute lymphoblastic leukemias|acute lymphocytic leukemia]].
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*2023-06-26: A drug with a new active ingredient indicated for the treatment of [[:Category:Lymphomas|malignant lymphoma]].
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==Also known as==
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*'''Generic names:''' PEG-L-asparaginase, peg-asparginase, pegasparaginase
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*'''Brand name:''' Oncaspar
  
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Drugs]]
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[[Category:Pegylated medications]]
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[[Category:Intramuscular medications]]
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[[Category:Intravenous medications]]
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[[Category:Neutral]]
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[[Category:Asparagine-specific enzymes]]
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[[Category:B-cell acute lymphoblastic leukemia medications]]
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[[Category:Extranodal NK- and T-cell lymphoma, nasal type medications]]
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[[Category:NK- and T-cell lymphoma medications]]
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[[Category:T-cell acute lymphoblastic leukemia medications]]
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[[Category:FDA approved in 1994]]
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[[Category:EMA approved in 2016]]
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[[Category:PMDA approved in 2023]]
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[[Category:WHO Essential Cancer Medicine]]

Latest revision as of 03:48, 1 June 2024

General information

Class/mechanism: Depletes plasma asparagine, selectively killing leukemic cells which are unable to synthesize asparagine due to a lack of asparagine synthetase. The Oncaspar formulation involves L-asparaginase (L-asparagine amidohydrolase) being covalently conjugated to monomethoxypolyethylene glycol (mPEG), increasing its half-life and reducing the risk of hypersensitivity reactions in patients who have history of hypersensitivity to Asparaginase (Elspar).[1][2]
Route: IV, IM
Extravasation: neutral

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

History of changes in FDA indication

  • 1994-02-01: Initial FDA approval for treatment of acute lymphocytic leukemia (ALL) in patients who require L-asparaginase in their treatment regimen but have developed hypersensitivity to the native forms of L-asparaginase. (Based on CCG 1962)
  • 2006-07-24: FDA approved for the first-line treatment of patients with acute lymphoblastic leukemia. (Based on CCG 1962)

History of changes in EMA indication

  • 2016-01-14: Initial authorization

History of changes in PMDA indication

Also known as

  • Generic names: PEG-L-asparaginase, peg-asparginase, pegasparaginase
  • Brand name: Oncaspar

References

  1. ↑ 1.0 1.1 Pegaspargase (Oncaspar) package insert
  2. ↑ Pegaspargase (Oncaspar) package insert (locally hosted backup)
  3. ↑ Pegaspargase (Oncaspar) patient drug information (Chemocare)
  4. ↑ Pegaspargase (Oncaspar) patient drug information (UpToDate)
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