Difference between revisions of "Pegaspargase (Oncaspar)"

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Also known as PEG-L-asparaginase, Peg-asparginase, Pegasparaginase.
 
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==General information==
 
==General information==
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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://oncaspar.com/pdf/OncasparPI.pdf Pegaspargase (Oncaspar) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/pegaspargase.pdf Pegaspargase (Oncaspar) 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>
 
<br>Route: IV, IM
 
<br>Route: IV, IM
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<br>Extravasation: no information
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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 prescribing information.<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>  
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
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''No regimen currently listed on HemOnc.org directly references this drug. However, it is often substituted for [[Asparaginase (Elspar) | L-asparaginase]] in many chemotherapy regimens, due to ease of administration.''
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*[[B-cell acute lymphoblastic leukemia]]
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*[[Acute lymphocytic leukemia]]
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*[[Extranodal NK- and T-cell lymphoma, nasal type]]
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*[[T-cell lymphoma]]
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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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==History of changes in FDA indication==
 
==History of changes in FDA indication==
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* 2/1/1994: Initial FDA approval
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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:Drug index]]
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[[Category:Drugs]]
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[[Category:Chemotherapy]]
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[[Category:Pegylated medications]]
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[[Category:Intramuscular chemotherapy]]
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[[Category:Intravenous chemotherapy]]
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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:Enzymes]]
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[[Category:FDA approved in 1994]]
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[[Category:Acute lymphocytic leukemia medications]]
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[[Category:EMA approved in 2016]]
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[[Category:T-cell lymphoma medications]]
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[[Category:PMDA approved in 2023]]
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[[Category:Drugs FDA approved in 1994]]
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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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