Difference between revisions of "Asparaginase Erwinia chrysanthemi (Erwinaze)"
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==Patient drug information== | ==Patient drug information== | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/erwinia-l-asparaginase.aspx Asparaginase patient drug information (Chemocare)] — this is for Asparaginase (Elspar), not Erwinaze<ref>[https://chemocare.com/druginfo/erwinia-l-asparaginase.aspx Asparaginase Erwinia chrysanthemi (Erwinaze) patient drug information (Chemocare)]</ref> |
*Brief patient counseling information can be found on [http://www.erwinaze.com/pdf/PI_18-Nov2011.pdf#page=2 the bottom of page 2 of the package insert]<ref name="insert"></ref> | *Brief patient counseling information can be found on [http://www.erwinaze.com/pdf/PI_18-Nov2011.pdf#page=2 the bottom of page 2 of the package insert]<ref name="insert"></ref> | ||
*[http://www.uptodate.com/contents/erwinia-asparaginase-patient-drug-information Asparaginase Erwinia chrysanthemi (Erwinaze) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/erwinia-asparaginase-patient-drug-information Asparaginase Erwinia chrysanthemi (Erwinaze) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/erwinia-asparaginase-patient-drug-information Asparaginase Erwinia chrysanthemi (Erwinaze) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/erwinia-asparaginase-patient-drug-information Asparaginase Erwinia chrysanthemi (Erwinaze) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 2011-11-18: Initial FDA approval as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with [[:Category:Acute lymphoblastic leukemias| acute lymphoblastic leukemia (ALL)]] who have developed hypersensitivity to [[Asparaginase (Elspar) | E. coli-derived asparaginase]]. ''(Based on COG AALL07P2 | + | * 2011-11-18: Initial FDA approval as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with [[:Category:Acute lymphoblastic leukemias| acute lymphoblastic leukemia (ALL)]] who have developed hypersensitivity to [[Asparaginase (Elspar) | E. coli-derived asparaginase]]. ''(Based on COG AALL07P2)'' |
==History of changes in PMDA indication== | ==History of changes in PMDA indication== | ||
*2016-12-19: Initial approval for the treatment of [[:Category:Acute leukemias|acute leukemia]] (including blast crisis of chronic leukemia) and [[:Category:Lymphomas|malignant lymphoma]] (only for patients who experienced hypersensitivity to L-asparaginase preparations). | *2016-12-19: Initial approval for the treatment of [[:Category:Acute leukemias|acute leukemia]] (including blast crisis of chronic leukemia) and [[:Category:Lymphomas|malignant lymphoma]] (only for patients who experienced hypersensitivity to L-asparaginase preparations). | ||
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==References== | ==References== | ||
<references/> | <references/> | ||
| + | #'''COG AALL07P2:''' Salzer WL, Asselin B, Supko JG, Devidas M, Kaiser NA, Plourde P, Winick NJ, Reaman GH, Raetz E, Carroll WL, Hunger SP. Erwinia asparaginase achieves therapeutic activity after pegaspargase allergy: a report from the Children's Oncology Group. Blood. 2013 Jul 25;122(4):507-14. Epub 2013 Jun 5. [https://doi.org/10.1182/blood-2013-01-480822 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc3724190/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23741010/ PubMed] [https://www.clinicaltrials.gov/study/NCT00537030 NCT00537030] | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
Revision as of 23:27, 2 September 2023
General information
Class/mechanism: Depletes plasma asparagine by catalyzing the deamidation of asparagine to
aspartic acid and ammonia, selectively killing leukemic cells which are unable to synthesize asparagine due to a lack of asparagine synthetase.[1][2][3]
Route: IM
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, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
- B-cell acute lymphoblastic leukemia
- Extranodal NK- and T-cell lymphoma, nasal type
- NK- and T-cell lymphoma
- T-cell acute lymphoblastic leukemia
Patient drug information
- Asparaginase patient drug information (Chemocare) — this is for Asparaginase (Elspar), not Erwinaze[4]
- Brief patient counseling information can be found on the bottom of page 2 of the package insert[1]
- Asparaginase Erwinia chrysanthemi (Erwinaze) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2011-11-18: Initial FDA approval as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. (Based on COG AALL07P2)
History of changes in PMDA indication
- 2016-12-19: Initial approval for the treatment of acute leukemia (including blast crisis of chronic leukemia) and malignant lymphoma (only for patients who experienced hypersensitivity to L-asparaginase preparations).
Also known as
- Generic names: crisantaspasum, crisantaspase, Erwinia L-asparginase, krisantaspaasi, krisantaspas
- Brand names: Erwinase, Erwinaze
References
- ↑ 1.0 1.1 1.2 Asparaginase Erwinia chrysanthemi (Erwinaze) package insert
- ↑ Asparaginase Erwinia chrysanthemi (Erwinaze) package insert (locally hosted backup)
- ↑ Erwinaze manufacturer's website
- ↑ Asparaginase Erwinia chrysanthemi (Erwinaze) patient drug information (Chemocare)
- ↑ Asparaginase Erwinia chrysanthemi (Erwinaze) patient drug information (UpToDate)
- COG AALL07P2: Salzer WL, Asselin B, Supko JG, Devidas M, Kaiser NA, Plourde P, Winick NJ, Reaman GH, Raetz E, Carroll WL, Hunger SP. Erwinia asparaginase achieves therapeutic activity after pegaspargase allergy: a report from the Children's Oncology Group. Blood. 2013 Jul 25;122(4):507-14. Epub 2013 Jun 5. link to original article link to PMC article PubMed NCT00537030