Difference between revisions of "Glucarpidase (Voraxaze)"
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Warner-admin (talk | contribs) m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information") |
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==General information== | ==General information== | ||
| − | Class/mechanism: Recombinant bacterial enzyme that degrades folic acid and antifolates such as [[Methotrexate (MTX)|methotrexate]] by hydrolyzing their carboxyl-terminal glutamate residues. | + | Class/mechanism: Recombinant bacterial enzyme that degrades folic acid and antifolates such as [[Methotrexate (MTX)|methotrexate]] by hydrolyzing their carboxyl-terminal glutamate residues. Glucarpidase catalyzes the degradation of methotrexate to the inactive metabolites 4-deoxy-4-amino-N10-methylpteroic acid (DAMPA) and glutamate.<ref name="insert">[https://www.btgplc.com/media/1213/voraxaze-prescribing-information-march-13-1.pdf Glucarpidase (Voraxaze) package insert]</ref><ref>[[:File:Glucarpidase.pdf|Glucarpidase (Voraxaze) package insert (locally hosted backup)]]</ref><ref>[http://www.btgplc.com/products/specialty-pharmaceuticals/voraxaze Glucarpidase (Voraxaze) manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <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. Instead, for the most current information, please refer to your preferred pharmacopeias | + | 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 or the prescribing information.<ref name="insert"></ref> |
==Patient drug information== | ==Patient drug information== | ||
| Line 11: | Line 11: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 2012-01-17: Initial FDA approval for the treatment of toxic plasma [[Methotrexate (MTX)|methotrexate]] concentrations (greater than 1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. |
| − | + | ==History of changes in PMDA indication== | |
| + | *2021-09-27: Newly indicated to reduce toxic plasma methotrexate concentration in patients with delayed clearance of methotrexate due to methotrexate/leucovorin salvage therapy. | ||
==Also known as== | ==Also known as== | ||
*'''Generic name:''' carboxypeptidase G2 | *'''Generic name:''' carboxypeptidase G2 | ||
| − | *'''Brand | + | *'''Brand names:''' Megludase, Voraxaze |
| + | |||
==References== | ==References== | ||
<references/> | <references/> | ||
| − | # Buchen S, Ngampolo D, Melton RG, Hasan C, Zoubek A, Henze G, Bode U, Fleischhack G. Carboxypeptidase G2 rescue in patients with methotrexate intoxication and renal failure. Br J Cancer. 2005 Feb 14;92(3):480-7. [https:// | + | # Buchen S, Ngampolo D, Melton RG, Hasan C, Zoubek A, Henze G, Bode U, Fleischhack G. Carboxypeptidase G2 rescue in patients with methotrexate intoxication and renal failure. Br J Cancer. 2005 Feb 14;92(3):480-7. [https://doi.org/10.1038/sj.bjc.6602337 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362096/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/15668713/ PubMed] |
[[Category:Drugs]] | [[Category:Drugs]] | ||
| Line 25: | Line 27: | ||
[[Category:FDA approved in 2012]] | [[Category:FDA approved in 2012]] | ||
| + | [[Category:PMDA approved in 2021]] | ||
Latest revision as of 00:59, 29 June 2024
General information
Class/mechanism: Recombinant bacterial enzyme that degrades folic acid and antifolates such as methotrexate by hydrolyzing their carboxyl-terminal glutamate residues. Glucarpidase catalyzes the degradation of methotrexate to the inactive metabolites 4-deoxy-4-amino-N10-methylpteroic acid (DAMPA) and glutamate.[1][2][3]
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 or the prescribing information.[1]
Patient drug information
- Brief patient counseling information can be found in the package insert.[1]
- Glucarpidase (Voraxaze) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 2012-01-17: Initial FDA approval for the treatment of toxic plasma methotrexate concentrations (greater than 1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.
History of changes in PMDA indication
- 2021-09-27: Newly indicated to reduce toxic plasma methotrexate concentration in patients with delayed clearance of methotrexate due to methotrexate/leucovorin salvage therapy.
Also known as
- Generic name: carboxypeptidase G2
- Brand names: Megludase, Voraxaze
References
- Buchen S, Ngampolo D, Melton RG, Hasan C, Zoubek A, Henze G, Bode U, Fleischhack G. Carboxypeptidase G2 rescue in patients with methotrexate intoxication and renal failure. Br J Cancer. 2005 Feb 14;92(3):480-7. link to original article link to PMC article PubMed