Difference between revisions of "Rasburicase (Elitek)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Recombinant urate-oxidase. Rasburicase catalyzes the enzymatic oxidation of poorly soluble uric acid into allantoin, an inactive and more soluble metabolite.<ref name="insert">[http://products.sanofi.us/elitek/elitek.pdf Rasburicase (Elitek) package insert]</ref><ref>[[ | + | Class/mechanism: Recombinant urate-oxidase. Rasburicase catalyzes the enzymatic oxidation of poorly soluble uric acid into allantoin, an inactive and more soluble metabolite.<ref name="insert">[http://products.sanofi.us/elitek/elitek.pdf Rasburicase (Elitek) package insert]</ref><ref>[[:File:Rasburicase.pdf | Rasburicase (Elitek) package insert (locally hosted backup)]]</ref><ref>[http://www.elitek.us/ Elitek 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 such as | + | 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, or the prescribing information.<ref name="insert"></ref> |
==Patient drug information== | ==Patient drug information== | ||
| Line 10: | Line 10: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2002-07-12: Approved for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. |
| − | + | ==History of changes in EMA indication== | |
| + | *2001-02-23: Initial authorization as Fasturtec | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2009-10-16: Initial approval for the treatment of hyperuricemia in patients receiving cancer chemotherapy. | ||
==Also known as== | ==Also known as== | ||
*'''Brand names:''' Elitek, Fasturtec, Rasbelon, Rasburnat, Rasby | *'''Brand names:''' Elitek, Fasturtec, Rasbelon, Rasburnat, Rasby | ||
| Line 21: | Line 24: | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | [[Category: | + | [[Category:Recombinant medications]] |
| − | [[Category: | + | [[Category:Urate oxidase]] |
| − | [[Category: | + | [[Category:EMA approved in 2001]] |
| + | [[Category:FDA approved in 2002]] | ||
| + | [[Category:PMDA approved in 2009]] | ||
| + | [[Category:WHO Essential Cancer Medicine]] | ||
Latest revision as of 00:08, 6 July 2024
General information
Class/mechanism: Recombinant urate-oxidase. Rasburicase catalyzes the enzymatic oxidation of poorly soluble uric acid into allantoin, an inactive and more soluble metabolite.[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 such as Micromedex, Lexicomp, or the prescribing information.[1]
Patient drug information
- Brief patient counseling information can be found in the Rasburicase (Elitek) package insert[1]
History of changes in FDA indication
- 2002-07-12: Approved for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.
History of changes in EMA indication
- 2001-02-23: Initial authorization as Fasturtec
History of changes in PMDA indication
- 2009-10-16: Initial approval for the treatment of hyperuricemia in patients receiving cancer chemotherapy.
Also known as
- Brand names: Elitek, Fasturtec, Rasbelon, Rasburnat, Rasby