Difference between revisions of "Clofarabine (Clolar)"
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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: Purine analog, inhibits DNA synthesis and repair by inhibiting ribonucleotide reductase and competitively inhibiting DNA polymerases. | + | Class/mechanism: Purine analog, inhibits DNA synthesis and repair by inhibiting ribonucleotide reductase and competitively inhibiting DNA polymerases. It also causes apoptosis by disrupting the integrity of the mitochondrial membrane, triggering the release of cytochrome C and apoptosis-inducing factor, which are pro-apoptotic mitochondrial proteins.<ref name="insert">[https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=55d3c78b-dca5-436b-97b5-73d166217415 Clofarabine (Clolar) package insert]</ref><ref>[[:File:Clofarabine.pdf | Clofarabine (Clolar) package insert (locally hosted backup)]]</ref><ref>[http://clolar.com Clolar manufacturer's website]</ref> |
<br>Route: IV, PO | <br>Route: IV, PO | ||
<br>Extravasation: [[neutral]] | <br>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 | + | 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> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 16: | Line 16: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 12 | + | * 2004-12-28: Accelerated approval for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory [[:Category:Acute lymphoblastic leukemias | acute lymphoblastic leukemia]] after at least two prior regimens. ''(Based on Jeha et al. 2003 & CLO212)'' |
| + | **2022-07-18: Converted to regular approval | ||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2006-05-29: Initial authorization as Evoltra |
| + | ==History of changes in Health Canada indication== | ||
| + | *2009-07-16: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2013-03-25: Initial approval for the treatment of recurrent or refractory [[:Category:Acute lymphoblastic leukemias | acute lymphoblastic leukemia]]. | ||
==Also known as== | ==Also known as== | ||
*'''Generic name:''' klofarabin | *'''Generic name:''' klofarabin | ||
| − | *'''Brand names:''' Clolar, Evoltra, Evorabin | + | *'''Brand names:''' Clolar, Evoltra, Evorabin, Ivozall |
==References== | ==References== | ||
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[[Category:Antimetabolites]] | [[Category:Antimetabolites]] | ||
| − | [[Category:Purine | + | [[Category:Purine analogs]] |
[[Category:B-cell acute lymphoblastic leukemia medications]] | [[Category:B-cell acute lymphoblastic leukemia medications]] | ||
| Line 42: | Line 47: | ||
[[Category:FDA approved in 2004]] | [[Category:FDA approved in 2004]] | ||
[[Category:EMA approved in 2006]] | [[Category:EMA approved in 2006]] | ||
| + | [[Category:Health Canada approved in 2009]] | ||
| + | [[Category:PMDA approved in 2013]] | ||
Latest revision as of 01:03, 29 June 2024
General information
Class/mechanism: Purine analog, inhibits DNA synthesis and repair by inhibiting ribonucleotide reductase and competitively inhibiting DNA polymerases. It also causes apoptosis by disrupting the integrity of the mitochondrial membrane, triggering the release of cytochrome C and apoptosis-inducing factor, which are pro-apoptotic mitochondrial proteins.[1][2][3]
Route: IV, PO
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 or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Brief patient counseling information can be found at the bottom of page 2 of the package insert[1]
- Clofarabine (Clolar) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 2004-12-28: Accelerated approval for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. (Based on Jeha et al. 2003 & CLO212)
- 2022-07-18: Converted to regular approval
History of changes in EMA indication
- 2006-05-29: Initial authorization as Evoltra
History of changes in Health Canada indication
- 2009-07-16: Initial notice of compliance
History of changes in PMDA indication
- 2013-03-25: Initial approval for the treatment of recurrent or refractory acute lymphoblastic leukemia.
Also known as
- Generic name: klofarabin
- Brand names: Clolar, Evoltra, Evorabin, Ivozall
References
Categories:
- Drugs
- Intravenous medications
- Neutral
- Oral medications
- Antimetabolites
- Purine analogs
- B-cell acute lymphoblastic leukemia medications
- T-cell acute lymphoblastic leukemia medications
- Acute myeloid leukemia medications
- Myelodysplastic syndrome medications
- FDA approved in 2004
- EMA approved in 2006
- Health Canada approved in 2009
- PMDA approved in 2013