Difference between revisions of "Clofarabine (Clolar)"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
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")
 
(34 intermediate revisions by 5 users not shown)
Line 1: Line 1:
−
Also known as Evoltra.
 
−
 
 
==General information==
 
==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.<ref name="insert">[http://www.clolar.com/~/media/Files/Clolar/prescribing-information.pdf Clofarabine (Clolar) package insert]</ref><ref>[[Media:Clofarabine.pdf | Clofarabine (Clolar) package insert (locally hosted backup)]]</ref><ref>[http://clolar.com Clolar manufacturer's website]</ref>
+
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
+
<br>Route: IV, PO
−
<br>Extravasation: no information
+
<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 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>  
+
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==
−
*[[Acute lymphocytic leukemia]]
+
*[[:Category:Acute lymphoblastic leukemias |Acute lymphoblastic leukemia]]
 +
*[[Acute myeloid leukemia]]
 
*[[Myelodysplastic syndrome]]
 
*[[Myelodysplastic syndrome]]
  
 
==Patient drug information==
 
==Patient drug information==
−
*Brief patient counseling information can be found at the bottom of [http://www.clolar.com/~/media/Files/Clolar/prescribing-information.pdf#page=2 page 2 of the package insert]<ref name="insert"></ref>
+
*Brief patient counseling information can be found at the bottom of [https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=55d3c78b-dca5-436b-97b5-73d166217415#page=2 page 2 of the package insert]<ref name="insert"></ref>
 
*[http://www.uptodate.com/contents/clofarabine-patient-drug-information Clofarabine (Clolar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/clofarabine-patient-drug-information Clofarabine (Clolar) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/clofarabine-patient-drug-information Clofarabine (Clolar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/clofarabine-patient-drug-information Clofarabine (Clolar) patient drug information (UpToDate)]</ref>
 +
 +
==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 [[: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==
 +
*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==
 +
*'''Generic name:''' klofarabin
 +
*'''Brand names:''' Clolar, Evoltra, Evorabin, Ivozall
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
+
[[Category:Drugs]]
−
[[Category:Chemotherapy]]
+
 
−
[[Category:Nucleic acid analogs]]
+
[[Category:Intravenous medications]]
−
[[Category:Acute lymphocytic leukemia medications]]
+
[[Category:Neutral]]
 +
[[Category:Oral medications]]
 +
 
 +
[[Category:Antimetabolites]]
 +
[[Category:Purine analogs]]
 +
 
 +
[[Category:B-cell acute lymphoblastic leukemia medications]]
 +
[[Category:T-cell acute lymphoblastic leukemia medications]]
 +
[[Category:Acute myeloid leukemia medications]]
 +
[[Category:Myelodysplastic syndrome medications]]
 +
 
 +
[[Category:FDA approved in 2004]]
 +
[[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

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

Also known as

  • Generic name: klofarabin
  • Brand names: Clolar, Evoltra, Evorabin, Ivozall

References

  1. ↑ 1.0 1.1 1.2 Clofarabine (Clolar) package insert
  2. ↑ Clofarabine (Clolar) package insert (locally hosted backup)
  3. ↑ Clolar manufacturer's website
  4. ↑ Clofarabine (Clolar) patient drug information (UpToDate)
Retrieved from "https://hemonc.org/w/index.php?title=Clofarabine_(Clolar)&oldid=87334"