Difference between revisions of "Levoleucovorin (Fusilev)"

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==General information==
 
==General information==
Class/mechanism: Folic acid analog that is the pharmacologically active isomer of 5-formyl tetrahydrofolic acid (racemic d,l [[Folinic acid (Leucovorin)]]).  Counteracts the effects of folic acid antagonists such as [[Methotrexate (MTX) | methotrexate]], which acts by inhibiting dihydrofolate reductase.  Enhances the activity of [[Fluorouracil (5-FU)]] by inhibiting thymidylate synthase.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf Levoleucovorin (Fusilev) package insert]</ref><ref>[[:File:Levoleucovorin.pdf | Levoleucovorin (Fusilev) package insert (locally hosted backup)]]</ref><ref>[http://fusilev.com/ Fusilev manufacturer's website]</ref>
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Class/mechanism: Folic acid analog that is the pharmacologically active isomer of 5-formyl tetrahydrofolic acid (racemic d,l [[Leucovorin (Folinic acid)]]).  Counteracts the effects of folic acid antagonists such as [[Methotrexate (MTX) | methotrexate]], which acts by inhibiting dihydrofolate reductase.  Enhances the activity of [[Fluorouracil (5-FU)]] by inhibiting thymidylate synthase.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf Levoleucovorin (Fusilev) package insert]</ref><ref>[[:File:Levoleucovorin.pdf | Levoleucovorin (Fusilev) package insert (locally hosted backup)]]</ref><ref>[http://fusilev.com/ Fusilev 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 [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==
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*[[Cervical cancer]] ‎  
 
*[[Cervical cancer]] ‎  
 
*[[Cholangiocarcinoma]]
 
*[[Cholangiocarcinoma]]
*[[Colon cancer]]
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*[[Colorectal cancer]]
*[[Esophageal cancer]] ‎  
+
**[[Colon cancer]]
 +
**[[Rectal cancer]]
 +
*[[Esophageal cancer]] ‎
 +
**[[Esophageal adenocarcinoma]]
 
*[[Gastric cancer]] ‎  
 
*[[Gastric cancer]] ‎  
 
*[[Hepatocellular carcinoma]] ‎  
 
*[[Hepatocellular carcinoma]] ‎  
*[[Pancreatic cancer]] ‎  
+
*[[Pancreatic cancer]] ‎ 
*[[Rectal cancer]]
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*[[Small bowel adenocarcinoma]]
  
 
==Patient drug information==
 
==Patient drug information==
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==History of changes in FDA indication==
 
==History of changes in FDA indication==
*3/7/2008: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf FDA approved] "to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists." "Levoleucovorin rescue is indicated after high-dose methotrexate therapy in [[Bone sarcoma | osteosarcoma]]."
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*2008-03-07: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf FDA approved] "to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists." "Levoleucovorin rescue is indicated after high-dose methotrexate therapy in [[Bone sarcoma | osteosarcoma]]."
 +
==History of changes in PMDA indication==
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*2013-12-20: New additional indication and a new dosage for the treatment of unresectable [[pancreatic cancer]].
 +
*2018-09-21: New indication and a new dosage for the treatment of [[small bowel adenocarcinoma|small intestine cancer]].
  
 
==Also known as==
 
==Also known as==
 
*'''Generic name:''' levoleucovorin calcium
 
*'''Generic name:''' levoleucovorin calcium
*'''Brand name:''' Fusilev
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*'''Brand name:''' Fusilev, Isovorin
  
 
==References==
 
==References==
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[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
  
 +
[[Category:Folic acid analog]]
 
[[Category:Chemotherapy protective agents]]
 
[[Category:Chemotherapy protective agents]]
  
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[[Category:Cholangiocarcinoma medications]]
 
[[Category:Cholangiocarcinoma medications]]
 
[[Category:Colon cancer medications]] ‎
 
[[Category:Colon cancer medications]] ‎
 +
[[Category:Colorectal cancer medications]]
 +
[[Category:Esophageal adenocarcinoma medications]]
 
[[Category:Esophageal cancer medications]]
 
[[Category:Esophageal cancer medications]]
 
[[Category:Gastric cancer medications]]
 
[[Category:Gastric cancer medications]]
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[[Category:Pancreatic cancer medications]]
 
[[Category:Pancreatic cancer medications]]
 
[[Category:Rectal cancer medications]] ‎
 
[[Category:Rectal cancer medications]] ‎
 +
[[Category:Small bowel adenocarcinoma medications]]
  
 
[[Category:FDA approved in 2008]]
 
[[Category:FDA approved in 2008]]

Latest revision as of 01:06, 29 June 2024

General information

Class/mechanism: Folic acid analog that is the pharmacologically active isomer of 5-formyl tetrahydrofolic acid (racemic d,l Leucovorin (Folinic acid)). Counteracts the effects of folic acid antagonists such as methotrexate, which acts by inhibiting dihydrofolate reductase. Enhances the activity of Fluorouracil (5-FU) by inhibiting thymidylate synthase.[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]

Diseases for which it is used

Note: these are diseases where folinic acid is used as an adjuvant to Fluorouracil (5-FU), as opposed to an antidote as it is used in conjunction with Methotrexate (MTX)

Patient drug information

History of changes in FDA indication

  • 2008-03-07: FDA approved "to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists." "Levoleucovorin rescue is indicated after high-dose methotrexate therapy in osteosarcoma."

History of changes in PMDA indication

  • 2013-12-20: New additional indication and a new dosage for the treatment of unresectable pancreatic cancer.
  • 2018-09-21: New indication and a new dosage for the treatment of small intestine cancer.

Also known as

  • Generic name: levoleucovorin calcium
  • Brand name: Fusilev, Isovorin

References

‎ ‎