Difference between revisions of "Levoleucovorin (Fusilev)"

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m (Text replace - "package insert<ref name="insert"></ref>." to "prescribing information.<ref name="insert"></ref>")
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==
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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, which acts by inhibiting dihydrofolate reductase.  Enhances the activity of [[Fluorouracil (5-FU)]] by inhibiting thymidylate synthase.<ref name="insert">[http://www.fusilev.com/downloads/m1-14-1-3-1125-000503-clean.pdf Levoleucovorin (Fusilev) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/levoleucovorin.pdf Levoleucovorin (Fusilev) package insert (locally hosted backup)]</ref><ref>[http://www.fusilev.com/index.html 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
  
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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>
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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>
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==Diseases for which it is used==
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''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)]]''
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*[[Cervical cancer]] ‎
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*[[Cholangiocarcinoma]]
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*[[Colorectal cancer]]
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**[[Colon cancer]]
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**[[Rectal cancer]]
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*[[Esophageal cancer]] ‎
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**[[Esophageal adenocarcinoma]]
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*[[Gastric cancer]] ‎
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*[[Hepatocellular carcinoma]] ‎
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*[[Pancreatic cancer]] ‎  ‎
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*[[Small bowel adenocarcinoma]]
  
 
==Patient drug information==
 
==Patient drug information==
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*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf Levoleucovorin (Fusilev) package insert]<ref name="insert"></ref>
 
*[http://www.uptodate.com/contents/levoleucovorin-patient-drug-information Levoleucovorin (Fusilev) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/levoleucovorin-patient-drug-information Levoleucovorin (Fusilev) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/levoleucovorin-patient-drug-information Levoleucovorin (Fusilev) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/levoleucovorin-patient-drug-information Levoleucovorin (Fusilev) patient drug information (UpToDate)]</ref>
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==History of changes in FDA indication==
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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]]."
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==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]].
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*2018-09-21: New indication and a new dosage for the treatment of [[small bowel adenocarcinoma|small intestine cancer]].
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==Also known as==
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*'''Generic name:''' levoleucovorin calcium
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*'''Brand name:''' Fusilev, Isovorin
  
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Drugs]]
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[[Category:Intravenous medications]]
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[[Category:Folic acid analog]]
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[[Category:Chemotherapy protective agents]]
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[[Category:Cervical cancer medications]]
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[[Category:Cholangiocarcinoma medications]]
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[[Category:Colon cancer medications]] ‎
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[[Category:Colorectal cancer medications]]
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[[Category:Esophageal adenocarcinoma medications]]
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[[Category:Esophageal cancer medications]]
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[[Category:Gastric cancer medications]]
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[[Category:Hepatocellular carcinoma medications]]
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[[Category:Pancreatic cancer medications]]
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[[Category:Rectal cancer medications]] ‎
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[[Category:Small bowel adenocarcinoma medications]]
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[[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

  1. ↑ 1.0 1.1 1.2 Levoleucovorin (Fusilev) package insert
  2. ↑ Levoleucovorin (Fusilev) package insert (locally hosted backup)
  3. ↑ Fusilev manufacturer's website
  4. ↑ Levoleucovorin (Fusilev) patient drug information (UpToDate)

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