Difference between revisions of "Pralatrexate (Folotyn)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Folate analog, antimetabolite, competitive inhibitor of dihydrofolate reductase. Also competitively inhibits polyglutamylation by folylpolyglutamyl synthetase and causes depletion of thymidine.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf Pralatrexate (Folotyn) package insert]</ref><ref>[ | + | Class/mechanism: Folate analog, antimetabolite, competitive inhibitor of dihydrofolate reductase. Also competitively inhibits polyglutamylation by folylpolyglutamyl synthetase and causes depletion of thymidine.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf Pralatrexate (Folotyn) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/pralatrexate.pdf Pralatrexate (Folotyn) package insert (locally hosted backup)]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
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*Vitamin B12 1000mcg should be given no less than 10 weeks before the first dose of Pralatrexate (Folotyn) and then every 8 to 10 weeks thereafter. | *Vitamin B12 1000mcg should be given no less than 10 weeks before the first dose of Pralatrexate (Folotyn) and then every 8 to 10 weeks thereafter. | ||
| − | 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> |
| + | |||
| + | ==Diseases for which it is established== | ||
| + | *[[Peripheral T-cell lymphoma]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Cutaneous T-cell lymphoma]] | *[[Cutaneous T-cell lymphoma]] | ||
| − | |||
==Patient drug information== | ==Patient drug information== | ||
| Line 18: | Line 20: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2009-09-24: Accelerated approval for the treatment of patients with relapsed or refractory [[Peripheral_T-cell_lymphoma|peripheral T-cell lymphoma (PTCL)]]. ''(Based on PROPEL)'' |
| − | + | ==History of changes in Health Canada indication== | |
| + | *2018-10-26: Initial notice of compliance with conditions for the treatment of patients with relapsed or refractory [[Peripheral_T-cell_lymphoma|peripheral T-cell lymphoma (PTCL)]]. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2017-07-03: New approval for the treatment of relapsed or refractory [[peripheral T-cell lymphoma]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Brand | + | *'''Brand names:''' Difolta, Folotyn |
==References== | ==References== | ||
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[[Category:Peripheral T-cell lymphoma medications]] | [[Category:Peripheral T-cell lymphoma medications]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2009]] |
| + | [[Category:Health Canada approved in 2018]] | ||
| + | [[Category:PMDA approved in 2017]] | ||
Latest revision as of 00:15, 6 July 2024
General information
Class/mechanism: Folate analog, antimetabolite, competitive inhibitor of dihydrofolate reductase. Also competitively inhibits polyglutamylation by folylpolyglutamyl synthetase and causes depletion of thymidine.[1][2]
Route: IV
Extravasation: no information
Supportive care examples:[1]
- Patients should take daily folic acid (example dose: 1 to 1.25 mg PO once per day) starting in the 10-day period before starting therapy, during therapy, and for 30 days after the last dose of Pralatrexate (Folotyn).
- Vitamin B12 1000mcg should be given no less than 10 weeks before the first dose of Pralatrexate (Folotyn) and then every 8 to 10 weeks thereafter.
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]
Diseases for which it is established
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2009-09-24: Accelerated approval for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). (Based on PROPEL)
History of changes in Health Canada indication
- 2018-10-26: Initial notice of compliance with conditions for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
History of changes in PMDA indication
- 2017-07-03: New approval for the treatment of relapsed or refractory peripheral T-cell lymphoma.
Also known as
- Brand names: Difolta, Folotyn