Difference between revisions of "Letrozole (Femara)"
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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: Selective non-steroidal aromatase inhibitor. The aromatase enzyme converts adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) in peripheral tissues. Letrozole competitively binds to and inhibits the aromatase by binding to the heme of the enzyme's cytochrome P450.<ref name="insert">[ | + | Class/mechanism: Selective non-steroidal aromatase inhibitor. The aromatase enzyme converts adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) in peripheral tissues. Letrozole competitively binds to and inhibits the aromatase by binding to the heme of the enzyme's cytochrome P450.<ref name="insert">[https://www.novartis.us/sites/www.novartis.us/files/Femara.pdf Letrozole (Femara) package insert]</ref><ref>[[:File:Letrozole.pdf | Letrozole (Femara) package insert (locally hosted backup)]]</ref><ref>[http://www.femara.com Femara manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| − | 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== | ||
*[[Breast_cancer,_ER-positive|ER/PR+ Breast cancer]] | *[[Breast_cancer,_ER-positive|ER/PR+ Breast cancer]] | ||
| + | *[[Low-grade serous ovarian cancer]] | ||
==Patient drug information== | ==Patient drug information== | ||
| Line 15: | Line 16: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *1997-07-25: Initial approval for the treatment of advanced [[breast cancer]] in postmenopausal women |
| − | *10 | + | *2004-10-29: Accelerated approval for the extended adjuvant treatment of early [[breast cancer]] in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy. ''(Indication expanded to adjuvant setting after prior therapy; based on NCIC-CTG MA.17)'' |
| − | ** | + | **2010-04-30: Converted to regular approval. |
| − | *12 | + | *2005-12-28: Accelerated approval for the adjuvant treatment of postmenopausal women with [[Biomarkers#HR|hormone receptor]] [[Biomarkers#Expression|positive]] early [[breast cancer]]. ''(Indication expanded to adjuvant setting; based on BIG 1-98)'' |
| − | ** | + | **2010-04-30: Converted to regular approval. |
| − | * | + | *2010-03-02: Label simplified to adjuvant treatment of postmenopausal women with [[Biomarkers#HR|hormone receptor]] [[Biomarkers#Expression|positive]] early [[breast cancer]]. ''(No change)'' |
| − | * | + | *2010-03-02: Label simplified to extended adjuvant treatment of postmenopausal women with early [[breast cancer]] who have received prior standard adjuvant tamoxifen therapy. ''(Years requirement removed)'' |
| − | * | + | *2010-03-02: Label simplified to first and second-line treatment of postmenopausal women with [[Biomarkers#HR|hormone receptor]] [[Biomarkers#Expression|positive]] or [[Biomarkers#Unknown|unknown]] advanced [[breast cancer]]. ''(Based on ILBCG, AR/BC2, AR/BC3)'' |
| + | ==History of changes in EMA indication== | ||
| + | ''The approval of this drug pre-dates the EMA.'' | ||
| + | *1996-07-24: EURD | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2005-04-01: Initial notice of compliance with conditions | ||
| + | *2010-12-17: Conditions were met | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2006-01-23: Initial approval for the treatment of post-menopausal [[breast cancer]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' CGS 20267 | + | *'''Code name:''' CGS-20267 |
*'''Brand names:''' Femara, Fempro, Gynotril, Latrotal, Lerozol, Letoval, Letpro, Letromina, Letroplex, Letroz, Letrozol, Lexel, Lezole | *'''Brand names:''' Femara, Fempro, Gynotril, Latrotal, Lerozol, Letoval, Letpro, Letromina, Letroplex, Letroz, Letrozol, Lexel, Lezole | ||
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[[Category:Protein expression-specific medications]] | [[Category:Protein expression-specific medications]] | ||
| − | + | [[Category:Aromatase inhibitors, third generation]] | |
| − | [[Category:Aromatase inhibitors]] | ||
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
| + | [[Category:Low-grade serous ovarian cancer medications]] | ||
| + | [[Category:EMA approved in 1996]] | ||
[[Category:FDA approved in 1997]] | [[Category:FDA approved in 1997]] | ||
| + | [[Category:Health Canada approved in 2005]] | ||
| + | [[Category:PMDA approved in 2006]] | ||
Latest revision as of 00:58, 29 June 2024
General information
Class/mechanism: Selective non-steroidal aromatase inhibitor. The aromatase enzyme converts adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) in peripheral tissues. Letrozole competitively binds to and inhibits the aromatase by binding to the heme of the enzyme's cytochrome P450.[1][2][3]
Route: PO
Extravasation: n/a
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
- Letrozole (Femara) package insert[1]
- Letrozole (Femara) patient drug information (Chemocare)[4]
- Letrozole (Femara) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 1997-07-25: Initial approval for the treatment of advanced breast cancer in postmenopausal women
- 2004-10-29: Accelerated approval for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy. (Indication expanded to adjuvant setting after prior therapy; based on NCIC-CTG MA.17)
- 2010-04-30: Converted to regular approval.
- 2005-12-28: Accelerated approval for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. (Indication expanded to adjuvant setting; based on BIG 1-98)
- 2010-04-30: Converted to regular approval.
- 2010-03-02: Label simplified to adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. (No change)
- 2010-03-02: Label simplified to extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. (Years requirement removed)
- 2010-03-02: Label simplified to first and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. (Based on ILBCG, AR/BC2, AR/BC3)
History of changes in EMA indication
The approval of this drug pre-dates the EMA.
- 1996-07-24: EURD
History of changes in Health Canada indication
- 2005-04-01: Initial notice of compliance with conditions
- 2010-12-17: Conditions were met
History of changes in PMDA indication
- 2006-01-23: Initial approval for the treatment of post-menopausal breast cancer.
Also known as
- Code name: CGS-20267
- Brand names: Femara, Fempro, Gynotril, Latrotal, Lerozol, Letoval, Letpro, Letromina, Letroplex, Letroz, Letrozol, Lexel, Lezole