Difference between revisions of "Exemestane (Aromasin)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Steroidal aromatase inhibitor; irreversibly binds and inactivates the aromatase enzyme that converts adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) in peripheral tissues.<ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=523 Exemestane (Aromasin) package insert]</ref><ref>[[ | + | Class/mechanism: Steroidal aromatase inhibitor; irreversibly binds and inactivates the aromatase enzyme that converts adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) in peripheral tissues.<ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=523 Exemestane (Aromasin) package insert]</ref><ref>[[:File:Exemestane.pdf | Exemestane (Aromasin) package insert (locally hosted backup)]]</ref><ref>[http://aromasin.com Aromasin manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
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==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[https://labeling.pfizer.com/ShowLabeling.aspx?id=523 Exemestane (Aromasin) package insert]<ref name="insert"></ref> |
| − | + | *[https://chemocare.com/druginfo/exemestane.aspx Exemestane (Aromasin) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/exemestane.aspx Exemestane (Aromasin) patient drug information (Chemocare)]</ref> | |
| − | *[ | ||
*[http://www.uptodate.com/contents/exemestane-patient-drug-information Exemestane (Aromasin) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/exemestane-patient-drug-information Exemestane (Aromasin) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/exemestane-patient-drug-information Exemestane (Aromasin) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/exemestane-patient-drug-information Exemestane (Aromasin) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 10 | + | * 1999-10-21: Initial FDA approval for the treatment of advanced [[Breast cancer | breast cancer]] in postmenopausal women whose disease has progressed following [[Tamoxifen (Nolvadex) | tamoxifen]] therapy. ''(Based on Kaufmann et al. 2000)'' |
| + | * 2005-10-05: Approved for adjuvant treatment of postmenopausal women with [[Biomarkers#ER|estrogen receptor]] [[Biomarkers#Expression|positive]] early [[breast cancer]] who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy. ''(Based on IES)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | ''The approval of this drug pre-dates the EMA.'' | ||
| + | *1998-12-16: EURD | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2006-05-12: Initial notice of compliance with conditions | ||
| + | *2008-06-08: Conditions were met | ||
==Also known as== | ==Also known as== | ||
| + | *'''Code name:''' FCE-24304 | ||
*'''Brand names:''' Aromadex, Aromasin, Aromex, Xtane | *'''Brand names:''' Aromadex, Aromasin, Aromex, Xtane | ||
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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:FDA approved in 1999]] | [[Category:FDA approved in 1999]] | ||
| − | [[Category: | + | [[Category:EMA approved in 1998]] |
| + | [[Category:Health Canada approved in 2006]] | ||
Revision as of 15:10, 17 November 2023
General information
Class/mechanism: Steroidal aromatase inhibitor; irreversibly binds and inactivates the aromatase enzyme that converts adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) in peripheral tissues.[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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Exemestane (Aromasin) package insert[1]
- Exemestane (Aromasin) patient drug information (Chemocare)[4]
- Exemestane (Aromasin) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 1999-10-21: Initial FDA approval for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. (Based on Kaufmann et al. 2000)
- 2005-10-05: Approved for adjuvant treatment of postmenopausal women with estrogen receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy. (Based on IES)
History of changes in EMA indication
The approval of this drug pre-dates the EMA.
- 1998-12-16: EURD
History of changes in Health Canada indication
- 2006-05-12: Initial notice of compliance with conditions
- 2008-06-08: Conditions were met
Also known as
- Code name: FCE-24304
- Brand names: Aromadex, Aromasin, Aromex, Xtane