Difference between revisions of "Anastrozole (Arimidex)"
m |
|||
| Line 22: | Line 22: | ||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
''The approval of this drug pre-dates the EMA.'' | ''The approval of this drug pre-dates the EMA.'' | ||
| + | *1995-08-11: EURD | ||
==History of changes in Health Canada indication== | ==History of changes in Health Canada indication== | ||
*2004-06-30: Initial notice of compliance with conditions | *2004-06-30: Initial notice of compliance with conditions | ||
| Line 41: | Line 42: | ||
[[Category:Endometrial cancer medications]] | [[Category:Endometrial cancer medications]] | ||
[[Category:FDA approved in 1995]] | [[Category:FDA approved in 1995]] | ||
| + | [[Category:EMA approved in 1995]] | ||
[[Category:Health Canada approved in 2004]] | [[Category:Health Canada approved in 2004]] | ||
[[Category:WHO Essential Cancer Medicine]] | [[Category:WHO Essential Cancer Medicine]] | ||
Revision as of 01:31, 13 June 2023
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.[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, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Anastrozole (Arimidex) package insert[1]
- Anastrozole (Arimidex) patient drug information (Chemocare)[4]
- Anastrozole (Arimidex) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 1995-12-27: Initial approval for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. (Based on Buzdar et al. 1996 & Jonat et al. 1996)
- 2002-09-05: Accelerated approval for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. (Based on ATAC)
- 2005-09-16: Converted to regular approval for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. (Based on ATAC)
- Uncertain date: Approved for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. (Based on Arimidex Study Group 2000 & TARGETBreast)
History of changes in EMA indication
The approval of this drug pre-dates the EMA.
- 1995-08-11: EURD
History of changes in Health Canada indication
- 2004-06-30: Initial notice of compliance with conditions
- 2008-12-02: Conditions were met
Also known as
- Brand names: Altraz, Anabrez, Anastraze, Anastrazol Rontag, Anastrol, Arimidex, Asiolex, Karomex, Leprofen, RUI SI YI, RUI Ting, Trozolet, Trozolite.