Exemestane (Aromasin)

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.
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.

Diseases for which it is used

• Breast cancer

Patient drug information

• Exemestane (Aromasin) package insert
• Exemestane (Aromasin) patient drug information (Chemocare)
• Exemestane (Aromasin) patient drug information (UpToDate)

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