Exemestane is an aromatase inhibitor indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Exemestane for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
EXEMESTANE is an aromatase inhibitor indicated 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 EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy. • treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.
Source: US FDA prescribing information
Breast cancer cell growth may be estrogen-dependent. Aromatase is the principal enzyme that converts androgens to estrogens both in pre- and postmenopausal women. While the main source of estrogen (primarily estradiol) is the ovary in premenopausal women, the principal source of circulating estrogens in postmenopausal women is from conversion of adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) by the aromatase enzyme in peripheral tissues. Exemestane is an irreversible, steroidal aromatase inactivator, structurally related to the natural substrate androstenedione. It acts as a false substrate for the aromatase enzyme, and is processed to an intermediate that binds irreversibly to the active site of the enzyme, causing its inactivation, an effect also known as "suicide inhibition".
Source: US FDA prescribing information
Recommended Dose: One 25 mg tablet once daily after a meal. Recommended Dose The recommended dose of EXEMESTANE in early and advanced breast cancer is one 25 mg tablet once daily after a meal. • 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 EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy. • the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.
Source: US FDA prescribing information
EXEMESTANE is contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. Patients with a known hypersensitivity to the drug or to any of the excipients.
Source: US FDA prescribing information
• Reductions in bone mineral density (BMD) over time are seen with exemestane use. • Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed. • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Reductions in Bone Mineral Density (BMD) • Early breast cancer: Adverse reactions occurring in ≥10% of patients in any treatment group (EXEMESTANE vs. tamoxifen) were hot flushes (21% vs. 20%), fatigue (16% vs. 15%), arthralgia (15% vs. 9%), headache (13% vs. 11%), insomnia (12% vs. 9%), and increased sweating (12% vs. 10%). Discontinuation rates due to AEs were similar between EXEMESTANE and tamoxifen (6% vs. 5%). Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were EXEMESTANE 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: EXEMESTANE 0.4%, tamoxifen 0.3%.
Source: US FDA prescribing information
Strong CYP 3A4 inducers: Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure. Increase the EXEMESTANE dose to 50 mg. Drugs That Induce CYP 3A4 Co-medications that induce CYP 3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort) may significantly decrease exposure to EXEMESTANE. Dose modification is recommended for patients who are also receiving a strong CYP 3A4 inducer.
Source: US FDA prescribing information
Store at 25°C (77ºF), excursions permitted to 15°–30°C (59°–86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Exemestane, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Exemestane 25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Aromasin 25 mg tabletOral | Pharmacia & Upjohn | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 21 October 1999 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Exemestane in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Exemestane and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Exemestane, including Aromasin.
Yes. The US FDA first approved Exemestane on 21 October 1999, according to Drugs@FDA.
No listed presentation of Exemestane is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Exemestane is classified under ATC code L02BG06 (Exemestane).
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