Important Safety Information

AROMASIN should not be used in women who are premenopausal, are nursing or pregnant, have a known hypersensitivity to the drug, or are taking estrogen-containing agents.

Dose modification is recommended for patients who are receiving certain medications, including strong CYP 3A4 inducers such as rifampicin and phenytoin.

In patients with early breast cancer, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving AROMASIN than either tamoxifen or placebo.

Reductions in bone mineral density over time are seen with use of AROMASIN.

In IES, incidence of adverse events (AEs; %) occurring in = 10% of patients in any treatment group (AROMASIN vs tamoxifen) were hot flashes (21.2 vs 19.9), fatigue (16.1 vs 14.7), arthralgia (14.6 vs 8.6), headache (13.1 vs 10.8), insomnia (12.4 vs 8.9), and increased sweating (11.8 vs 10.4). Discontinuation rates due to AEs were similar between AROMASIN and tamoxifen (6.3% vs 5.1%).

In advanced breast cancer, only 3% of patients on AROMASIN discontinued treatment due to adverse events. Most common adverse events were mild to moderate and included hot flushes (13% vs 5%), nausea (9% vs 5%), fatigue (8% vs 10%), increased sweating (4% vs 8%) and increased appetite (3% vs 6%) for AROMASIN and megestrol acetate, respectively.

Please see full prescribing information.

AROMASIN^® (exemestane tablets)

Back to Top