AROMASIN is 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 AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy.

AROMASIN is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

The recommended dose of AROMASIN in early and advanced breast cancer is one 25 mg tablet once daily after a meal.

In postmenopausal women with early breast cancer who have been treated with 2-3 years of tamoxifen, treatment with AROMASIN should continue in the absence of recurrence or contralateral breast cancer until completion of five years of adjuvant endocrine therapy.

For patients with advanced breast cancer, treatment with AROMASIN should continue until tumor progression is evident.

For patients receiving AROMASIN with a potent CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of AROMASIN is 50 mg once daily after a meal.

The safety of chronic dosing in patients with moderate or severe hepatic or renal impairment has not been studied. Based on experience with exemestane at repeated doses up to 200 mg daily that demonstrated a moderate increase in non-life threatening adverse events, dosage adjustment does not appear to be necessary (see CLINICAL PHARMACOLOGY, Special Populations and PRECAUTIONS).

AROMASIN Tablets are round, biconvex, and off-white to slightly gray. Each tablet contains 25 mg of exemestane. The tablets are printed on one side with the number "7663" in black. AROMASIN is packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets.

30-tablet HDPE bottle....................NDC 0009-7663-04

Store at 25° C (77° F); excursions permitted to 15° -30° C (59° -86° F) [see USP Controlled Room Temperature].

Distributed by Pharmacia and Upjohn Company, Division Of Pfizer Inc, NY, NY 10017. Revised February 2007. FDA Rev date: 10/5/2005

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