INDICATIONS

ARIMIDEX is indicated for the treatment of advanced breast cancer in post-menopausal women with disease progression following tamoxifen therapy.

Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.

DOSAGE AND ADMINISTRATION

The dose of ARIMIDEX is one 1-mg tablet taken once a day.

Patients treated with ARIMIDEX do not require glucocorticoid or mineralocorticoid replacement therapy.

Patients with Hepatic Impairment: (See CLINICAL PHARMACOLOGY) Hepatic metabolism accounts for approximately 85% of anastrozole elimination. Although clearance of anastrozole was decreased in patients with cirrhosis due to alcohol abuse, plasma anastrozole concentrations stayed in the usual range seen in patients without liver disease. Therefore, no changes in dose are recommended for patients with mild-to-moderate hepatic impairment, although patients should be monitored for side effects. ARIMIDEX has not been studied in patients with severe hepatic impairment.

Patients with Renal Impairment: No changes in dose are necessary for patients with renal impairment.

HOW SUPPLIED

White, biconvex, film-coated tablets containing 1 mg of anastrozole. The tablets are impressed on one side with a logo consisting of a letter "A" (upper case) with an arrowhead attached to the foot of the extended right leg of the "A" and on the reverse with the tablet strength marking "Adx 1." These tablets are supplied in bottles of 30 tablets (NDC 0310-0201-30).

Store at controlled room temperature, 20°-25°C (68°-77°F) [see USP].