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Arimidex (Anastrozole) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.

ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal 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. For patients with advanced breast cancer, ARIMIDEX should be continued until tumor progression.

For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown. In the ATAC trial ARIMIDEX was administered for five years.

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.

Use in the Elderly

No dosage adjustment is necessary.

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).

Storage

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

AstraZeneca Pharmaceuticals LP

Wilmington, Delaware 19850

Made in USA

All trademarks are the property of the AstraZeneca group

© AstraZeneca 2004, 2007

Rev 05–07 SIC No. 30261–02

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