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Arimidex (Anastrozole) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Adjuvant Treatment

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

First-Line Treatment

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.

Second-Line Treatment

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

Recommended Dose

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. ARIMIDEX can be taken with or without food.

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 [see Clinical Studies ].

No dosage adjustment is necessary for patients with renal impairment or for elderly patients [see Use in Specific Populations ].

Patients with Hepatic Impairment

No changes in dose are recommended for patients with mild-to-moderate hepatic impairment. ARIMIDEX has not been studied in patients with severe hepatic impairment [see Use in Specific Populations ].

DOSAGE FORMS AND STRENGTHS

The tablets are white, biconvex, film-coated 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”.

HOW SUPPLIED/STORAGE AND HANDLING

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].

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