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HOME >> API >> API List1 >> Anastrozole >> Precautions

ANASTROZOLE (CAS NO.: 120511-73-1)
PRECAUTIONS
General

ANASTROZOLE is not recommended for use in premenopausal women as safety and efficacy has not been established (see CLINICAL PHARMACOLOGY, Pharmacodynamics, Effect on Estradiol section).

Before starting treatment with ANASTROZOLE, pregnancy must be excluded (see WARNINGS). ANASTROZOLE should be administered under the supervision of a qualified physician experienced in the use of anticancer agents.
Pregnancy
Pregnancy Category D

Nursing Mothers

It is not known if anastrozole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ANASTROZOLE is administered to a nursing woman (see WARNINGS and PRECAUTIONS).
Pediatric Use

The safety and efficacy of ANASTROZOLE in pediatric patients have not been established.
Geriatric Use

In studies 0030 and 0027 about 50% of patients were 65 or older. Patients ≥ 65 years of age had moderately better tumor response and time to tumor progression than patients < 65 years of age regardless of randomized treatment. In studies 0004 and 0005 50% of patients were 65 or older. Response rates and time to progression were similar for the over 65 and younger patients.

In the ATAC study, patients who were 65 years of age or older (N=1413 for ANASTROZOLE and N=1410 for tamoxifen), the hazard ratio for disease-free survival was 0.93 (95% CI: 0.80, 1.08) for ANASTROZOLE compared to tamoxifen.

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