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EXEMESTANE Tablet (GREENSTONE LLC)

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EXEMESTANE Tablet (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 Adjuvant Treatment of Postmenopausal Women

EXEMESTANE is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor...

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

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

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3 DOSAGE FORMS AND STRENGTHS

EXEMESTANE tablets are round, biconvex, off-white to slightly greyish sugar-coated tablets, about 6 mm diameter, printed with numbers 2858 on one side in black ink. Each tablet contains 25 mg of...

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4 CONTRAINDICATIONS

EXEMESTANE is contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients.

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5 WARNINGS AND PRECAUTIONS

5.1 Reductions in Bone Mineral Density (BMD)

Reductions in bone mineral density (BMD) over time are seen with exemestane use....

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6 ADVERSE REACTIONS

In the adjuvant treatment of early breast cancer, the most common adverse reactions occurring in ≥10% of patients in any treatment group (EXEMESTANE vs. tamoxifen) were mild to moderate hot flushes (21.2...

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7 DRUG INTERACTIONS

Drugs That Induce CYP 3A4

Co-medications that induce CYP 3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, or...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings in animal studies and its mechanism...

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10 OVERDOSAGE

Clinical trials have been conducted with exemestane given as a single dose to healthy female volunteers at doses as high as 800 mg and daily for 12 weeks to postmenopausal women with advanced breast cancer at...

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11 DESCRIPTION

EXEMESTANE tablets for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Breast cancer cell growth may be estrogen-dependent. Aromatase is the principal enzyme that converts androgens to...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

A 2-year carcinogenicity study in mice at doses of 50, 150, and 450 mg/kg/day...

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14 CLINICAL STUDIES

14.1 Adjuvant Treatment in Early Breast Cancer

The Intergroup Exemestane Study 031 (IES) was a randomized, double-blind, multicenter,...

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16 HOW SUPPLIED/STORAGE AND HANDLING

EXEMESTANE tablets are round, biconvex, off-white to slightly greyish sugar-coated tablets, about 6 mm diameter, printed with numbers 2858 on one side in black ink. Each tablet contains...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

...

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Patient Information
EXEMESTANE (exemestane) tablets
This Patient Information has been approved by the U.S. Food and Drug AdministrationRevised: 6/2018
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