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AROMASIN® (exemestane)

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AROMASIN® Quick Finder

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Download Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

1.1 Adjuvant Treatment of Postmenopausal Women

AROMASIN 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 AROMASIN 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

AROMASIN Tablets are round, biconvex, and off-white to slightly gray. Each tablet contains 25 mg of exemestane. The tablets are printed on one side with the number "7663" in black.

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4 CONTRAINDICATIONS

AROMASIN 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. Table 1...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

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7 DRUG INTERACTIONS

Drugs That Induce CYP 3A4

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

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings in...

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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

AROMASIN® 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

AROMASIN Tablets are round, biconvex, and off-white to slightly gray. Each tablet contains 25 mg of exemestane. The tablets are printed on one side with the number "7663" in black.

...

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17 PATIENT COUNSELING INFORMATION

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

Bone Effects...

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Resources

AROMASIN Savings Card
For questions regarding the AROMASIN Savings Card, please call (800) 491-4554
website
Aromasin Website for Consumers and Patients
 
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Call (800) 438-1985

Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985

Report Adverse Event
Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.