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AROMASIN®(exemestane)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
AROMASIN® Quick Finder
Highlights
Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
AROMASIN is contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients.
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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Reductions in Bone Mineral Density (BMD) [see Warnings and...
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Drug Interactions
7 DRUG INTERACTIONS
Drugs That Induce CYP 3A4
Co-medications that induce CYP 3A4 (e.g., rifampicin, phenytoin, carbamazepine,...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
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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Clinical Studies
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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How Supplied/Storage and Handling
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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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Bone Effects...
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
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.
(800)-332-1088.