Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Información selecta para pacientes y cuidadores que se encuentra disponible en Español.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

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.

EXEMESTANE Tablet (GREENSTONE LLC) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use EXEMESTANE safely and effectively. See full prescribing information for EXEMESTANE.

EXEMESTANE tablets, for oral use
Initial U.S. Approval: 1999

INDICATIONS AND USAGE

EXEMESTANE is an aromatase inhibitor indicated for:

  • adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy (14.1).
  • treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy (14.2).

DOSAGE AND ADMINISTRATION

Recommended Dose: One 25 mg tablet once daily after a meal (2.1).

DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg (3).

CONTRAINDICATIONS

Patients with a known hypersensitivity to the drug or to any of the excipients (4).

WARNINGS AND PRECAUTIONS

  • Reductions in bone mineral density (BMD) over time are seen with exemestane use (5.1).
  • Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed (5.2).
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception (5.6, 8.1, 8.3).

ADVERSE REACTIONS

  • Early breast cancer: Adverse reactions occurring in ≥10% of patients in any treatment group (EXEMESTANE vs. tamoxifen) were hot flushes (21.2% vs. 19.9%), fatigue (16.1% vs. 14.7%), arthralgia (14.6% vs. 8.6%), headache (13.1% vs. 10.8%), insomnia (12.4% vs. 8.9%), and increased sweating (11.8% vs. 10.4%). Discontinuation rates due to AEs were similar between EXEMESTANE and tamoxifen (6.3% vs. 5.1%). Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were EXEMESTANE 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: EXEMESTANE 0.4%, tamoxifen 0.3% (6, 6.1).
  • Advanced breast cancer: Most common adverse reactions were mild to moderate and included hot flushes (13% vs. 5%), nausea (9% vs. 5%), fatigue (8% vs. 10%), increased sweating (4% vs. 8%), and increased appetite (3% vs. 6%) for EXEMESTANE and megestrol acetate, respectively (6, 6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Strong CYP 3A4 inducers: Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure. Increase the EXEMESTANE dose to 50 mg (2.2, 7).

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed (8.2).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2018

Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event