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AROMASIN®Highlights (exemestane)

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

AROMASIN® (exemestane) tablets, for oral use
Initial U.S. Approval: 1999

INDICATIONS AND USAGE

AROMASIN 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 AROMASIN 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 (AROMASIN 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 AROMASIN and tamoxifen (6.3% vs. 5.1%). Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were AROMASIN 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: AROMASIN 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 AROMASIN and megestrol acetate, respectively (6, 6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc 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 AROMASIN 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: 5/2018

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch