HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use FEMARA safely and effectively. See full prescribing information for FEMARA.
Femara (letrozole) tablets
Initial U.S. Approval: 1997
INDICATIONS AND USAGE
Femara is an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (1.1)
Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy (1.2)
First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer (1.3)
DOSAGE AND ADMINISTRATION
Femara tablets are taken orally without regard to meals (2):
Recommended dose: 2.5.mg once daily (2.1)
Patients with cirrhosis or severe hepatic impairment: 2.5 mg every other day (2.5, 5.3)
DOSAGE FORMS AND STRENGTHS
2.5 milligram tablets (3)
CONTRAINDICATIONS
Women of premenopausal endocrine status, including pregnant women (4)
WARNINGS AND PRECAUTIONS
Decreases in bone mineral density may occur. Consider bone mineral density monitoring (5.1)
Increases in total cholesterol may occur. Consider cholesterol monitoring. (5.2)

Fatigue, dizziness and somnolence may occur. Exercise caution when operating machinery (5.4)
ADVERSE REACTIONS
The most common adverse reactions (>20%) were hot flashes, arthralgia (6.1); flushing, asthenia, edema, arthralgia, headache, dizziness, hypercholesterolemia, sweating increased, bone pain (6.2, 6.3); and musculoskeletal (6.4).
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 1/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1     INDICATIONS AND USAGE
1.1     Adjuvant Treatment of Early Breast Cancer 1.2     Extended Adjuvant Treatment of Early Breast Cancer 1.3     First and Second-Line Treatment of Advanced Breast Cancer 2     DOSAGE AND ADMINISTRATION
2.1     Recommended Dose 2.2     Use in Adjuvant Treatment of Early Breast Cancer 2.3     Use in Extended Adjuvant Treatment of Early Breast Cancer 2.4     Use in First and Second-Line Treatment of Advanced Breast Cancer 2.5     Use in Hepatic Impairment 2.6     Use in Renal Impairment 3     DOSAGE FORMS AND STRENGTHS
4     CONTRAINDICATIONS
5     WARNINGS AND PRECAUTIONS
5.1     Bone Effects 5.2     Cholesterol 5.3     Hepatic Impairment 5.4     Fatigue and Dizziness 5.5     Laboratory Test Abnormalities 6     ADVERSE REACTIONS
6.1     Adjuvant Treatment of Early Breast Cancer 6.2     Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 24 Months 6.3     Updated Analysis, Extended Adjuvant Treatment of Early Br