For US residents only
FEMARA is a form of hormone therapy known as an aromatase inhibitor, which works by reducing the amount of estrogen produced in the bodies of postmenopausal women.
FEMARA has been approved for:
FEMARA has been available for nearly 20 years and research by Novartis Oncology has continued during this time.
FEMARA is indicated for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
FEMARA is indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of FEMARA in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with FEMARA for a median of 60 months.
FEMARA 2.5 mg tablets is indicated for first-line treatment of postmenopausal women with hormone receptor-positive or unknown, locally advanced, or metastatic breast cancer. FEMARA is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Important Safety Information
FEMARA is only approved for use in postmenopausal women. You should not take FEMARA if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant (for example, if you are not sure of your postmenopausal status or recently became postmenopausal, or if you are perimenopausal). You should not take FEMARA if you are pregnant, as it may cause harm to an unborn child. You should also discuss with your doctor what to do if you are nursing a child. You and your doctor should decide whether to discontinue nursing or to discontinue the drug.
The use of FEMARA may cause decreases in the density of your bones, increases in bone fractures, and osteoporosis. Monitoring of the density of your bones may be required.
Some patients taking FEMARA had an increase in cholesterol. Your doctor may require the monitoring of cholesterol in your blood.
Some women reported fatigue, dizziness, and drowsiness with FEMARA. Until you know how it affects you, use caution before driving or operating machinery.
Some women had moderate decreases in white blood cell counts. The medical significance of this is not known. Decrease in platelet count has been reported.
Your doctor may tell you to take FEMARA every other day if you have severe liver disease. Always take your medicine exactly as prescribed by your doctor.
The most serious side effects seen with FEMARA are bone effects (fractures, decreased bone density, and osteoporosis) and increases in cholesterol. Other common side effects seen with FEMARA (≥20% of patients in clinical trials) include hot flashes, joint pain, flushing, weakness, swelling, headache, dizziness, increased sweating, bone pain, and muscle pain.
These are not all the possible side effects of FEMARA. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For full Prescribing Information, please click here.