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About Femara

A history of experience. A future of commitment.
Femara® (letrozole tablets) was approved for use in the United States in 1997 and has been helping postmenopausal women with hormone receptor-positive early breast cancer ever since. Throughout its history, Femara has demonstrated effectiveness in treating various stages of this condition from early to locally advanced to metastatic. In postmenopausal women with hormone receptor-positive early stage breast cancer, in the adjuvant setting, Femara has been shown to help reduce the risk of breast cancer returning versus tamoxifen. Based on 26 months of follow-up data, Femara significantly reduces the risk of distant metastasis when it is taken as initial adjuvant therapy after surgery. Femara also has been shown to reduce the risk of breast cancer returning when taken within three months of completion of five years of tamoxifen therapy. In addition, Femara reduced the risk of disease progression in patients with advanced breast cancer. Further follow-up will be needed to determine long-term results, including safety and efficacy. Femara has not been shown to improve survival versus tamoxifen. Time to distant metastasis and overall survival are secondary end points, and the primary end point of this study is DFS (disease-free survival). Approval in the adjuvant setting was based on a median of 26 months of follow-up.

Indication
Femara® (letrozole tablets) is approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone receptor-positive early stage breast cancer. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, safety and efficacy.

Femara is also approved for the extended adjuvant treatment of early stage breast cancer in postmenopausal women who are within three months of completion of five years of tamoxifen therapy. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, including side effects.

In addition, Femara is approved for the treatment of postmenopausal women with estrogen receptor-positive or estrogen receptor-unknown breast cancer that has spread to another part of the body (metastatic cancer). Femara is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Important Safety Information

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, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. Femara is only indicated in postmenopausal women. Talk to your doctor if you're allergic to Femara or any of its ingredients. You should not take Femara if you are pregnant as it may cause harm to an unborn child. Some women reported fatigue and dizziness with Femara. Until you know how it affects you, use caution before driving or operating machinery. Some patients taking Femara had an increase in cholesterol. Additional follow-up is needed to determine the risk of bone fracture associated with long-term use of Femara.

In the adjuvant setting, commonly reported side effects are generally mild to moderate. The most common side effects seen with Femara include hot flashes, joint pain, night sweats, weight gain, nausea, tiredness, other heart-related events, and bone fractures. Other less commonly reported side effects include vaginal bleeding, blood clots, other cancers, osteoporosis, stroke, heart attack, and endometrial cancer.

In the extended adjuvant setting, commonly reported side effects are generally mild to moderate. Commonly reported side effects for Femara include hot flashes, fatigue, joint pain, headache, increase in sweating, swelling due to fluid retention, increase in cholesterol, dizziness, constipation, nausea, heart-related problems, muscle pain, osteoporosis, arthritis, and bone fracture.

In the metastatic cancer setting, commonly reported side effects are generally mild to moderate and may include bone pain, hot flashes, back pain, nausea, joint pain, shortness of breath, tiredness, coughing, constipation, limb pain, chest pain, and headache.

Femara is a once-daily convenient prescription tablet.

For additional safety information, please see the prescribing information.

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.