Advanced (Metastatic) Hormone Receptor-Positive or Hormone Receptor-Unknown Breast Cancer Therapy
Today there are an increasing number of options for treating advanced (metastatic) hormone receptor-positive or hormone receptor-unknown breast cancer. Traditional methods include surgery (procedures such as lumpectomy or mastectomy), radiation therapy (applied at the site of the cancer), and chemotherapy. Chemotherapy drugs kill cancer cells, but because they cannot differentiate between cancer cells and normal cells, they also kill some normal cells in the process.
Femara® (letrozole tablets) is not a chemotherapy drug. It is an aromatase inhibitor. Aromatase inhibitors are classified as hormone therapy.
Hormone therapy does not act directly on cancer cells. Instead, it affects hormones—enzymes our bodies produce naturally that play an important role in many body functions. Specifically, the female hormone estrogen plays an important role in breast cancer. Estrogen feeds cancer tumors and makes them grow and spread. Breast cancers that grow because of estrogen are called hormone dependent or estrogen dependent.
Hormone therapy in breast cancer acts on estrogen, either directly or indirectly. The goal of hormone therapy is to deprive cancer cells of the estrogen that allows them to grow.
In premenopausal women, the ovaries are the primary source of estrogen production. In postmenopausal women, the ovaries no longer produce estrogen. However, the body produces estrogen from other hormones known as androgens through the action of an enzyme called aromatase.
Aromatase is the enzyme that produces estrogen in the postmenopausal women. By interfering with the production of estrogen triggered by aromatase, Femara reduces the total amount of estrogen in the body.
Tamoxifen, introduced in the 1970s, was the first hormone therapy and a major breakthrough in the treatment of breast cancer. It's known as an antiestrogen therapy. It blocks the action of estrogen by attaching to estrogen receptors in cancer cells and preventing estrogen from binding to them.
Femara is approved for the treatment of postmenopausal women with hormone receptor-positive or hormone 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.
Talk with your doctor to find out if Femara may be right for you.
Remember to take your medicine as prescribed by your doctor.
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Indication 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 
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