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Approval with conditions of PrFEMARA* 2.5 mg tablets for adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
FEMARAFootnote * is a tablet that contains 2.5 mg of the active substance letrozole.
Health Canada has approved FEMARA with conditions, under the Notice of Compliance with Conditions policy for the use in the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. This authorization reflects the promising nature of the clinical evidence and safety of FEMARA, which must be verified and/or extended with further studies. Products approved under Health Canada's NOC/c policy, have demonstrated promising benefit, are high quality and possess an acceptable safety profile based on a benefit/risk assessment.
Adjuvant treatment of hormone receptor positive early breast cancer in postmenopausal women.
Early breast cancer is confined to the breast, and may or may not have spread to the lymph nodes in the breast or armpit area. Breast cancer that has metastasized (spread) to other parts of the body is considered to be advanced/metastatic breast cancer.
Adjuvant treatment of early breast cancer is used to help reduce the risk of recurrence (cancer coming back or spreading to other parts of the body) after surgery.
Estrogen is a normally occurring female sex hormone that stimulates normal breast tissue and the growth of some types of breast cancer. FEMARA belongs to a class of medications called aromatase inhibitors which act by binding to aromatase, a substance needed to make estrogen. As a result, the production of estrogen and the growth of certain types of breast cancer is reduced.
It has been shown that women taking FEMARA as an adjuvant therapy, reduce the risk of breast cancer recurrence by an additional 19% compared to tamoxifen. In addition, FEMARA reduced the spread of the cancer to other parts of the body (distant metastasis) by 27% as compared to the gold standard, tamoxifen. However, women treated with FEMARA who did not have cancer in the lymph nodes had not yet shown an efficacy benefit compared to those treated with tamoxifen.
Femara has not yet been compared to other Aromatase Inhibitors in a clinical study.
FEMARA is contraindicated in pre-menopausal women.
The use of some aromatase inhibitors, including FEMARA may increase the risk of cardiovascular events compared to tamoxifen, such as heart attack s and stroke. Women at risk of heart disease should be carefully monitored by their doctor.
The use of aromatase inhibitors, including FEMARA may increase lipid levels. Your doctor should continue routine checking of your lipid and cholesterol levels on a regular basis.
Long term use of FEMARA may result in a reduction in bone mineral density and may increase the risk of osteoporosis and fracture. Your doctor should continue his/her routine clinical practice of monitoring bone mineral density on a regul ar basis.
Talk to your doctor if you have a personal or family history of high cholesterol, heart disease or osteoporosis or a recent history of fractures.
Most side effects are mild to moderate and rarely severe enough to stop treatment with FEMARA. The most frequently reported adverse reactions were: hot flushes, pain in the muscles, bones and joints and joint stiffness (arthralgia or arthritis). Other common side effects which may occur are: mild headache, swelling or puffiness of the feet, ankles or other part of the body due to retained body fluid, weight increase, fatigue, nausea, vomiting, indigestion, increase or loss of appetite, constipation, diarrhea, hair loss, rash, dizziness, increased sweating, sad mood (depression), vaginal bleeding, vaginal irritation, breast pain, anorexia, blurry vision and cataracts.
Do not be alarmed by this list of possible side effects. You may not experience any of them. Check with your doctor if the unwanted side effects do not go away during treatment or are bothersome.
One 2.5 mg tablet once daily by mouth. The tablet should be swallowed with a small glass of water. You can take FEMARA with or without food. It is best to take FEMARA at about the same time every day. Your doctor will decide for how long you should be treated with FEMARA.
Patients who are hypersensitive to letrozole, or to any ingredient in the tablet formulation, should not take FEMARA.
If you have questions concerning FEMARA, kindly contact our Medical Information department at 1-800-363-8883.
Please consult your doctor with any questions or concerns you may have regarding your individual condition.
This document including the FEMARA Prescribing Information and Patient Information can be found on our Website (http://www.novartis.ca).
PrFEMARA* is a registered trademark