Femara (letrozole) : Early Breast Cancer Post Tamoxifen Treatment
Femara (letrozole) : Early Breast Cancer Post Tamoxifen Treatment


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Treatment Options

To help you better understand the stages of therapy and how FEMARA fits into the overall spectrum of options in the treatment of early stage breast cancer in postmenopausal women, the following diagram has been designed:

Femara (letrozole) : Breast Cancer Treatment Stages

Diagnosis

  • Early stage breast cancer is cancer localized to breast tissue and/or nearby lymph nodes
  • Diagnosis is verified via excision/biopsy of the tumor
  • In the US over 200,000 women are diagnosed with early stage breast cancer annually1

Surgery

  • Tumor(s) removed by lumpectomy or mastectomy
  • Includes removal and examination of axillary lymph nodes
  • In some cases, neo-adjuvant therapy may be administered to reduce tumor size before surgery

After surgery, the risk of cancer coming back is ongoing. Oncologists generally recommend additional treatment to help reduce that risk. There are many factors that may contribute to the chance of recurrence, including patients whose cancer had previously spread to the lymph nodes and whose tumor was large in size2. Other factors may include estrogen-receptor status, menopausal status and family history.

Adjuvant Therapy

  • Approximately one-third of women with estrogen receptor-positive breast cancer experience a recurrence3
  • Therapy used to reduce the risk of cancer coming back after initial treatment which may include chemotherapy, radiation and/or hormonal therapy
    • Radiation is most often given after lumpectomy to destroy cancer cells in a specific area
    • Chemotherapy is given to destroy cancer cells throughout the body
    • Hormonal therapy (which includes FEMARA) blocks the action of hormones as it applies to breast cancer

Extended Adjuvant Therapy

  • Approximately one-third of women with estrogen receptor-positive breast cancer experience a recurrence4
  • Over half of breast cancer recurrences occur more than five years after surgery
  • Therapy used to lower the risk of cancer returning after the completion of five years of tamoxifen
  • FEMARA is the first and only treatment approved for use after five years of tamoxifen
1 American Cancer Society. Cancer Facts and Figures 2006. http://www.cancer.org/downloads/STT/CAFF2006PWSecured.pdf. Accessed August 15th, 2007. Page 4, Table 1.
2Breast Health Resource Guide, 4th Edition. Avon Foundation.
3Saphner T, Tomey D, Gray R. Annual Hazard Rates of Recurrence for Breast Cancer After Primary Therapy. J of Clin Onc. 1996.
4Introduction and methods sections reproduced from: Early Breast Cancer Trialists' Collaborative Group "Treatment of Early Breast Cancer. Volume 1. Worldwide Evidence 1985-1990." http://www.ctsu.ox.ac.uk. Accessed in 2004.


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 trial 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 hormone receptor-positive or hormone receptor-unknown breast cancer that has spread to another part of the body (metastatic cancer).

Ask your oncologist if Femara is right for you.

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 fetal harm. 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, cardiovascular ischemic events, 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.











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