Femara (letrozole tablets)

IMPORTANT SAFETY INFORMATION

Femara is only indicated 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, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. Learn more about Important Safety Information for Femara.

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Femara vs. Tamoxifen
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Femara Vs. Tamoxifen

Femara vs. Tamoxifen

Breast International Group (BIG) 1-98: The Femara
Adjuvant Therapy Trial

Background

For nearly 30 years, tamoxifen had been the gold standard in the treatment of breast cancer for postmenopausal women. In 1998, the International Breast Cancer Study Group (IBCSG) began a worldwide clinical trial known as BIG 1-98. The study involved more than 8,000 postmenopausal women. Among other things, it was designed to compare the effects of Femara® (letrozole) 2.5 mg tablets vs tamoxifen in postmenopausal women with hormone receptor-positive early stage breast cancer. Results from the study showed that at 73 months of follow up, Femara was more effective than tamoxifen at reducing the risk of breast cancer returning in postmenopausal women with hormone receptor-positive early stage breast cancer. Half of the women received tamoxifen while the other half received Femara.

Results Summary

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 the results of this large, international study of 60 months of treatment and 73 months of follow-up, Femara was approved for the adjuvant therapy of postmenopausal women with hormone receptor-positive early stage breast cancer. Further follow-up will be needed to determine long-term results, including safety and efficacy. Now women have an effective option to consider when discussing adjuvant treatment with their oncologists.

In postmenopausal women with hormone receptor-positive early breast cancer in the adjuvant setting:
Femara vs. Tamoxifen in the Adjuvant Setting

Click here for important safety information for Femara.

Remember to take your medicine as prescribed by your doctor.



Learn More About:

Learn more about Femara patient programs Learn more about Femara patient programs

*The Femara Cares Program™ Prescription Discount Card allows you to pay only $10 for your Femara prescriptions, if you are eligible. Novartis Pharmaceuticals Corporation will pay the rest, up to a maximum of $800 of your out-of-pocket costs in any 12-month period, toward your Femara prescriptions. This card is subject to change or termination at any time.

Not all patients will receive a total of $800 per year off their prescriptions. Total value of card determined by applicable patient co-pay or out-of-pocket cost.

The Femara Cares Program™ Prescription Discount Card is not valid for prescriptions for which payment may be made in whole or in part under federal or state healthcare programs, including but not limited to, Medicare or Medicaid, or for residents in MA. Limitations apply.

Indication
Femara® (letrozole) 2.5 mg tablets are approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone receptor-positive early stage breast cancer.

Important Safety Information

Femara is only indicated 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, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. 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.

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, temporary decreases in white blood cell counts. The medical significance of this is not known.

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 include joint pain, nausea, weight decrease, vaginal irritiation, and pain in the extremitites. Other important less commonly reported side effects include blood clots, other cancers, stroke, heart attack and endometrial cancer.

Femara is a once-daily, convenient prescription tablet. 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.

For full prescribing information, please click here.

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.