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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Bone Health

Bone Health

For postmenopausal women, especially those taking aromatase inhibitors for hormone receptor-positive early breast cancer, taking extra care of the health of your bones is extremely important. In general, postmenopausal women are at increased risk for bone fractures as a result of decreased estrogen in the body, a hormone important for bone health. For postmenopausal women, taking an aromatase inhibitor like Femara® (letrozole) 2.5 mg tablets may increase this risk. This is because aromatase inhibitors further reduce the amount of estrogen in the body, which contributes to the loss of bone density. Left untreated, this process can result in osteoporosis, with increased risk for fractures and broken bones.

The following may help you protect the health and strength of your bones:

  • A well-balanced diet containing sufficient calcium and vitamin D.
  • Vitamin and mineral supplements: For adults ages 50 and over, the National Osteoporosis Foundation recommends 1,200 to 1,500 mg of calcium with 800 to 1,000 IU of vitamin D daily (to help your body absorb the calcium).
  • Engaging in 30 minutes of weight-bearing exercise three or more days a week may be optimal. See your doctor before starting or altering your exercise program.
  • Stop smoking and limit your alcohol intake. Drug treatment options are available to help you stop smoking. Ask your doctor about the right therapy for you.

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.