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Femara (letrozole)


Nonsteroidal aromatase inhibitor




Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 yrs of adjuvant tamoxifen therapy. First-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.


Breast Cancer

Adjuvant Treatment of Postmenopausal Women w/ Hormone Receptor Positive Early Breast Cancer:
2.5mg qd; d/c at relapse

Extended Adjuvant Treatment of Early Breast Cancer in Postmenopausal Women, Who Have Received 5 Years of Adjuvant Tamoxifen Therapy:
2.5mg qd; d/c at tumor relapse

1st-Line Treatment of Postmenopausal Women w/ Hormone Receptor Positive or Unknown, Locally Advanced or Metastatic Breast Cancer; Treatment of Advanced Breast Cancer in Postmenopausal Women w/ Disease Progression Following Antiestrogen Therapy:
2.5mg qd; continue until tumor progression is evident


Hepatic Impairment
Cirrhosis/Severe Hepatic Dysfunction: 2.5mg qod


Oral route

Take w/o regard to meals


Tab: 2.5mg


Women who are or may become pregnant.


May decrease bone mineral density (BMD); consider monitoring BMD. Bone fractures and osteoporosis reported. Hypercholesterolemia reported; consider monitoring serum cholesterol levels. Reduce dose by 50% with cirrhosis and severe hepatic impairment. May impair physical/mental abilities. Moderate decreases in lymphocyte counts and thrombocytopenia reported.


Hypercholesterolemia, hot flushes, fatigue, edema, arthralgia/arthritis, myalgia, headache, dizziness, night sweats, nausea, back pain, bone fractures, weight increase, depression, osteopenia.


Reduced plasma levels with coadministered tamoxifen.


Category X, not for use in nursing.


Nonsteroidal aromatase inhibitor; inhibits the conversion of androgens to estrogens. Inhibits the aromatase enzyme by competitively binding to the heme of the CYP450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues.


Absorption: Rapid and complete. Distribution: Vd=1.9L/kg. Metabolism: Liver via CYP3A4, CYP2A6. Elimination: Urine (75%, glucuronide of carbinol metabolite; 9%, unidentified metabolites; 6%, unchanged); T1/2=2 days.


Assess for premenopausal endocrine status, cirrhosis or hepatic impairment, pregnancy/nursing status, and possible drug interactions.


Monitor for bone fractures, osteoporosis, fatigue, dizziness, somnolence, and other adverse reactions. Monitor BMD and serum cholesterol levels.


Inform that the drug is contraindicated in pregnant women and women of premenopausal endocrine status. Counsel perimenopausal and recently postmenopausal women to use contraception until postmenopausal status is fully established. Advise about possible fatigue, dizziness, and somnolence; caution against operating machinery/driving. Advise that BMD may be monitored while on therapy.


25°C (77°F); excursions permitted to 15-30°C (59-86°F).


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