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Femara (letrozole)

THERAPEUTIC CLASS

Nonsteroidal aromatase inhibitor

DEA CLASS

RX

INDICATIONS

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.

ADULT DOSAGE

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

DOSING CONSIDERATIONS

Hepatic Impairment
Cirrhosis/Severe Hepatic Dysfunction: 2.5mg qod

ADMINISTRATION

Oral route

Take w/o regard to meals

HOW SUPPLIED

Tab: 2.5mg

CONTRAINDICATIONS

Women who are or may become pregnant.

WARNINGS/PRECAUTIONS

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.

ADVERSE REACTIONS

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

DRUG INTERACTIONS

Reduced plasma levels with coadministered tamoxifen.

PREGNANCY AND LACTATION

Category X, not for use in nursing.

MECHANISM OF ACTION

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.

PHARMACOKINETICS

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.

ASSESSMENT

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

MONITORING

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

PATIENT COUNSELING

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.

STORAGE

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

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