ELET

This medication falls into FDA pregnancy category D and causes congenital malformations when administered during pregnancy. It should not be administered during pregnancy.

Letrozole is contraindicated during breast-feeding.

STORAGE AND HANDLING

Keep the medication stored at normal room temperature and out of reach of children and pets. Dispose unused medications and expired medications properly to avoid adverse effects.

INDICATIONS

Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Extended adjuvant treatment of early breast cancer; Postmenopausal women, who have received 5 yr of adjuvant tamoxifen therapy.
First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-estrogens.
Neoadjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.

CONTRAINDICATIONS

Known hypersensitivity to letrozole.
Patients with premenopausal endocrine status.
Patients with insulin dependent diabetes.
Patients with premenopausal, pregnant or lactating women.

DOSAGE AND METHOD OF ADMINISTRATION

Route of Administration: Oral

The dose must be as directed by the physician. Only women with post-menopausal endocrine status must receive Letrozole.

Children: Not applicable for this product.

SIDE EFFECTS

Letrozole is generally well tolerated. The most frequently reported side effects in clinical studies were hot flushes, hypercholesterolemia, arthralgia, fatigue, increased sweating and nausea. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Call your doctor right away if you have serious side effects like serious allergic reactions.