ZOLETA™

Composition:

Each flim coated tablet contains letrozole USP 2.5 mg

General description:

ZOLETA™ is a potent and highly specific nonsteroidal aromatase inhibitor. It inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues. Letrozole exerts its antitumor effect by depriving estrogen dependent breast cancer cells of their growth stimulus. In postmenopausal women, estrogens are derived mainly from the action of the aromatase enzyme, which converts adrenal androgens, primarily androstenedione and testosterone to oestrone (El) and oestradiol (E2). The suppression of estrogen biosynthesis in the peripheral tissues and the malignant tissues can be achieved by specifically inhibiting the aromatase enzyme.

Indications:

The first line treatment of advanced/metastatic breast cancer (hormone receptor positive or receptor status unknown) in postmenopausal women.

Contraindication:

• Known or suspected hypersensitivity to letrozole, other aromatase inhibitor

• Pregnancy

• Lactating mother

• Severe hepatic dysfunction

Side effect:

Mild to moderate musculoskeletal pain, arthralgia, headache, fatigue, nausea, dyspnoea, peripheral oedema 

Prescribing Information:

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