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Medi-10

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Uses

1.1 Adjuvant Treatment of Early Breast Cancer

Letrozole Tablets, USP are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. 

1.2 Extended Adjuvant Treatment of Early Breast Cancer

Letrozole Tablets, USP are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole for a median of 60 months [see Clinical Studies (14.2, 14.3)].

1.3 First and Second-Line Treatment of Advanced Breast Cancer

Letrozole Tablets, USP are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole Tablets, USP are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see Clinical Studies (14.4, 14.5)].

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Other Information

Letrozole Tablets, USP for oral administration contain 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4′-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile, and its structural formula is

structura-formula

Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31, empirical formula C17H11N5, and a melting range of 184°C to 185°C.

Letrozole is available as 2.5 mg tablets for oral administration.

Inactive Ingredients: Ferric Oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate and titanium dioxide.

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    Medi-10 | Apotex Corp.
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    Medi-10 | Apotex Corp.

    Medi-10 | Apotex Corp.
    2.1 Recommended Dose

    The recommended dose of letrozole tablet is one 2.5 mg tablet administered once a day, without regard to meals.

    2.2 Use in Adjuvant Treatment of Early Breast Cancer

    In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study was 5 years with 73% of the patients having completed adjuvant therapy. Treatment should be discontinued at relapse [see Clinical Studies (14.1)].

    2.3 Use in Extended Adjuvant Treatment of Early Breast Cancer

    In the extended adjuvant setting, the optimal treatment duration with letrozole tablets is not known. The planned duration of treatment in the study was 5 years. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration was 60 months. Seventy-one percent of patients were treated for at least 3 years and 58% of patients completed least 4.5 years of extended adjuvant treatment. The treatment should be discontinued at tumor relapse [see Clinical Studies (14.2)]. 

    2.4 Use in First and Second-Line Treatment of Advanced Breast Cancer

    In patients with advanced disease, treatment with letrozole tablets should continue until tumor progression is evident [see Clinical Studies (14.4, 14.5)].

    2.5 Use in Hepatic Impairment

    No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although letrozole blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablets in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see Warnings and Precautions (5.3)]. The recommended dose of letrozole tablets for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on letrozole exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined.

    2.6 Use in Renal Impairment

    No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥10 mL/min [see Clinical Pharmacology (12.3)].

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