Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui Medicine Co., Ltd. Drugs

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  Gabapentin

  

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  2.1 Recommended Dose

  The recommended dose of Letrozole Tablets, USP 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 are 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 at 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, USP 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 tablets 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 tablets 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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