Idelara

Idelara Dosage/Direction for Use

letrozole

Manufacturer:

Craveri

Distributor:

Apolloplus Capital

Marketer:

Bioprofarma Bago
Full Prescribing Info
Dosage/Direction for Use
Adult and elderly patients: The recommended dose of Letrozole (Idelara) is one 2.5 mg tablet administered once a day, without regard to meals. In patients with advanced disease, treatment with Letrozole (Idelara) should continue until tumor progression is evident.
In the extended adjuvant setting, the optimal treatment duration with letrozole is not known. The planned duration of treatment in the study was 5 years. However, at the time of the analysis, the median treatment duration was 24 months, 25% of patients were treated for at least 3 years and less than 1% of patients were treated for the planned duration of 5 years.
The median duration of follow-up was 28 months. Treatment should be discontinued at tumor relapse.
In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study is 5 years. However, at the time of analysis, the median duration of treatment was 24 months, median duration of follow up was 26 months, and 16% of the patients have been treated for 5 years. Treatment should be discontinued at relapse.
No dose adjustment is required for elderly patients. Patients treated with letrozole do not require glucocorticoid or mineralocorticoid replacement therapy.
Renal impairment: No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥10 ml/min.
Hepatic impairment: No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although letrozole blood concentrations were modestly increased. The dose of letrozole in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50%. The recommended dose of letrozole 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.
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