Letrozole

Preview FDA label, Breckenridge Pharmaceutical, Inc., oral, effective 2026-08-17. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Use in Renal Impairment No dosage adjustment is required for patients with renal impairment if creatinine clearance is greater than or equal to 10 mL/min [see Clinical Pharmacology ] .

Dosing in liver impairment

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 ].

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.