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Renal impairment: Letrozole has not been investigated in patients with creatinine clearance <10 mL/min. The potential risk/benefit to such patients should be carefully considered before administration of letrozole.
Hepatic impairment: In patients with severe hepatic impairment (Child-Pugh score C), systemic exposure and terminal half-life were approximately doubled compared to healthy volunteers. Such patients should therefore be kept under close supervision.
Bone effects: Osteoporosis and/or bone fractures have been reported with the use of letrozole. Therefore, monitoring of overall bone health is recommended during treatment.
Effects on Ability to Drive and Use Machines: Since fatigue and dizziness have been observed with the use of letrozole and somnolence has been reported uncommonly, caution is advised when driving or using machines.
