Letrostad Special Precautions

In patients whose postmenopausal status seems unclear, LH, FSH and/or estradiol levels must be assessed before initiating treatment in order to clearly establish menopausal status.
Letrozole has not been investigated in a sufficient number of patients with creatinine clearance < 30 mL/min.
Letrozole has only been investigated in a limited number of women with non-metastatic disease and different levels of liver disease: mild to moderate and severe hepatic impairment. In male volunteers with severe hepatic impairment (cirrhosis and Child-Pugh grade C) without tumour disease systemic exposure and terminal half-life were increased two- to threefold compared to healthy volunteers. Letrostad should therefore be used with caution and after careful risk-benefit assessment in such patients.
Letrostad leads to a marked decrease in oestrogen levels. The median duration of observation of 30 and 39 months for adjuvant and extended adjuvant setting, respectively, is insufficient to assess the risk of fractures associated with the long-term use of Letrostad.
Women with osteoporosis and/or fractures in their medical history or at increased risk of osteoporosis should have their bone mineral density assessed prior adjuvant or extended adjuvant treatment is commenced. These women should be monitored during and following treatment with Letrozole for the development of osteoporosis. If necessary, prophylaxis or treatment of osteoporosis should be initiated and regularly monitored.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: Since fatigue and dizziness have been observed with the use treatment for advanced breast cancer and as adjuvant treatment of primary breast cancer and somnolence has been reported uncommonly, caution is advised when driving or using machines.