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Bone Effects: Letrozole may cause decrease in bone mineral density (BMD).
Cholesterol: Consideration should be given to monitoring serum cholesterol.
Hepatic treatment: Subjects with cirrhosis and severe hepatic impairment who were dosed with 2.5 mg of Letrozole experienced approximately twice the exposure to Letrozole as healthy volunteers with normal liver function. Therefore, a dose reduction is recommended for this patient population.
Fatigue and Dizziness: Because fatigue, dizziness, and somnolence have been reported, caution is advised when driving or using machinery.
Use in Pregnancy: Letrozole may cause fetal harm when administered to pregnant women. Studies in rats at doses equal to or greater than 0.003 mg/kg (about 1/100 the daily maximum recommended human dose on a mg/m2 basis) administered during the period of organogenesis, have shown that letrozole is embryotoxic and fetotoxic, as indicated by intrauterine mortality, increased resorption, increased post implantation loss, decreased numbers of live fetuses and fetal anomalies including absence and shortening of renal papilla, dilation of ureter, edema and incomplete ossification of frontal skull and metatarsals. Letrozole was teratogenic in rats. A 0.03 mg/kg dose (about 1/10 the daily maximum recommended human dose on a mg/m2 basis) caused fetal domed head and cervical/centrum vertebral fusion.
Letrozole is embryotoxic at doses equal to or greater than 0.002 mg/kg and fetotoxic when administered to rabbits at 0.02 mg/kg (about 1/100,000 and 1/10,000 the daily maximum recommended human dose on a mg/m2 basis, respectively). Fetal anomalies included incomplete ossification of the skull, sternebrae, and fore and hind legs.
There are no studies in pregnant women. Letrozole is indicated for postmenopausal women.
If there is exposure to Letrozole during pregnancy, the patient should be appraised of the potential hazard to the fetus and potential risk for loss of the pregnancy.
