Letov 2.5 Special Precautions

Laboratory Tests: No dose-related effect of Letrozole Tablets on any hematologic or clinical chemistry parameter was evident. Moderate decreases in lymphocyte counts, of uncertain clinical significance, were observed in some patients receiving letrozole tablets 2.5 mg. This depression was transient in about half of those affected. Two patients on Letrozole tablets developed thrombocytopenia; relationship to the study drug was unclear. Patient withdrawal due to laboratory abnormalities, whether related to study treatment or not, was infrequent. Increase in Serum glutamic-oxaloacetic transaminase (SGOT), Serum glutamic pyruvic transaminase (SGPT), and gamma Glutamyl transpeptidase (GT) ≥5 times the upper limit of normal (ULN) and of bilirubin ≥1.5 times the ULN were most often associated with metastic disease in the liver. About 3% of study participants receiving Letrozole Tablets had abnormalities in liver chemistries not associated with documented metastases; these abnormalities may have been related to study drug therapy.
Use in Children: The safety and effectiveness in pediatric patients have not been established.