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TRAVATAN (TRAVOPROST): NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg / kg per day did not show any evidence of carcinogenic potential. However, at 100 mcg / kg per day, male rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. The high dose (100 mcg / kg) corresponds to exposure levels over 400 times the human exposure at the maximum recommended human ocular dose (MRHOD) of 0.04 mcg / kg, based on plasma active drug levels.
Travoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay. A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in the presence of rat S-9 activation enzymes.
Travoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to 10 mcg / kg per day [250 times the maximum recommended human ocular dose of 0.04 mcg / kg per day on a mcg / kg basis (MRHOD)]. At 10 mcg / kg per day, the mean number of corpora lutea was reduced, and the post-implantation losses were increased. These effects were not observed at 3 mcg / kg per day (75 times the MRHOD).
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