Carcinogenicity studies in mice and rats have been completed. No carcinogenic effects were observed in female mice with exposures 9-fold that of female humans at the recommended therapeutic dose. No carcinogenic effects were observed in rats at exposures up to 0.7-fold that of humans at the recommended therapeutic dose. No ritonavir-related teratogenicity has been observed in rats or rabbits. In addition, a slight increase in cryptorchidism was also noted in rats at exposures equivalent to 22 percent of the human therapeutic dose.
Preliminary data indicate minimal, if any, placental passage of ritonavir.
No effect of saquinavir has been seen on reproductive performance, fertility, or embryo survival in rats. No evidence for embryotoxicity or teratogenicity of saquinavir has been found in animal studies. Placental and breast milk transfer in animal studies Placental transfer of saquinavir in the rat and rabbit was minimal. 100 mg both administered bid. No effect has been seen on reproductive performance, fertility, or embryo survival in rats at exposures about twice those of human therapeutic exposure.