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ONCOGENIC/CARCINOGENIC POTENTIAL

Animal species used

No. of animals

Routes of admn.

Dosage used

Duration

Rats

Not available

Oral

10, 30, and 100 mg/ kg/day

24 months

Results :

2 rare tumors were found in muscle in high-dose females: in 1, there was a rhabdomyosarcoma and, in another, there was a fibrosarcoma. This dose represents a plasma AUC(0-24) value of approximately 16 times the mean human plasma drug exposure after an 80 mg oral dose.(27)

Animal species used

No. of animals

Routes of admn.

Dosage used

Duration

Rats

Not available

Oral

100, 200, or 400 mg/ kg/day

24 months

Results :

A significant increase in liver adenomas in high-dose males and liver carcinomas in high-dose females was found. These findings occurred at plasma  AUC(0-24) values of approximately 6 times the mean human plasma drug exposure after an 80 mg oral dose.(27)