Peripheral neuropathy has been reported in patients treated with Zavesca.

• Patients should undergo neurological examination at the start of treatment and every 6 months thereafter; Zavesca should be reassessed in patients who develop symptoms of peripheral neuropathy

Zavesca may cause fetal harm if administered to a pregnant woman.

• Pregnancy category X; Zavesca is contraindicated in women who are or who may become pregnant; patients should be apprised of the potential hazard to a fetus

There is a risk of impaired fertility in men.

• Men should maintain reliable contraceptive methods and not plan to conceive while taking Zavesca and for 3 months thereafter