General Information

A single 2 mg dose of Kytril (granisetron hydrochloride) has been approved for the treatment of nausea and vomiting associated with chemotherapy. Until now, the recommended dosage for Kytril tablets was one 1 mg tablet administered anytime within one hour before chemotherapy and a second 1 mg tablet 12 hours after the first. Now cancer patients can take Kytril tablets either once or twice daily to prevent nausea and vomiting associated with chemotherapy. Kytril, which is a 5-HT (subscript 3) receptor antagonist, is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.

Clinical Results

This labeling change was based in part on results from a double-blind multicenter trial in which 697 patients were randomized to receive either a single 2 mg dose of Kytril tablets or one 1 mg Kytril tablet one hour prior to chemotherapy and another 1 mg tablet 12 hours after the first tablet was given. Investigators evaluated the percentage of patients who achieved a complete response (no vomiting, no moderate or severe nausea and no rescue medication) and the incidence of emesis and nausea. Patients receiving a single 2 mg dose of Kytril tablets achieved a 64 percent response rate versus 69 percent for patients receiving Kytril tablets twice daily. This difference was not statistically significant.