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Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Oncology | Pharmacology/Toxicology

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Kytril (granisetron) tablets

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: SmithKline Beecham
Approval Status: Approved November 1997
Treatment Area: nausea and vomiting associated with chemotherapy

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.

Side Effects

Kytril tablets are well tolerated. The most frequently reported adverse events are headache, asthenia and constipation.