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