NUTLEY, New Jersey—Roche’s selective 5-HT3 receptor antagonist Kytril Injection (granisetron) has received FDA approval for both the prevention and treatment of postoperative nausea and vomiting. The FDA first approved Kytril Injection in December 1993 for chemotherapy-induced nausea and vomiting. Kytril oral tablets were approved in July 1999 for use in radiotherapy-induced nausea and vomiting.
When used for prevention, Kytril is given just before or during surgery. In the case of treatment, Kytril is given to a patient who experiences nausea and vomiting after surgery is completed. The approval was based on several randomized, double-blind, clinical trials showing that Kytril, at a variety of doses, is more effective than placebo in both the prevention and treatment of postoperative nausea and vomiting.
"There is a need for alternative therapies for postoperative nausea and vomiting," said T. J. Gan, MD, associate professor and director of clinical research, Department of Anesthesiology, Duke University Medical Center. Dr. Gan noted that patients who fail treatment with other antiemetics may be subjected to extended periods of nausea and vomiting and that these patients may be successfully managed with Kytril.
