To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Kytril Approved For The Prevention Of Radiation-Induced Nausea And Vomiting URL: http://www.pslgroup.com/dg/11B6AA.htm Doctor's Guide July 29, 1999
PHILADELPHIA, PA -- July 29, 1999 -- The United States Food and Drug Administration has approved SmithKline Beecham's Kytril(R) (granisetron hydrochloride) Tablets, a 5-HT(3) receptor antagonist, for the prevention of nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. Kytril Tablets (2 mg, once daily) are currently indicated for the prevention of nausea and vomiting associated with emetogenic cancer therapies including high dose cisplatin. Radiation is the primary treatment for many kinds of cancer. Nausea and vomiting are two common side effects of radiation. Kytril Tablets are now approved as a safe and effective option for patients who undergo chemotherapy or radiation therapy. "Before the availability of 5-HT(3) receptor antagonists, virtually all patients undergoing total body irradiation and many who received upper abdominal radiation experienced nausea and vomiting," said Dr. Thomas Spitzer, director, Bone Marrow Transplant Program, Massachusetts General Hospital, Boston. "Now, Kytril offers doctors a safe, effective and convenient alternative to use against the nausea and vomiting associated with radiation." The decision to approve Kytril Tablets for this indication was based on the review of data from two U.S. clinical trials. The first trial was a double-blind, randomised study in which 18 patients undergoing total body irradiation (TBI) for bone marrow transplantation received Kytril Tablets. TBI consisted of 11 fractions of radiation over four days. Patients were given Kytril Tablets (2 mg) one hour prior to the first daily fraction of radiation. Over the entire four-day dosing period, 22 percent of patients treated with Kytril Tablets did not experience vomiting or receive rescue antiemetics, compared to zero percent of patients in a historical negative control group. In addition, patients who received Kytril Tablets also experienced significantly fewer emetic episodes during the first day of radiation and over the four-day treatment period compared to patients in the historical negative control group. The median time to the first emetic episode was 36 hours for patients who received Kytril Tablets. The most frequently reported adverse events were headache (28 percent), diarrhea (22 percent) and asthenia (11 percent). The second trial was a double-blind, randomised study of patients receiving fractionated upper abdominal radiation for cancer. Kytril Tablets (2 mg) were given one hour prior to radiation, composed of up to 20 daily fractions. Patients treated with Kytril Tablets had a significantly longer time to the first episode of vomiting (35 versus nine days) relative to those patients who received placebo, and a significantly longer time to first episode of nausea (11 versus one day). Kytril provided significantly greater protection from nausea and vomiting than placebo. The most frequently reported adverse events among patients treated with Kytril were diarrhea (27.6 percent), asthenia (25.4 percent) and constipation (19.4 percent). In these two studies, the adverse events reported by patients receiving Kytril Tablets and concurrent radiation were similar to those reported by patients receiving Kytril prior to chemotherapy. Overall, however, headache was less prevalent among RINV patients. With the administration of cytotoxic drugs or radiation to the abdomen (including total body irradiation), serotonin (5-HT) is released from enterochromaffin cells in the lining of the gastrointestinal tract. These cells are in close proximity to vagal neurons, which have 5-HT(3) receptors that bind to serotonin. With the release of serotonin and subsequent binding to the 5-HT(3) receptors, these vagal neurons are stimulated to transmit signals to the vomiting centre in the brain, resulting in nausea and vomiting. Granisetron, the active ingredient in Kytril Tablets, binds to the 5-HT(3) receptors located on the vagal neurons in the lining of the gastrointestinal tract, blocking the signal to the vomiting centre in the brain, thus preventing nausea and vomiting. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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