Granisetron (Kytril) clinical safety and tolerance

Dilly, S.

Seminars in Oncology 21(3 Suppl 5): 10-14

1994


ISSN/ISBN: 0093-7754
PMID: 8042031
Document Number: 6860
Granisetron was safe and well tolerated by the majority of over 3,000 patients treated in clinical trials, including elderly and hepatically impaired patients. Careful examination of patient safety and tolerance data shows that granisetron doses ranging from 2 to 160 µg/kg are equivalent and associated with only two relatively minor side effects: headache and constipation. Granisetron has shown no clinically significant effects on the cardiovascular or central nervous system, including extrapyramidal effects. Laboratory test results did not change as a result of granisetron therapy. The favorable tolerability profile of granisetron probably reflects its high potency and selectivity for the human 5-HT3 receptor. The ease of administration and favorable safety profile of granisetron make it a very suitable drug for use as prophylaxis against chemotherapy-induced nausea and vomiting.

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Granisetron (Kytril) clinical safety and tolerance