FDA label 72f9a785-344c-481c-9cdc-7a9dc0f59fb4

WARNINGS Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists.

ADVERSE REACTIONS Chemotherapy-Induced Nausea and Vomiting The following have been reported during controlled clinical trials or in the routine management of patients. The percentage figures are based on clinical trial experience only. Table 7 gives the comparative frequencies of the five most commonly reported adverse events (≥3%) in patients receiving granisetron hydrochloride injection, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24-hour period following granisetron hydrochloride injection administration. Events were generally recorded over seven days post-granisetron hydrochloride injection administration. In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to granisetron hydrochloride injection , except for headache, which was clearly more frequent than in comparison groups. Table 7. Principal Adverse Events in Clinical Trials — Single-Day Chemotherapy Percent of Patients With Event Granisetron Hydrochloride Injection 40 mcg/kg (n=1268) Comparator Metoclopramide/dexamethasone and phenothiazines/dexamethasone. (n=422) Headache 14% 6% Asthenia 5% 6% Somnolence 4% 15% Diarrhea 4% 6% Constipation 3% 3% In over 3,000 patients receiving granisetron hydrochloride injection (2 to 160 mcg/kg) in single-day and multiple-day clinical trials with emetogenic cancer therapies, adverse events, other than those in Table 7 , were observed; attribution of many of these events to granisetron hydrochloride injection is uncertain. Hepatic In comparative trials, mainly with cisplatin regimens, elevations of AST and ALT (>2 times the upper limit of normal) following administration of granisetron hydrochloride injection occurred in 2.8% and 3.3% of patients, respectively. These frequencies were not significantly different from those seen with comparators (AST: 2.1%; ALT: 2.4%). Cardiovascular Hypertension (2%); hypotension, arrhythmias such as sinus bradycardia, atrial fibrillation, varying degrees of A-V block, ventricular ectopy including non-sustained tachycardia, and ECG abnormalities have been observed rarely. Central Nervous System Agitation, anxiety, CNS stimulation and insomnia were seen in less than 2% of patients. Extrapyramidal syndrome occurred rarely and only in the presence of other drugs associated with this syndrome. Hypersensitivity Rare cases of hypersensitivity reactions, sometimes severe (eg, anaphylaxis, shortness of breath, hypotension, urticaria) have been reported. Other Fever (3%), taste disorder (2%), skin rashes (1%). In multiple-day comparative studies, fever occurred more frequently with granisetron hydrochloride injection (8.6%) than with comparative drugs (3.4%, P <0.014), which usually included dexamethasone.

<table width="80%" ID="table7"> <caption>Table 7. Principal Adverse Events in Clinical Trials &#x2014; Single-Day Chemotherapy</caption> <col width="20%" align="left" valign="middle"/> <col width="40%" align="center" valign="middle"/> <col width="40%" align="center" valign="middle"/> <thead> <tr styleCode="Botrule"> <th styleCode="Lrule Rrule"/> <th styleCode="Rrule" colspan="2">Percent of Patients With Event</th> </tr> <tr> <th styleCode="Lrule Rrule"/> <th styleCode="Rrule">Granisetron Hydrochloride Injection 40 mcg/kg (n=1268)</th> <th styleCode="Rrule">Comparator<footnote>Metoclopramide/dexamethasone and phenothiazines/dexamethasone.</footnote> (n=422)</th> </tr> </thead> <tbody> <tr> <td styleCode="Lrule Rrule">Headache</td> <td styleCode="Rrule">14%</td> <td styleCode="Rrule">6%</td> </tr> <tr> <td styleCode="Lrule Rrule">Asthenia</td> <td styleCode="Rrule">5%</td> <td styleCode="Rrule">6%</td> </tr> <tr> <td styleCode="Lrule Rrule">Somnolence</td> <td styleCode="Rrule">4%</td> <td styleCode="Rrule">15%</td> </tr> <tr> <td styleCode="Lrule Rrule">Diarrhea</td> <td styleCode="Rrule">4%</td> <td styleCode="Rrule">6%</td> </tr> <tr> <td styleCode="Lrule Rrule">Constipation</td> <td styleCode="Rrule">3%</td> <td styleCode="Rrule">3%</td> </tr> </tbody> </table>