In the USA, GRANISOL (granisetron HCl) is indicated for the prevention of:

• Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
• Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

Selected Safety Information:

• GRANISOL (granisetron HCl) is contraindicated in patients with known hypersensitivity to the drug or any of its components.
• QT prolongation has been reported with granisetron. Therefore, GRANISOL (granisetron HCl) Oral Solution should be used in caution with patients with pre-existing arrhythmias or cardiac conduction disorders, as this might lead to clinical consequences. Patients with cardiac disease, on cardio-toxic chemotherapy, with concomitant electrolyte abnormalities and/or on concomitant medications that prolong the QT interval are particularly at risk.
• Safety and effectiveness in pediatric patients have not been established.
• The most common side effects observed with administration of granisetron were headache, asthenia, constipation, diarrhea, dyspepsia, and abdominal pain.
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