SANCUSO is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the patch. Granisetron may mask a progressive ileus and/or gastric distention caused by the underlying condition. Mild application-site reactions have occurred; remove the patch if severe reaction or a generalized skin reaction occurs. Patients should avoid direct exposure of application site to natural or artificial sunlight by covering with clothing while wearing the patch and for 10 days after removing it. The most common adverse reaction in patients receiving SANCUSO is constipation (5.4%). SANCUSO contains granisetron. Healthcare professionals should avoid prescribing any additional products that contain granisetron. No clinically relevant drug interactions have been reported in clinical studies with SANCUSO. The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. If symptoms of serotonin syndrome occur, discontinue SANCUSO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if SANCUSO is used concomitantly with other serotonergic drugs.
To report suspected adverse reactions, contact ProStrakan, Inc. at 1-800-SANCUSO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.