Warnings: Suicidal Thoughts and Behaviors; and Increased Mortality in Elderly Patients with Dementia-related Psychosis

• Monoamine Oxidase Inhibitors (MAOI): Because of the risk of serotonin syndrome, do not use MAOIs intended to treat psychiatric disorders with SYMBYAX or within 5 weeks of stopping treatment with SYMBYAX. Do not use SYMBYAX within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start SYMBYAX in a patient who is being treated with linezolid or intravenous methylene blue. (4.1) • Pimozide: Do not use. Risk of QT interval prolongation (4.2, 5.17, 7.7, 7.8) • Thioridazine: Do not use. Risk of QT interval prolongation. Do not use thioridazine within 5 weeks of discontinuing SYMBYAX (4.2, 5.17, 7.7, 7.8) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SYMBYAX safely and effectively. See full prescribing information for SYMBYAX. SYMBYAX (olanzapine and fluoxetine hydrochloride) capsule for oral use Initial U.S. Approval: 2003