TETRABENAZINE ORAL (XENAZINE) BOXED WARNING: DEPRESSION AND SUICIDALITY XENAZINE can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of XENAZINE must balance the risks of depression and suicidality with the clinical need for control of choreiform movements. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. XENAZINE is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression. (see CONTRAINDICATIONS; WARNINGS - Increased Risk of Depression and Suicidality, and PRECAUTIONS - Information for Patients). HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Check your blood pressure regularly. Inform your doctor if blood pressure is not controlled. * Follow prescribed/recommended diet and exercise program. WARNINGS/PRECAUTIONS: TOP * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR. Other Common Side Effects: TOP Sedation; Low blood pressure; Restlessness; Difficulty swallowing; Unusual tiredness or weakness; Difficulty falling asleep; Nausea; Dizziness when getting up; Sleepiness; Movement problems. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved