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INDICATION AND IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole)
It is not known if REXULTI is safe and effective in people under 18 years of age.IMPORTANT SAFETY INFORMATION:
Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of patients with dementia-related psychosis.
Contraindication: Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI. Allergic reactions have included rash, facial swelling, hives and itching, and anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.REXULTI may cause serious side effects, including:
Uncontrolled body movements (tardive dyskinesia). REXULTI may cause movements that you cannot control in your face, tongue or other body parts. Tardive dyskinesia may not go away, even if you stop taking REXULTI. Tardive dyskinesia may also start after you stop taking REXULTI.
Problems with your metabolism such as:
high blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or having a family history of diabetes), your healthcare provider should check your blood sugar before you start taking REXULTI and during your treatment.Call your healthcare provider if you have any of these symptoms of high blood sugar while taking REXULTI:
Do not drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects you. REXULTI may make you feel drowsy.
Avoid drinking alcohol while taking REXULTI.Before taking REXULTI, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take or recently have taken, including prescription medicines, over-the-counter medicines, vitamins and herbal supplements.
REXULTI and other medicines may affect each other causing possible serious side effects. REXULTI may affect the way other medicines work, and other medicines may affect how REXULTI works.
Your healthcare provider can tell you if it is safe to take REXULTI with your other medicines. Do not start or stop any medicines while taking REXULTI without talking to your healthcare provider first.
The most common side effect of REXULTI includes weight gain.
Tell your healthcare provider if you experience abnormal muscle spasms or contractions, which may be a sign of a condition called dystonia.
These are not all the possible side effects of REXULTI. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about your health or medicines, including side effects.