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This document outlines crucial safety information and warnings for individuals considering the use of Austedo (deutetrabenazine), particularly those with Huntington's disease or other pre-existing conditions. Understanding these risks and speaking with a healthcare provider is essential before starting treatment.

• Depression and Suicidal Thoughts: Austedo may elevate the risk of depression and suicidal thoughts, especially in patients with Huntington's disease. Regular evaluations by your healthcare provider for signs of depression or suicidal ideation are advised. If you or your caregivers observe any new or worsening mental health symptoms, such as anxiety or irritability, contact your provider immediately. Discontinuation of the medication may be necessary if these symptoms persist.

• Huntington's Disease Symptom Monitoring: Austedo may cause side effects that resemble worsening symptoms of Huntington's disease, such as mood changes or cognitive difficulties. Periodic assessments by your provider will help determine if these changes are due to the medication or disease progression. Dosage adjustments may be required.

• Heart Rhythm Changes (QT Prolongation): Austedo may rarely affect heart rhythm, potentially leading to QT prolongation. Patients with existing heart rhythm issues or those taking medications that also prolong QT should avoid Austedo. Seek immediate medical attention if you experience symptoms like chest pain or dizziness.

• Neuroleptic Malignant Syndrome (NMS): Although not reported with Austedo, there is a theoretical risk of developing NMS, a serious condition linked to similar medications. Consult your provider if you are taking antipsychotic drugs or other medications that lower dopamine levels.

• Restlessness and Movement Disorders (Parkinsonism): Some users may experience restlessness or movement disorders, such as akathisia. Report any such symptoms to your healthcare provider.

• High Prolactin Levels: While not specifically studied with Austedo, similar medications can increase prolactin levels, potentially leading to issues like breast growth or milk production. Notify your provider if you experience these symptoms.

Contraindications: Austedo should not be used in the following conditions due to potential health risks:

• Untreated or inadequately treated depression in those with Huntington's disease.
• Existing liver problems.

• Recent or current use of MAOIs, tetrabenazine, or Ingrezza.

  Before starting Austedo, discuss any of these conditions with your healthcare provider to ensure safe and effective treatment. In case of overdose or severe reactions, seek emergency medical assistance immediately.

Some individuals may experience common side effects when taking this medication, which are generally mild. These include drowsiness, tiredness, dry mouth, trouble sleeping, dizziness, nausea, and vomiting. Sleepiness and tiredness occur in about 11% and 9% of users, respectively. Other common effects are diarrhea and urinary tract infections, each affecting around 9% and 7% of users. Difficulty sleeping is also noted in about 7% of individuals. If these symptoms persist or worsen, it is advisable to discuss them with a healthcare provider.

In some cases, users may report additional effects such as runny nose, sore throat, and other cold-like symptoms, affecting about 4% of those taking the medication. Though these are typically not severe, it is important to seek advice if they become troublesome.

Serious side effects, though rare, require immediate medical attention. These include agitation, restlessness, symptoms resembling Parkinson’s disease, and mental changes like new or worsening depression or suicidal thoughts. Uncontrolled muscle movements and signs of increased prolactin hormone, such as changes in menstrual cycles or decreased sexual ability, are also serious. Another rare but severe condition is neuroleptic malignant syndrome (NMS), marked by fever, muscle stiffness, severe confusion, and a rapid heartbeat. Any signs of a serious allergic reaction, such as rash, swelling, severe dizziness, or trouble breathing, demand urgent medical care. Always consult your healthcare provider for any unlisted effects or concerns.