Deutetrabenazine (du-tet-ra-BEN-a-zeen)

Treats tardive dyskinesia and chorea caused by Huntington disease.

Brand Name(s):

Austedo, Austedo Tardive Dyskinesia Titration Pack 12mg, Austedo XR, Austedo XR Titration Kit

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet and the extended-release tablet whole with water. Do not crush, break, or chew it.
• Tablet: It is best to take this medicine with food or milk.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you stop taking this medicine for more than 7 days, do not take another dose until you talk to your doctor.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine and an MAO inhibitor (MAOI) within 14 days of each other.
• Do not use this medicine if you are using reserpine. Wait at least 20 days after stopping reserpine before starting deutetrabenazine.
• Do not use this medicine if you are using tetrabenazine or valbenazine. Take deutetrabenazine one day after stopping tetrabenazine.
• Some medicines can affect how deutetrabenazine works. Tell your doctor if you are using any of the following:
  • Medicine for heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine to treat an infection (including moxifloxacin)
  • Medicine to treat depression (including bupropion, fluoxetine, paroxetine)
  • Medicine to treat mental illness (including chlorpromazine, haloperidol, olanzapine, risperidone, thioridazine, ziprasidone)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart disease, a slow heartbeat, or heart rhythm problems (including QT prolongation), or a history of breast cancer.
• This medicine may cause a new or worsening depression or changes in mood or behavior in patients with Huntington disease. Tell your doctor if you have a history of depression or suicidal thoughts.
• This medicine may cause the following problems:
  • Changes in heart rhythm, including QT prolongation
  • Neuroleptic malignant syndrome (a nerve disorder that could be life-threatening)
  • Akathisia (a movement disorder), including agitation and restlessness
  • Parkinsonism (a movement disorder)
• This medicine may cause drowsiness, trouble with thinking, or trouble with controlling movements. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dizziness, lightheadedness, or fainting
• Fever, sweating, confusion, fast or uneven heartbeat, seizures, muscle stiffness
• Problems with balance or walking, stiffness, shaking
• Trouble breathing, swallowing, or speaking
• Trouble sitting still, feeling restless, nervous, or irritable
• Unusual changes in mood or behavior, thoughts of hurting yourself or others
• Worsening depression, trouble sleeping, racing thoughts

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting
• Dry mouth, sore throat
• Sleepiness, unusual drowsiness, tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088