This medication is contraindicated in people who are suicidal and in people with untreated or inadequately treated depression.
Austedo treats chorea, a type of involuntary movement caused by Huntington’s disease, as well as tardive dyskinesia, which is a side effect of antipsychotic medications.
Austedo works to reduce the amount of monoamine neurotransmitters (e.g., dopamine) released in the brain from nerve terminals. Dopamine is related to the involuntary movements of tardive dyskinesia and chorea.
This medication comes in tablet form to be taken by mouth.
What Is Austedo Used For?
When used on a daily basis, Austedo helps the symptoms of tardive dyskinesia and chorea caused by Huntington’s disease.
Brand Name(s): Austedo
Administration Route(s): Oral
Drug Availability: Prescription
Therapeutic Classification: Central nervous system agent
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Deutetrabenazine
Dosage Form(s): Tablet
The Food and Drug Administration approved Austedo to treat the symptoms of:
Chorea: Chorea is a recurrent, abrupt, jerking movement of the body. It is one of the symptoms of Huntington’s disease, a progressive neurological disorder that causes movement problems and dementia. Tardive dyskinesia: This condition is characterized by repetitive movements of the face, eyes, mouth, or body. It can develop as a side effect of antipsychotic medications, which are often prescribed for the treatment of schizophrenia, bipolar disorder, or certain gastrointestinal conditions. Tardive dyskinesia does not affect everyone who takes these medications, and it often resolves after stopping the medication causing its symptoms. However, it can sometimes continue after the medication is stopped.
Austedo is a symptomatic treatment that does not cure or reverse the underlying disease. Once you stop taking Austedo, you can expect the involuntary movements to resume. Huntington’s disease is a progressively worsening condition, and your underlying chorea can become more severe during the time that you are taking Austedo.
How to Take Austedo
Take this medication with food and swallow the tablets whole with water. Do not chew, crush, or break the tablets.
Storage
Keep Austedo in its original container, and store it away from light or moisture. Keep it at a standard room temperature of 77 F. You can briefly store this medication in a temperature range of 59 F to 86 F.
Off-Label Uses
Healthcare providers sometimes prescribe drugs off-label for medical conditions that are not listed on the product label. In this case, a health professional determines whether a patient will benefit from taking this medication.
Austedo has been used off-label to control involuntary movements associated with tic disorders.
What Are the Side Effects of Austedo?
This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
Austedo can cause mild to moderate side effects, as well as serious adverse effects. Talk to your healthcare provider about your side effects. Your provider might be able to adjust your medication dose or timing to minimize these effects. You might also benefit from treatment to reduce your symptoms.
Common Side Effects
Common side effects of Austedo can be tolerable for some people; in other cases, they can be distressing.
The most common side effects of Austedo are:
Sleepiness Diarrhea Dry mouth Fatigue Nasopharyngitis (symptoms of a cold) Insomnia
Severe Side Effects
Austedo can cause serious side effects that can be dangerous to your health.
Severe side effects of Austedo include:
Neuroleptic malignant syndrome (NMS): This serious condition causes a fever, confusion, rigid muscles, and alterations in body functions. It requires urgent medical treatment and can be fatal. Parkinsonism: Parkinsonism causes symptoms that resemble those of Parkinson’s disease, such as stiff movements and tremors. QT prolongation: This condition affects the heart rhythm. It may not cause symptoms, but it can cause problems such as lightheadedness or fainting. Your medical provider might monitor your heart rhythm with an electrocardiogram (EKG) while you are taking Austedo. Depression: Severe depression can develop while taking this medication. Suicidal thoughts or action: People who are taking Austedo can have thoughts of suicide or plans of suicide. Your provider may monitor these symptoms periodically while you are taking this medication.
If you or a loved one is taking Austedo, be sure to have a plan regarding urgent medical attention in the event that you experience any of these serious side effects.
Long-Term Side Effects
Austedo leaves the body within a few days of stopping the medication. However, you can have lasting problems due to the serious side effects, especially if they are not treated.
Dosage: How Much Austedo Should I Take?
Modifications
There is not enough research to determine the safety of Austedo use during pregnancy. However, animal studies have shown an increased rate of stillbirths and post-birth mortality. If you are pregnant or plan to become pregnant, discuss how to best manage your medication use with your healthcare provider.
If you experience a serious side effect, you or your provider may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets): For tardive dyskinesia and chorea caused by Huntington’s disease: Adults—At first, 12 milligrams (mg) per day taken in 2 divided doses (6 mg two times a day). Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 48 mg per day. Children—Use and dose must be determined by your doctor.
Additionally, experts don’t know if Austedo passes into breast milk during breastfeeding. Your provider will advise you on the best way to feed your baby during treatment.
Your provider might adjust your dose of Austedo if you take certain medications or do not metabolize certain medications well. These medications are known as CYP2D6 inhibitors (e.g., quinidine, fluoxetine, bupropion, and some antidepressants).
Missed Dose
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your normal dosing frequency. Do not double up on doses.
Overdose: What Happens If I Take Too Much Austedo?
Taking too much Austedo can cause symptoms of:
Acute dystonia (severe muscle contraction) Oculogyric crisis (eye movement deviation) Nausea and vomiting Sweating Extreme tiredness Low blood pressure Confusion Diarrhea Hallucinations (seeing things that are not present) Flushing Tremors
If you have taken too much Austedo, a healthcare professional may monitor you for symptoms, including monitoring your blood pressure and heart rhythm. You would be treated symptomatically as needed.
Precautions
What Are Reasons I Shouldn’t Take Austedo?
You should not take this medication if you are depressed or have thoughts of suicide, since Austedo can make these conditions worse. Before taking Austedo, make sure to let your provider know of any medical conditions.
If someone collapses or isn’t breathing after taking Austedo, call 911 immediately.
Deutetrabenazine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed, especially if they have a condition called Huntington’s disease. If you or your caregiver notice any of these side effects, tell your doctor right away.
Do not take this medicine if you are also taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within 14 days of each other. If you have questions, check with your doctor.
Do not take this medicine if you are also taking reserpine (Serpalan® or Renese®-R). Wait at least 20 days after stopping reserpine before starting deutetrabenazine. If you have questions, check with your doctor.
Do not take this medicine if you are also taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®). Take deutetrabenazine one day after stopping tetrabenazine. If you have questions, check with your doctor.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.
Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
Check with your doctor right away if you have an inability to sit still, need to keep moving, or restlessness. These could be symptoms of a movement disorder called akathisia.
This medicine may cause parkinsonism (a movement disorder). Check with your doctor right away if you have difficulty swallowing, loss of balance control, mask-like face, shuffling walk, slowed movements, slurred speech, stiffness of the arms and legs, tic-like or jerky movements of the head, face, mouth, and neck, or trembling and shaking of the fingers and hands.
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.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If the problem continues or worsens, check with your doctor.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
What Other Medications Interact With Austedo?
You should not take Austedo with:
Tetrabenazine or valbenazineMonoamine oxidase inhibitors (MAOIs)Medications that can cause QT prolongationReserpine (a medication used to treat high blood pressure)Alcohol or sedating drugs
Austedo can interact with paroxetine, fluoxetine, quinidine, and other medications that are considered strong CYP2D6 inhibitors. Your provider might change your Austedo dose if you take any of these medications.
Taking Austedo with dopamine antagonists or antipsychotics can also increase the risk of Parkinsonism.
What Medications Are Similar?
Besides Austedo, other VMAT2 inhibitors include:
Xenazine (tetrabenazine): Used to treat chorea in Huntington’s disease Ingrezza (valbenazine): Used to treat tardive dyskinesia
Your provider might have you switch from one of these medications to another due to the persistence of symptoms, side effects, or health insurance considerations.
If you switch from tetrabenazine to Austedo, you should discontinue tetrabenazine and start your treatment with Austedo the next day. Talk to your prescriber about how to convert your dosing.
How Can I Stay Healthy While Taking Austedo?
There are several important considerations to keep in mind when you use Austedo. This medication can cause serious side effects, and it is important that you get medical attention if you develop signs of serious side effects.
To stay healthy while taking this medication, you should:
Use it as directed. Take your other medications (such as antipsychotics) as directed. Tell your healthcare provider about any side effects that you experience. Maintain consistent care for your psychiatric illness, Huntington’s disease, or gastrointestinal condition. Seek emergency medical attention if you begin to experience any of the serious side effects.
