Uses
What is Austedo used for?
Austedo is commonly used for the following conditions.
- Chorea, which is a movement disorder that is associated with Huntington’s disease
- Tardive dyskinesia (TD), which is a movement disorder
Austedo may also be used for other conditions as determined by your healthcare provider.
How does Austedo work (mechanism of action)?
Austedo works to lower neurotransmitter levels, which are chemicals in the body that are communicated between cells. This causes less uncontrolled movements.
Learn more about How Austedo Helps Uncontrolled Movements in Huntington’s and Tardive Dyskinesia.
How is Austedo supplied (dosage forms)?
Austedo and Austedo XR are available in the following dosage forms that are taken by mouth.
- 6 mg extended-release oral tablets
- 12 mg extended-release oral tablets
- 24 mg extended-release oral tablets
- 30 mg extended-release oral tablets
- 36 mg extended-release oral tablets
- 42 mg extended-release oral tablets
- 48 mg extended-release oral tablets
- 6 mg oral tablets
- 9 mg oral tablets
- 12 mg oral tablets
How should I store Austedo?
Austedo should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Protect from moisture and light.
If you are taking the Austedo titration kit, do not remove tablets from blister packs until ready to take.
Do not throw away the desiccant canister in the bottle until the last dose of Austedo is taken.
Side Effects
What are the most common side effects of Austedo?
The most common side effects of Austedo seen in people with chorea are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Drowsiness
- Diarrhea
- Dry mouth
- Tiredness
The most common side effects of Austedo seen in people with tardive dyskinesia are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Infection in the nose or throat, sore throat, or common cold symptoms
- Trouble sleeping
There may be other side effects of Austedo that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Austedo?
While less common, the most serious side effects of Austedo are described below, along with what to do if they happen.
Severe Allergic Reactions. Austedo may cause allergic reactions, which can be serious. Stop taking Austedo and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Suicidal Thoughts and Actions. Austedo may cause suicidal thoughts or actions in a small number of people with Huntington’s disease. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.
- New or increased thoughts of suicide or death
- Suicide attempt
- New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior
- Feel sad, unimportant, guilty, hopeless or helpless, irritable, angry, aggressive, sleepy, or tired
- Crying spells or trouble paying attention
- Lost interest in seeing your friends or doing things you used to enjoy
- Sleep a lot less or a lot more than usual
- Feel more or less hungry or notice a big change in your weight
- Thoughts about hurting yourself
Heart Rhythm Changes. Austedo may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take some medicines for other heart rhythm problems. Tell your healthcare provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.
Neuroleptic Malignant Syndrome. Neuroleptic malignant syndrome (NMS) may develop while taking Austedo, which could affect your nervous system and may also lead to death. Call your healthcare provider right away or go to the nearest emergency room if you experience any of the following serious symptoms.
- Fever
- Confusion
- Change in pulse, heart rate, heart rhythm, or blood pressure
- Muscle stiffness
- Increased sweating
Restlessness. Austedo may cause restlessness, a condition that makes it hard to sit still (akathisia), and agitation. Call your healthcare provider if you develop any of these symptoms.
Movement Problems. Austedo can cause slow movements, falls, slight shaking, body stiffness, trouble moving, and trouble keeping your balance. Call your healthcare provider right away if you develop any unusual or uncontrolled movements.
Sleepiness. Austedo can make you sleepy. Do not drive or do other activities that require alertness or coordination until you know how Austedo affects you.
High Prolactin Level (Hyperprolactinemia). Austedo may cause an increased level of the hormone prolactin in your blood. Increased levels of prolactin could lead to fertility or bone problems. Contact your healthcare provider if you have any of the following symptoms.
- Vaginal dryness
- Irregular or no periods
- Production of breastmilk when not pregnant or nursing
- Inability to get or keep an erection
- Enlarged breast size (gynecomastia)
- Decreased muscle and body hair
Tissue Buildup. Austedo can build up in certain tissues of your body, including your skin and eyes. Keep all appointments with your healthcare provider.
Warnings & Precautions
Who should not use Austedo?
Allergies to Ingredients. People who are allergic to any of the following should not take Austedo.
- Austedo
- Deutetrabenazine
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Austedo.
Drug Interactions. Austedo should not be taken while you are using certain other medicines. Before taking Austedo, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Suicidal Thoughts or Actions. Austedo should not be taken if you have Huntington’s disease and have suicidal thoughts or actions or are depressed.
Liver Problems. Austedo should not be taken if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to take this medicine.
What should I know about Austedo before using it?
In Huntington’s disease, Austedo does not cure the cause of uncontrolled movements or treat other symptoms, such as problems with thinking or emotions.
Austedo is taken with food. Whether you take Austedo once or twice a day depends on the dose your healthcare provider prescribes you.
Austedo XR is taken once a day with or without food. The Austedo XR tablet may not fully dissolve in the body after all the medicine has been released and you may see the shell of the tablet in your stool.
Do not crush, chew, or break Austedo.
Austedo can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Austedo affects you.
Do not take Austedo unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Austedo with other people, even if they have the same condition as you. It may harm them.
Keep Austedo out of the reach of children.
What should I tell my healthcare provider before using Austedo?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Austedo is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- A history of mental health conditions such as depression, anxiety, psychosis, or have had suicidal thoughts/suicidal attempts
- Liver problems
- Irregular heart rhythm or heartbeat
- Low potassium or low magnesium levels
- Breast cancer or have had a history of breast cancer
Pregnancy. It is not known if or how Austedo could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. It is not known if Austedo passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Austedo while breastfeeding.
How can I get more information about Austedo?
For more information about Austedo, you can visit the manufacturer’s website at www.austedo.com or call them at 888-483-8279.
Interactions
Does Austedo interact with foods or drinks?
There are no known interactions between Austedo and foods or drinks.
It is unknown if drinking alcohol will affect Austedo. The risk of drowsiness (or sleepiness) may be increased if you drink alcohol while taking Austedo.
Does Austedo interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Austedo.
- Paroxetine (Paxil and others) or fluoxetine (Prozac and others), which is a medicine commonly used for anxiety and depression
- Quinidine, which is a medicine used to treat irregular heart rhythm and malaria
- Bupropion (Wellbutrin SR, Wellbutrin XL, and others), which is a medicine used for depression and to help stop smoking
- Reserpine (within the past 20 days), which is a medicine used to reduce blood pressure
- A monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease
- A dopamine antagonist, which is a medicine commonly used for psychosis or schizophrenia
- An antipsychotic, which is a medicine for certain mental health conditions
- Any other medicine that can cause drowsiness
- Tetrabenazine (Xenazine), which is a medicine used to treat chorea
- Valbenazine (Ingrezza), which is a medicine used to treat tardive dyskinesia
Some other medicines may alter the blood levels of Austedo. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Austedo. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Austedo?
If you or someone else has used too much Austedo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Austedo?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
Tell your healthcare provider if you have not taken Austedo for more than 1 week. Do not take another dose of Austedo until you talk to your healthcare provider.