Austedo
Pronunciation: aw-STED-oh
Generic name: deutetrabenazine
Dosage form: Austedo tablets (6 mg, 9 mg, 12 mg)
Drug class: VMAT2 inhibitors
What is Austedo?
Austedo (deutetrabenazine) is used to treat chorea (sudden involuntary movements) caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). It is not a cure for Huntington's disease and will not treat other symptoms of this condition.
Austedo is also used in adults to treat symptoms of tardive dyskinesia (TD), a nervous system disorder. Tardive dyskinesia causes repetitive uncontrolled muscle movements, usually in the face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement).
Austedo's drug class VMAT2 inhibitors (vesicular monoamine transporter 2 inhibitors. It works by changing the activity of certain natural substances in the brain that affect nerves and muscles.
Austedo tablets are taken twice daily with food, and Austedo XR (extended-release tablet) is taken once daily.
How does Austedo work?
Body movement or motor function is controlled in the brain by nerve cells (neurons) that speak to each other by passing chemical messengers (neurotransmitters) from one nerve cell to another nerve cell.
In movement disorders such as Huntington’s disease and tardive dyskinesia there can be a problem with this system and by lowering the amount of chemical messengers between the nerve cells you relieve the uncontrolled movements.
A protein called VMAT2 controls how much chemical messenger is stored in the nerve cell and how much is released. The VMAT2 inhibitors block VMAT2 which means there is a lower amount of neurotransmitter available and therefore reduces the unwanted body movements.
Austedo side effects
Common Austedo side effects may include:
- drowsiness;
- tiredness;
- dry mouth;
- runny or stuffy nose, sore throat;
- sleep problems (insomnia); or
- diarrhea.
Serious Austedo side effects
Get emergency medical help if you have signs of an allergic reaction to Austedo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people have thoughts about suicide while taking Austedo for Huntington's disease. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.
Some side effects may actually be signs that your Huntington's disease is progressing. Your doctor will need to check your progress on a regular basis.
Deutetrabenazine may cause other serious side effects. Call your doctor at once if you have:
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
- severe restlessness or agitation;
- tremors, shaking;
- muscle stiffness;
- problems with balance or coordination; or
- severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Related/similar drugs
What is the cost of Austedo tablets?
The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Austedo price guide or Austedo XR price guide pages for more information about the cost of this medicine.
Austedo Copay Card or Coupon
You may pay as little as $0 out-of-pocket if you qualify for the Austedo copay card. The Coupon or Copay Card helps you save money on prescriptions for this medicine.
Warnings
You should not use Austedo tablets or extended-release tablets if you have liver disease, untreated or uncontrolled depression, or if you have thoughts about suicide.
Do not use this medicine if you have taken reserpine (Serpalan, Renese-R) in the past 20 days, or if you have used an MAO inhibitor (isocarboxazid, linezolid, rasagiline, selegiline, and others) in the past 14 days.
Stay alert to changes in your mood, feelings, thoughts, or behaviors. Report any new or worsening symptoms to your doctor.
Some people have thoughts about suicide while taking Austedo for Huntington’s disease. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.
Your doctor will need to check your progress while you are using Austedo.
Before taking this medicine
You should not use Austedo if you are allergic to the active ingredient, deutetrabenazine, inactive ingredients, or if you have:
- untreated or uncontrolled depression;
- thoughts about suicide or hurting yourself;
- if you have recently taken tetrabenazine or valbenazine; or
- liver impairment.
Do not use this medicine if you have taken reserpine in the past 20 days, or if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
- depression, anxiety, nervousness, or agitation;
- mental illness or psychosis;
- suicidal thoughts or actions;
- breast cancer;
- a heart rhythm disorder;
- long QT syndrome (in you or a family member);
- an electrolyte imbalance (such as low blood levels of potassium or magnesium); or
- liver disease.
People with Huntington's disease may have a higher risk of depression and suicidal thoughts or behaviors. Taking this medicine may further increase this risk. However, the benefits of taking this medicine (improvement in daily living) may outweigh any suicidal risks.
Taking this medicine may cause symptoms similar to Parkinson's disease (resting tremor, stiff muscles, slow movements, difficulty maintaining balance, and walking). Ask your doctor about your risk.
Your doctor will need to check your progress on a regular basis. Your family or caregivers should also watch for sudden changes in your behavior.
Tell your doctor if you are pregnant or breastfeeding.
How should I take this medicine?
Take Austedo as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
If you are switching from a similar medicine called tetrabenazine, take your first dose of Austedo one day after your last dose of tetrabenazine.
Austedo tablets are usually taken twice daily with food and a whole glass of water. Swallow the tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet whole.
You may need medical tests to check your heart function using an electrocardiograph or ECG (sometimes called an EKG).
Do not stop the medicine without your doctor's advice. If you stop taking Austedo for longer than 1 week, do not start taking it again without your doctor's advice.
Store at room temperature away from moisture and heat. Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative.
Austedo dose information
Initial dose: 6 mg twice daily (12 mg per day).
Dose titration: May increase dose in increments of 6 mg/day at weekly intervals, based on reduction of chorea or tardive dyskinesia, and tolerability up to a maximum of 48 mg/day in divided doses.
Maximum Dose: 48 mg/day in divided doses.
Important Administration Instructions:
- Take Austedo tablets with food
- Swallow whole. Do not chew, crush, or break tablets
- Take total daily dosages of 12 mg or above in two divided doses.
Dose modifications: Dose modifications may be required when taking other medications due to drug interactions.
Discontinuation and Interruption of Treatment: Treatment with this medicine can be discontinued without tapering. Following treatment interruption of greater than one week, this therapy should be re-titrated when resumed. For treatment interruption of less than one week, treatment can be resumed at the previous maintenance dose without titration.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include involuntary muscle movements, tremors, rapid eye movements, nausea, vomiting, diarrhea, flushing, sweating, severe drowsiness, confusion, hallucinations, or feeling light-headed.
What should I avoid while taking this medicine?
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Drinking alcohol with this medicine can cause side effects.
What other drugs will affect this medicine?
Austedo can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.
Using Austedo with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Many drugs can interact with the active ingredient deutetrabenazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.
Ingredients
Active ingredient: deutetrabenazine.
Inactive ingredients: 2.5mg tablets; ammonium hydroxide, black iron oxide, n-butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD& C blue #2 lake. The 6 mg tablets also contain FD& C red #40 lake. The 12 mg tablets also contain FD& C yellow #6 lake.
Manufacturer
Teva Neuroscience, Inc.: Parsippany, NJ 07054 USA.
Popular FAQ
Austedo vs Xenazine: How do they compare?
Deutetrabenazine (Austedo, Austedo XR) and tetrabenazine (Xenazine) primarily differ in their uses, chemical structure, pharmacokinetics and cost. The addition of deuterium (2H) to Austedo lengthens the duration of action and may reduce some side effects. Overall, the drugs are fairly similar with regards to drug class, warnings, and drug interactions.
Continue readingHow long does it take for Austedo to work?
Austedo (deutetrabenazine) starts working within two weeks, according to results of phase III clinical trials, which were conducted in patients with chorea associated with Huntington’s disease and tardive dyskinesia. Continue reading
What condition is Austedo used to treat?
Austedo (deutetrabenazine) is an oral prescription medication approved to treat Huntington’s chorea and tardive dyskinesia (TD). Austedo is classified as a vesicular monoamine transporter 2 (VMAT2) inhibitor. VMAT2 a protein that controls transfer of chemical messengers (neurotransmitters) between nerves in the brain between. These neurotransmitters help to control normal body movement or motor function. Continue reading
More FAQ
References
- First Time Use of SD-809 in Huntington Disease (First-HD)
- Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD)
- Addressing Involuntary Movements in Tardive Dyskinesia (AIM-TD)
- Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease A Randomized Clinical Trial
- Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial
- Austedo Package Insert
- Austedo Copay Card Terms and Conditions
- National Institute of Neurological Disorders and Stroke - Huntington’s Disease
- National Institute of Neurological Disorders and Stroke - Tardive Dyskinesia
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