Austedo

Generic name: Deutetrabenazine
Drug class: VMAT2 inhibitors

Usage of Austedo

Austedo and Austedo XR (deutetrabenazine) are 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). Deutetrabenazine 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 belongs to a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors. It works by changing the activity of certain natural substances in the brain that affect nerves and muscles.

Austedo is taken twice daily, and Austedo XR (extended-release tablet) is taken once daily.

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. 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 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.

Common Austedo side effects may include:

drowsiness;

tiredness;

dry mouth;

runny or stuffy nose, sore throat;

sleep problems (insomnia); or

diarrhea.

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.

Before taking Austedo

You should not use Austedo if you are allergic to deutetrabenazine, or if you have:

untreated or uncontrolled depression;

thoughts about suicide or hurting yourself;

if you have recently taken tetrabenazine or valbenazine; or

liver disease.

Do not use Austedo 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 Austedo 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 Austedo may further increase this risk. However, the benefits of taking this medicine (improvement in daily living) may outweigh any suicidal risks.

Taking Austedo 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.

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How to use Austedo

Usual Adult Dose for Huntington Disease:

-Initial Dose: 6 mg orally once a day -Maintenance Dose: May increase dose in increments of 6 mg/day at weekly intervals. -Maximum Dose: 48 mg/day in divided doses. Use: For chorea associated with Huntington's disease

Usual Adult Dose for Tardive Dyskinesia:

-Initial Dose: 6 mg orally 2 times a day -Maintenance Dose: May increase dose in increments of 6 mg/day at weekly intervals. -Maximum Dose: 48 mg/day in divided doses Use: For tardive dyskinesia

Comments: -Determine the dose for each patient based on tardive dyskinesia reduction and tolerability. -Administer total daily dosages of 12 mg or more in 2 divided doses. -May discontinue this drug without tapering. -Re-titrate dose when resuming this drug following therapy interruption of greater than 1 week; resume therapy at the previous maintenance dose without titration if treatment interruption is less than 1 week. -For patients at risk for QT prolongation, assess the QT interval before and after increasing total dosage above 24 mg per day.

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. 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.

What other drugs will affect Austedo

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 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.

Popular FAQ

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. During the dose titration phase of these trials a continuous improvement in symptoms was observed. During the dose titration phase of these trials, the dose of Austedo was optimized over six-to-eight weeks or the dose of Austedo was titrated up over four weeks until the maximum dose the patient was assigned to receive was achieved. Continue reading

The main differences between deutetrabenazine (Austedo, Austedo XR) and tetrabenazine (Xenazine) are in their chemical structure and pharmacokinetics. The addition of deuterium to the Austedo compound lengthens the duration of action and may reduce certain side effects compared to Xenazine. Overall, the drugs are fairly similar with regards to drug class, warnings, side effects and potential drug interactions, but differ in their FDA-approved uses. Continue reading

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

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