Austedo

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 5/13/2022
Austedo Side Effects Center

What Is Austedo?

Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington's disease.

What Are Side Effects of Austedo?

Common side effects of Austedo include:

Dosage for Austedo

The starting dose of Austedo is 6 mg once daily. Titrate up at weekly intervals by 6 mg per day to a tolerated dose that reduces chorea, up to a maximum recommended daily dosage of 48 mg (24 mg twice daily).

What Drugs, Substances, or Supplements Interact with Austedo?

Austedo may interact with alcohol or other sedating drugs, paroxetine, fluoxetine, quinidine, bupropion, reserpine, monoamine oxidase inhibitors (MAOIs), dopamine antagonists, antipsychotics, tetrabenazine, antibiotics, and antiarrhythmics. Tell your doctor all medications and supplements you use.

Austedo During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Austedo; it is unknown how it may affect a fetus. It is unknown if Austedo passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Austedo (deutetrabenazine) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Austedo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: crying spells, changes in weight or appetite, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, or if you feel hopeless, guilty, extremely tired, irritable, hostile, aggressive, or have thoughts about suicide or hurting yourself.

Some side effects may actually be signs that your Huntington's disease is progressing. Your doctor will need to check your progress at regular intervals.

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);
  • pain or burning when you urinate;
  • 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 side effects may include:

  • drowsiness;
  • feeling tired;
  • 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.

Read the entire detailed patient monograph for Austedo (Deutetrabenazine Tablets)

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Austedo Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Depression and Suicidality in Patients with Huntington's disease [see WARNINGS AND PRECAUTIONS]
  • QTc Prolongation [see WARNINGS AND PRECAUTIONS]
  • Neuroleptic Malignant Syndrome (NMS) [see WARNINGS AND PRECAUTIONS]
  • Akathisia, Agitation, and Restlessness [see WARNINGS AND PRECAUTIONS]
  • Parkinsonism [see WARNINGS AND PRECAUTIONS]
  • Sedation and Somnolence [see WARNINGS AND PRECAUTIONS]
  • Hyperprolactinemia [see WARNINGS AND PRECAUTIONS]
  • Binding to Melanin-Containing Tissues [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Patients With Huntington's Disease

Study 1 was a randomized, 12-week, placebo-controlled study in patients with chorea associated with Huntington's disease. A total of 45 patients received AUSTEDO, and 45 patients received placebo. Patients ranged in age between 23 and 74 years (mean 54 years); 56% were male, and 92% were Caucasian. The most common adverse reactions occurring in greater than 8% of AUSTEDO-treated patients were somnolence, diarrhea, dry mouth, and fatigue. Adverse reactions occurring in 4% or more of patients treated with AUSTEDO, and with a greater incidence than in patients on placebo, are summarized in Table 2.

Table 2: Adverse Reactions in Patients with Huntington's Disease (Study 1) Experienced by at Least 4% of Patients on AUSTEDO and with a Greater  Incidence than on Placebo

Adverse Reaction AUSTEDO
(N = 45) %
Placebo
(N = 45) %
Somnolence 11 4
Diarrhea 9 0
Dry mouth 9 7
Fatigue 9 4
Urinary tract infection 7 2
Insomnia 7 4
Anxi ety 4 2
Constipation 4 2
Contusion 4 2

One or more adverse reactions resulted in a reduction of the dose of study medication in 7% of patients in Study 1. The most common adverse reaction resulting in dose reduction in patients receiving AUSTEDO was dizziness (4%).

Agitation led to discontinuation in 2% of patients treated with AUSTEDO in Study 1.

Patients With Tardive Dyskinesia

The data described below reflect 410 tardive dyskinesia patients participating in clinical trials. AUSTEDO was studied primarily in two 12-week, placebo-controlled trials (fixed dose, dose escalation). The population was 18 to 80 years of age, and had tardive dyskinesia and had concurrent diagnoses of mood disorder (33%) or schizophrenia/schizoaffective disorder (63%). In these studies, AUSTEDO was administered in doses ranging from 12-48 mg per day. All patients continued on previous stable regimens of antipsychotics; 71% and 14% respective atypical and typical antipsychotic medications at study entry.

The most common adverse reactions occurring in greater than 3% of AUSTEDO-treated patients and greater than placebo were nasopharyngitis and insomnia. The adverse reactions occurring in >2% or more patients treated with AUSTEDO (12-48 mg per day) and greater than in placebo patients in two double-blind, placebo-controlled studies in patients with tardive dyskinesia (Study 1 and Study 2) are summarized in Table 3.

Table 3: Adverse Reactions in2 Placebo-Controlled Tardive Dyskinesia Studies (Study1 and Study 2)of 12-week Treatment on AUSTEDO Reported in at Least 2% of Patients and Greater than Placebo

Preferred Term AUSTEDO
(N=279) (% )
Placebo
(N=131) (% )
Nasopharyngitis 4 2
Insomnia 4 1
Depression/ Dysthymic disorder 2 1
Akathis ia/Agitation/Re stle ssness 2 1

One or more adverse reactions resulted in a reduction of the dose of study medication in 4% of AUSTEDO-treated patients and in 2% of placebo-treated patients.

DRUG INTERACTIONS

Strong CYP2D6 Inhibitors

A reduction in AUSTEDO dose may be necessary when adding astrong CYP2D6 inhibitor in patients maintained on a stable dose of AUSTEDO. Concomitant use of strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) has been shown to increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3fold. The daily dose of AUSTEDO should not exceed 36 mg per day, and the maximum single dose of AUSTEDO should not exceed 18 mg in patients taking strong CYP2D6 inhibitors [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

Reserpine

Reserpine binds irreversibly to VMAT2 and the duration of its effect is several days. Prescribers should wait for chorea or dyskinesia to reemerge before administering AUSTEDO to help reduce the risk of overdosage and major depletion of serotonin and norepinephrine in the central nervous system. At least 20 days should elapse after stopping reserpine before starting AUSTEDO. AUSTEDO and reserpine should not be used concomitantly [see CONTRAINDICATIONS].

Monoamine Oxidase Inhibitors (MAOIs)

AUSTEDO is contraindicated in patients taking MAOIs. AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI [see CONTRAINDICATIONS].

Neuroleptic Drugs

The risk of parkinsonism, NMS, and akathisia may be increased by concomitant use of AUSTEDO and dopamine antagonists or antipsychotics.

Alcoholor Other Sedating Drugs

Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence [see WARNINGS AND PRECAUTIONS].

Concomitant Tetrabenazine or Valbenazine

AUSTEDO is contraindicated in patients currently taking tetrabenazine or valbenazine. AUSTEDO may be initiated the day following discontinuation of tetrabenazine [see DOSAGE AND ADMINISTRATION].

Read the entire FDA prescribing information for Austedo (Deutetrabenazine Tablets)

© Austedo Patient Information is supplied by Cerner Multum, Inc. and Austedo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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