Austedo (deutetrabenazine) 6 mg/1 TABLET, COATED

Austedo (deutetrabenazine)

Active Ingredient:
deutetrabenazine
Form:
TABLET, COATED
Brand:
Austedo
Origin:
USA

Buy Austedo (deutetrabenazine) deutetrabenazine

Austedo (deutetrabenazine) is an FDA-approved oral medication developed by Teva Neuroscience, Inc. for treating tardive dyskinesia and chorea associated with Huntington's disease. It received orphan drug designation for both indications, recognizing its therapeutic importance in rare movement disorders affecting the central nervous system.

Strength

6 mg/1

Pack Size

60 TABLET, COATED in 1 BOTTLE (68546-170-60)

Manufacturer / TM Owner

Teva Neuroscience, Inc.

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Uses / Indications

  • Austedo is indicated for the treatment of tardive dyskinesia (TD), a potentially irreversible involuntary movement disorder often resulting from long-term antipsychotic medication use, and for chorea associated with Huntington's disease, a progressive neurodegenerative disorder. The drug targets patients experiencing hyperkinetic movement abnormalities characterized by repetitive, involuntary movements of the face, limbs, and trunk. Deutetrabenazine, the active ingredient, functions as a vesicular monoamine transporter 2 (VMAT2) inhibitor, reducing the availability of dopamine and other monoamines in the presynaptic neuron. This mechanism helps diminish the excessive involuntary movements characteristic of both conditions. Austedo is administered orally and represents a significant therapeutic option for patients with limited treatment alternatives, particularly those with TD who cannot tolerate or discontinue causative antipsychotic medications.

Side Effects

  • Common side effects of Austedo include sedation, akathisia, depression, insomnia, and parkinsonism. Serious adverse events include suicidality, neuroleptic malignant syndrome (NMS), akathisia, and hepatic impairment. Patients require baseline and periodic monitoring of liver function tests, as hepatic disease may necessitate dose adjustment. Psychiatric monitoring is essential given the risk of depression and suicidal ideation. Blood pressure monitoring is recommended due to potential hypotensive effects. Regular assessment of movement disorders and neurological status should be conducted throughout treatment to evaluate therapeutic response and detect emerging adverse effects.

Precautions & Warnings

  • Austedo is contraindicated in patients with hepatic impairment, as deutetrabenazine undergoes hepatic metabolism. Caution is warranted in patients with cardiac conduction abnormalities, recent myocardial infarction, or uncontrolled hypertension. The drug carries a black box warning for increased suicidality risk, particularly in patients with depression or psychiatric history. Pregnancy category is not established; use only if benefits outweigh risks. Pediatric safety and efficacy have not been established. Renal impairment does not require dose adjustment, but hepatic impairment necessitates careful dosing consideration. Concurrent use with other CNS depressants may potentiate sedation and should be managed cautiously.

Avoid Interactions

  • Austedo should be used cautiously with strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine), which may increase deutetrabenazine exposure and adverse effects. Concurrent use with other VMAT2 inhibitors is not recommended. CNS depressants, including alcohol, opioids, and sedating medications, may potentiate sedation and impairment. Antipsychotics and other dopamine antagonists may reduce Austedo's efficacy. Monoamine oxidase inhibitors (MAOIs) are contraindicated. Patients should avoid alcohol consumption and inform healthcare providers of all concurrent medications to prevent clinically significant interactions.

Frequently Asked Questions

Austedo is used to treat tardive dyskinesia, an involuntary movement disorder often caused by long-term antipsychotic use, and chorea associated with Huntington's disease. It works by reducing dopamine availability in the brain to decrease excessive involuntary movements. Austedo is an oral medication prescribed when other treatment options are ineffective or not tolerated.

Austedo is administered orally as a tablet, typically starting at 6 mg daily and titrated based on therapeutic response and tolerability, up to a maximum of 48 mg daily. Dosing should be individualized and adjusted gradually to minimize adverse effects. Patients should take Austedo consistently as prescribed by their healthcare provider.

Common side effects include sedation, akathisia (restlessness), depression, insomnia, and parkinsonism. Most side effects are dose-dependent and may improve with dose adjustment or continued use. Serious side effects such as suicidality and neuroleptic malignant syndrome require immediate medical attention.

Austedo is manufactured by Teva Neuroscience, Inc., a subsidiary of Teva Pharmaceutical Industries specializing in neurological medications.

Yes, Austedo has received FDA orphan drug designation for both tardive dyskinesia and Huntington's disease chorea. This designation recognizes its therapeutic importance in treating rare conditions affecting a limited patient population and provides regulatory incentives for development and commercialization.

Published by GNH India Pharmaceuticals Limited

Last updated:

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