Austedo (Deutrabenazine)
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Fact Table
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| Formula | C19H21D6NO3 (deuterated) ˜?C19H27NO3 conventional notation :contentReference[oaicite:0]{index=0} |
| License | Austedo (brand of Deutetrabenazine) — approved by U.S. Food and Drug Administration (FDA) April?2017 for chorea in Huntington’s disease, and later for tardive dyskinesia. :contentReference[oaicite:5]{index=5} |
| Bioavailability | At least ~80% oral absorption (extent of absorption =?80?%). :contentReference[oaicite:6]{index=6} |
| Legal status | Prescription only (Rx) in the U.S. and other jurisdictions. :contentReference[oaicite:7]{index=7} |
| Chemical Name | (RR,?SS)-1,3,4,6,7,11b-hexahydro-9,10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. :contentReference[oaicite:8]{index=8} |
| Elimination half-life | Approximately 9–10?hours for total active metabolites (a+ß-HTBZ) in healthy/treated populations. :contentReference[oaicite:9]{index=9} |
| Dosage (Strength) | Oral tablets (IR): starting ~6?mg twice daily with food, titrated up to 48?mg/day in divided doses; Extended-Release (XR) tablets: starting ~12?mg once daily, titrated weekly to up to 48?mg once daily (in U.S.). :contentReference[oaicite:10]{index=10} |
| Pregnancy | Use only if clearly needed; limited data available. (U.S. Pregnancy Category not currently assigned) :contentReference[oaicite:11]{index=11} |
| Brands | Austedo®, Austedo?XR® (by Teva Pharmaceuticals USA) :contentReference[oaicite:13]{index=13} |
| Protein binding | Active metabolites (a-HTBZ?&?ß-HTBZ): ~60–68% and ~59–63% respectively in vitro. :contentReference[oaicite:14]{index=14} |
| PubChem CID | 73437646 :contentReference[oaicite:15]{index=15} |
| MedlinePlus | a617022 :contentReference[oaicite:16]{index=16} |
| ChEBI | (Not listed) — deuterated form not currently in ChEBI with unique ID |
| ATC code | N07XX16 (VMAT2 inhibitor) :contentReference[oaicite:17]{index=17} |
| DrugBank | DB12161 :contentReference[oaicite:18]{index=18} |
| KEGG | D10701 :contentReference[oaicite:19]{index=19} |
| Routes of administration | By mouth (oral tablets, immediate-release and extended-release) :contentReference[oaicite:20]{index=20} |
Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease and tardive dyskinesia in adults. By reducing the amount of dopamine released into nerve terminals, Austedo helps modulate the hyperkinetic movements characteristic of these disorders. The presence of deuterium in deutetrabenazine improves its metabolic stability and pharmacokinetic profile compared to tetrabenazine, leading to a more favorable dosing regimen.
Directions
Austedo should be administered orally, with food, to enhance absorption. Treatment typically begins at a low dose with gradual titration based on patient response and tolerability. The maximum recommended dose for Huntington’s chorea is 48 mg per day, while for tardive dyskinesia, it is also 48 mg per day. Dosage adjustments may be required in patients who are poor CYP2D6 metabolizers or are taking strong CYP2D6 inhibitors. Austedo must not be abruptly discontinued without medical supervision.
Ingredients
Each Austedo tablet contains deutetrabenazine as the active pharmaceutical ingredient. Inactive ingredients may include lactose monohydrate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, and magnesium stearate. The specific composition may vary by tablet strength. Deutetrabenazine is a deuterated form of tetrabenazine, with the molecular formula C19H21D6NO3.
Cautions
Caution is advised in patients with a history of depression or suicidal ideation, as Austedo may increase the risk of such symptoms. Regular monitoring of mood and behavior is recommended throughout treatment. Concomitant use of other CNS depressants, including alcohol, may exacerbate sedation and cognitive impairment. Patients should be evaluated for QT prolongation risk when taking Austedo, particularly those with a history of cardiac arrhythmias or those using QT-prolonging medications.
Contraindications
Austedo is contraindicated in patients with Huntington's disease who are actively suicidal or have untreated or inadequately treated depression. It is also contraindicated in individuals with hepatic impairment and in those currently taking monoamine oxidase inhibitors (MAOIs) or reserpine. A minimum of 20 days should elapse after discontinuing reserpine before starting Austedo.
Side Effects
Common and serious side effects associated with Austedo may include:
- Somnolence
- Diarrhea
- Dry mouth
- Fatigue
- Insomnia
- Anxiety
- Depression
- Akathisia
- Parkinsonism
- Suicidal ideation (particularly in Huntington's patients)
Patients experiencing signs of serious adverse reactions should seek immediate medical attention.
Frequently Asked Questions about Austedo (Deutetrabenazine)
What is Austedo used for?
Austedo is prescribed to treat chorea associated with Huntington’s disease and tardive dyskinesia in adults. It helps manage involuntary movements by regulating dopamine levels in the brain.
How does Austedo work?
Austedo is a vesicular monoamine transporter 2 (VMAT2) inhibitor. It reduces the amount of dopamine available in nerve terminals, which helps decrease abnormal, uncontrolled movements.
How should Austedo be taken?
Austedo is taken orally, usually once or twice daily with food. The dose is typically started low and increased gradually based on individual response and tolerability. It should not be split, crushed, or chewed.
What are the common side effects of Austedo?
Common side effects include drowsiness, dry mouth, diarrhea, fatigue, and insomnia. Some patients may also experience anxiety or restlessness during treatment.
Can Austedo cause depression or suicidal thoughts?
Yes, Austedo may increase the risk of depression and suicidal thoughts, especially in people with Huntington’s disease. Patients should be monitored closely for changes in mood, behavior, or mental health.
Who should not take Austedo?
Austedo should not be used in patients with hepatic impairment, untreated or inadequately treated depression, suicidal ideation, or by those taking monoamine oxidase inhibitors (MAOIs) or reserpine within the past 20 days.
How long does it take for Austedo to work?
Improvements in movement symptoms may be noticed within a few weeks, but full effects can take up to 8 weeks or longer, depending on dose adjustments and individual response.
Does Austedo interact with other medications?
Yes, Austedo can interact with drugs that affect CYP2D6 enzyme activity, such as fluoxetine or paroxetine. Dose adjustments may be needed when taken with these or other centrally acting drugs.
What should I do if I miss a dose?
If a dose is missed, it should be taken as soon as remembered unless it's close to the next scheduled dose. In that case, skip the missed dose and resume the regular schedule without doubling up.
Is Austedo safe to use long term?
Austedo is considered safe for long-term use under medical supervision. Regular monitoring is essential to manage side effects, mental health risks, and ensure the medication remains effective.
