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Austedo XR Prescribing Information
AUSTEDO XR and AUSTEDO are contraindicated in patients:
- With Huntington’s disease who are suicidal, or have untreated or inadequately treated depression[see Warnings and Precautions ].
- With hepatic impairment[see Use in Specific Populations , Clinical Pharmacology ].
- Taking reserpine. At least 20 days should elapse after stopping reserpine before starting AUSTEDO XR or AUSTEDO[see Drug Interactions ].
- Suicidal, or untreated/inadequately treated depression in patients with Huntington’s disease
- Hepatic impairment
- Taking reserpine, MAOIs, tetrabenazine, or valbenazine
Patients with Huntington’s disease are at increased risk for depression, and suicidal ideation or behaviors (suicidality). AUSTEDO XR and AUSTEDO may increase the risk for suicidality in patients with Huntington’s disease.
In a 12-week, double-blind, placebo-controlled trial, suicidal ideation was reported by 2% of patients treated with AUSTEDO, compared to no patients on placebo; no suicide attempts and no completed suicides were reported. Depression was reported by 4% of patients treated with AUSTEDO.
When considering the use of AUSTEDO XR or AUSTEDO, the risk of suicidality should be balanced against the need for treatment of chorea. All patients treated with AUSTEDO XR or AUSTEDO should be observed for new or worsening depression or suicidality. If depression or suicidality does not resolve, consider discontinuing treatment with AUSTEDO XR or AUSTEDO.
Patients, their caregivers, and families should be informed of the risks of depression, worsening depression, and suicidality associated with AUSTEDO XR and AUSTEDO, and should be instructed to report behaviors of concern promptly to the treating physician. Patients with Huntington’s disease who express suicidal ideation should be evaluated immediately.
AUSTEDO XR® and AUSTEDO® are indicated in adults for the treatment of:
- chorea associated with Huntington’s disease [see Clinical Studies ]
- tardive dyskinesia [see Clinical Studies ]
AUSTEDO XR extended-release tablets are available in the following strengths:
- The 6 mg extended-release tablets are round, grey-coated tablets, with “Q6” printed in black ink on one side.
- The 12 mg extended-release tablets are round, blue-coated tablets, with “Q12” printed in black ink on one side.
- The 18 mg extended-release tablets are round, light grey-coated tablets, with “Q18” printed in black ink on one side.
- The 24 mg extended-release tablets are round, purple-coated tablets, with “Q24” printed in black ink on one side.
- The 30 mg extended-release tablets are round, light orange-coated tablets, with “Q30” printed in black ink on one side.
- The 36 mg extended-release tablets are round, light purple-coated tablets, with “Q36” printed in black ink on one side.
- The 42 mg extended-release tablets are round, orange-coated tablets, with “Q42” printed in black ink on one side.
- The 48 mg extended-release tablets are round, pink-coated tablets, with “Q48” printed in black ink on one side.
AUSTEDO tablets are available in the following strengths:
- The 6 mg tablets are round, purple-coated tablets, with “SD” over “6” printed in black ink on one side.
- The 9 mg tablets are round, blue-coated tablets, with “SD” over “9” printed in black ink on one side.
- The 12 mg tablets are round, beige-coated tablets, with “SD” over “12” printed in black ink on one side.
AUSTEDO XR and AUSTEDO are contraindicated in patients:
- With Huntington’s disease who are suicidal, or have untreated or inadequately treated depression [see Warnings and Precautions ].
- With hepatic impairment [see Use in Specific Populations , Clinical Pharmacology ].
- Taking reserpine. At least 20 days should elapse after stopping reserpine before starting AUSTEDO XR or AUSTEDO [see Drug Interactions ].
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 ]
AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (
The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures:
Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.
AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.
AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool.
AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, 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.