Miscellaneous neurodegenerative disorders:

Indications for: AUSTEDO

Huntington's chorea. Tardive dyskinesia.

Adult Dosage:

Swallow whole. Take with food. Individualize. Huntington's chorea: initially 6mg once daily. Dyskinesia: initially 6mg twice daily. Both: may titrate at weekly intervals by 6mg/day increments; max 48mg/day. Total daily dose ≥12mg: give in 2 divided doses. Switching from tetrabenazine: see full labeling. Concomitant strong CYP2D6 inhibitors or poor CYP2D6 metabolizers: max 36mg/day (max 18mg/dose).

Children Dosage:

Not established.

AUSTEDO Contraindications:

Suicidal, untreated or inadequately treated depression in patients with Huntington's disease. Hepatic impairment. During or within 14 days of discontinuing an MAOI. During or within 20 days of discontinuing reserpine. Concomitant tetrabenazine or valbenazine.

Boxed Warning:

Depression and suicidality in patients with Huntington's disease.

AUSTEDO Warnings/Precautions:

Increased risk of depression and suicidality in Huntington's patients; monitor for emergence or worsening of depression, suicidality, or unusual changes in behavior; consider discontinuing if not resolved. Avoid in congenital long QT syndrome or history of cardiac arrhythmias. Assess QT interval before and after dose increases of Austedo ≥24mg/day or other QT-prolonging drugs. Bradycardia. Hypokalemia. Hypomagnesemia. Monitor for neuroleptic malignant syndrome (NMS); discontinue and treat if develops. Reduce dose or discontinue if akathisia or parkinsonism develops. History of breast cancer. Consider discontinuing if symptomatic hyperprolactinemia develops. Reevaluate periodically. Poor CYP2D6 metabolizers. Pregnancy. Nursing mothers.

AUSTEDO Classification:

Vesicular monoamine transporter 2 (VMAT2) inhibitor.

AUSTEDO Interactions:

See Contraindications. Avoid concomitant other drugs that can cause QT prolongation (eg, chlorpromazine, haloperidol, thioridazine, ziprasidone, moxifloxacin, quinidine, procainamide, amiodarone, sotalol). Potentiated by strong CYP2D6 inhibitors (eg, quinidine, paroxetine, fluoxetine, bupropion); see Adult. Increased risk of parkinsonism, NMS, akathisia with dopamine antagonists or antipsychotics. Additive CNS effects with alcohol or other sedatives.

Adverse Reactions:

Somnolence, diarrhea, dry mouth, fatigue, UTI, nasopharyngitis, insomnia; NMS, QTc prolongation, akathisia, agitation, restlessness, parkinsonism, possible ophthalmic effects.

Generic Drug Availability:


How Supplied: