AUSTEDO™ (deutetrabenazine; SD-809)
AUSTEDO Rx
Generic Name and Formulations:

Deutetrabenazine 6mg, 9mg, 12mg; tabs.

Company:

Teva Pharmaceuticals
Indications for AUSTEDO:

Huntington's chorea. Tardive dyskinesia.

Adult:

Swallow whole. Take with food. Individualize. 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:

Not established.

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.

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. Reeva luate periodically. Poor CYP2D6 metabolizers. Pregnancy. Nursing mothers.

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.

Pharmacological Class:

Vesicular monoamine transporter 2 (VMAT2) inhibitor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Tabs—60