AUSTEDO Dosage & Rx Info | Uses, Side Effects

Austedo Generic Name & Formulations

Legal Class

General Description

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

Pharmacological Class

Vesicular monoamine transporter 2 (VMAT2) inhibitor.

How Supplied

Tabs—60

Manufacturer

Teva Pharmaceuticals

Generic Availability

Mechanism of Action

The mechanism by which deutetrabenazine exerts its effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals.

Austedo Indications

Indications

Huntington's chorea. Tardive dyskinesia.

Austedo Dosage and Administration

Adult

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

Not established.

Austedo Contraindications

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.

Austedo Boxed Warnings

Boxed Warning

Depression and suicidality in patients with Huntington's disease.

Austedo Warnings/Precautions

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. Risk of long-term ophthalmologic effects due to binding to melanin-containing tissues; consider monitoring. Reevaluate periodically. Poor CYP2D6 metabolizers. Pregnancy. Nursing mothers.

Austedo Pharmacokinetics

Absorption

Following oral administration of deutetrabenazine, the extent of absorption is at least 80%.
Peak plasma concentrations of deutetrabenazine are reached within ~3–4 hours after dosing.
Effect of Food:

Austedo XR: Food had no effect.
Austedo: Peak plasma concentration was increased by approximately 50% in the presence of food.

Distribution

Median volume of distribution: 500 to 730 L.
Plasma protein bound: 60% to 68% (for α-HTBZ); 59% to 63% (β-HTBZ).

Metabolism

Hepatic (CYP2D6 [major]), CYP1A2, CYP3A4/5.

Elimination

Renal (75–86%), fecal (8–11%).
Half-life: ~9 to 10 hours.
Clearance: 65 to 200 L/hour.

Austedo Interactions

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.

Austedo Adverse Reactions

Adverse Reactions

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

Austedo Clinical Trials

See Literature

Austedo Note

Not Applicable

Austedo Patient Counseling