Austedo Dosage

Dosing Information

The dose of AUSTEDO is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. When first prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor), the recommended starting dose of AUSTEDO is 6 mg administered orally once daily for patients with Huntington’s disease and 12 mg per day (6 mg twice daily) for patients with tardive dyskinesia.

• The dose of AUSTEDO may be increased at weekly intervals in increments of 6 mg per day to a maximum recommended daily dosage of 48 mg.
• Administer total daily dosages of 12 mg or above in two divided doses.
• Administer AUSTEDO with food [see Clinical Pharmacology (12.3)].
• Swallow AUSTEDO whole. Do not chew, crush, or break tablets.

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Switching Patients from Tetrabenazine (XENAZINE®) to AUSTEDO

Discontinue tetrabenazine (XENAZINE®) and initiate AUSTEDO the following day. The recommended initial dosing regimen of AUSTEDO in patients switching from tetrabenazine (XENAZINE®) to AUSTEDO is shown in Table 1.

After patients are switched to AUSTEDO, the dose may be adjusted at weekly intervals [see Dosage and Administration (2.1)].

Dosage Adjustment with Strong CYP2D6 Inhibitors

In patients receiving strong CYP2D6 inhibitors (e.g., quinidine, antidepressants such as paroxetine, fluoxetine, and bupropion), the total daily dosage of AUSTEDO should not exceed 36 mg (maximum single dose of 18 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Dosage Adjustment in Poor CYP2D6 Metabolizers

In patients who are poor CYP2D6 metabolizers, the total daily dosage of AUSTEDO should not exceed 36 mg (maximum single dose of 18 mg) [see Use in Specific Populations (8.7)].

Discontinuation and Interruption of Treatment

Treatment with AUSTEDO can be discontinued without tapering. Following treatment interruption of greater than one week, AUSTEDO therapy should be re-titrated when resumed. For treatment interruption of less than one week, treatment can be resumed at the previous maintenance dose without titration.