Drug Detail:Austedo (Deutetrabenazine [ doo-tet-ra-ben-a-zeen ])
Generic Name: DEUTETRABENAZINE 6mg
Drug Class: VMAT2 inhibitors
Dosing Information
The dose of AUSTEDO XR and AUSTEDO is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. Table 1 displays the recommended dosage and important administration instructions of AUSTEDO XR and AUSTEDO when first prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor).
Table 1: Recommended Dosage and Important Administration Instructions for AUSTEDO XR and AUSTEDO
| | AUSTEDO XR extended-release tablet |
AUSTEDO tablet |
| Recommended Starting Dosage | 12 mg once daily (12 mg per day) |
6 mg twice daily (12 mg per day) |
| Recommended Dose Titration | The dosage of AUSTEDO XR or AUSTEDO may be increased at weekly intervals in increments of 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg [see Clinical Trials (14.1, 14.2)]. | |
| Important Administration Instructions |
|
|
| Switching Between AUSTEDO and AUSTEDO XR | When switching between AUSTEDO tablets (twice daily) and AUSTEDO XR extended-release tablets (once daily), switch to the same total daily dosage. | |
Switching Patients from Tetrabenazine to AUSTEDO XR or AUSTEDO
Discontinue tetrabenazine and initiate AUSTEDO XR or AUSTEDO the following day. The recommended initial dosing regimen of AUSTEDO XR or AUSTEDO in patients switching from tetrabenazine to AUSTEDO XR or AUSTEDO is shown in Table 2.
Table 2: Recommended Initial Dosing Regimen when Switching from Tetrabenazine to AUSTEDO XR or AUSTEDO
| Current tetrabenazine daily dosage |
Initial regimen of AUSTEDO XR extended-release tablet | Initial regimen of AUSTEDO tablet |
|---|---|---|
|
12.5 mg |
6 mg once daily |
6 mg once daily |
|
25 mg |
12 mg once daily |
6 mg twice daily |
|
37.5 mg |
18 mg once daily |
9 mg twice daily |
|
50 mg |
24 mg once daily |
12 mg twice daily |
|
62.5 mg |
30 mg once daily |
15 mg twice daily |
|
75 mg |
36 mg once daily |
18 mg twice daily |
|
87.5 mg |
42 mg once daily |
21 mg twice daily |
|
100 mg |
48 mg once daily |
24 mg twice daily |
After patients are switched to AUSTEDO XR or 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, the total daily dosage of AUSTEDO XR or AUSTEDO should not exceed 36 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 XR or AUSTEDO should not exceed 36 mg [see Use in Specific Populations (8.7)].
Discontinuation and Interruption of Treatment
Treatment with AUSTEDO XR or AUSTEDO can be discontinued without tapering. Following treatment interruption of greater than one week, AUSTEDO XR or 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.
