Posology : מינונים

2. DOSAGE AND ADMINISTRATION
2.1Dosing 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 12 mg per day (6 mg twice daily) for patients with Huntington’s disease or 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.
• Placebo-controlled clinical trials demonstrated that the average daily dose after titration was 40 mg per day for patients with Huntington’s disease and 38.3 mg per day for patients with tardive dyskinesia [see Clinical Trials (14.1, 14.2)].
• 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.

2.2 Switching Patients from Tetrabenazine to AUSTEDO
Discontinue tetrabenazine and initiate AUSTEDO the following day. The recommended initial dosing regimen of AUSTEDO in patients switching from tetrabenazine to AUSTEDO is shown in Table 1.

Table 1: Recommended Initial Dosing Regimen when Switching from Tetrabenazine to AUSTEDO
Current tetrabenazine                     Initial regimen of daily dosage                             AUSTEDO
12.5 mg                              6 mg once daily
25 mg                               6 mg twice daily
37.5 mg                              9 mg twice daily
50 mg                              12 mg twice daily
62.5 mg                             15 mg twice daily
75 mg                              18 mg twice daily
87.5 mg                             21 mg twice daily
100 mg                              24 mg twice daily

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

2.3 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)].

2.4 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)].

2.5 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.

3. DOSAGE FORMS AND STRENGTHS
AUSTEDO tablets are available in the following strengths:
• The 6 mg tablets are round, purple-coated tablets, with “SD” over “6” printed in black ink on one side.
• The 9 mg tablets are round, blue-coated tablets, with “SD” over “9” printed in black ink on one side.
• The 12 mg tablets are round, beige-coated tablets, with “SD” over “12” printed in black ink on one side.