Austedo

AUSTEDO- deutetrabenazine tablet, coated
AUSTEDO- deutetrabenazine
Teva Neuroscience, Inc.

WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE

AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician.

Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. AUSTEDO is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression [see Contraindications (4) and Warnings and Precautions (5.1 )].

1 INDICATIONS AND USAGE

AUSTEDO® is indicated in adults for the treatment of:

  • chorea associated with Huntington’s disease [see Clinical Studies (14.1)]
  • tardive dyskinesia [see Clinical Studies (14.2)]

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

Table 1: Recommended Initial Dosing Regimen when Switching from Tetrabenazine (XENAZINE®) to AUSTEDO
Current tetrabenazine daily dosage Initial regimen ofAUSTEDO

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.

4 CONTRAINDICATIONS

AUSTEDO is contraindicated in patients:

  • With Huntington’s disease who are suicidal, or have untreated or inadequately treated depression [see Warnings and Precautions (5.1)].
  • With hepatic impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
  • Taking reserpine. At least 20 days should elapse after stopping reserpine before starting AUSTEDO [see Drug Interactions (7.2 )].
  • Taking monoamine oxidase inhibitors (MAOIs). AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI [see Drug Interactions (7.3 )].
  • Taking tetrabenazine (XENAZINE®) or valbenazine [see Drug Interactions (7.6)].

5 WARNINGS AND PRECAUTIONS

5.1 Depression and Suicidality in Patients with Huntington’s Disease

Patients with Huntington’s disease are at increased risk for depression, and suicidal ideation or behaviors (suicidality). AUSTEDO may increase the risk for suicidality in patients with Huntington’s disease.

In a 12-week, double-blind, placebo-controlled trial, suicidal ideation was reported by 2% of patients treated with AUSTEDO, compared to no patients on placebo; no suicide attempts and no completed suicides were reported. Depression was reported by 4% of patients treated with AUSTEDO.

When considering the use of AUSTEDO, the risk of suicidality should be balanced against the need for treatment of chorea. All patients treated with AUSTEDO should be observed for new or worsening depression or suicidality. If depression or suicidality does not resolve, consider discontinuing treatment with AUSTEDO.

Patients, their caregivers, and families should be informed of the risks of depression, worsening depression, and suicidality associated with AUSTEDO, and should be instructed to report behaviors of concern promptly to the treating physician. Patients with Huntington’s disease who express suicidal ideation should be evaluated immediately.

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