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Drug Safety-related Labeling Changes (SrLC)

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AUSTEDO (NDA-208082)


Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/24/2021 (SUPPL-9)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Additions underlined

Tourette syndrome

The safety and effectiveness of AUSTEDO have not been established in pediatric patients for the treatment of Tourette syndrome.

Efficacy was not demonstrated in two randomized, double-blind, placebo-controlled studies in pediatric patients aged 6 to 16 years with Tourette syndrome. One study evaluated fixed doses of deutetrabenazine over 8 weeks (NCT03571256); the other evaluated flexible doses of deutetrabenazine over 12 weeks (NCT03452943). The studies included a total of 274 pediatric patients who received at least one dose of deutetrabenazine or placebo. The primary efficacy endpoint in both studies was the change from baseline to end-of-treatment on the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS). The estimated treatment effect of deutetrabenazine on the YGTSS-TTS was not statistically significantly different from placebo in either study. The placebo subtracted least squares means difference in YGTSS-TTS from baseline to end-of-treatment was -0.7 (95% CI: -4.1, 2.8) in the flexible dose study and -0.8 (95% CI: -3.9, 2.3) for the primary analysis in the fixed dose study.

The following adverse reactions were reported in frequencies of at least 5% of pediatric patients treated with AUSTEDO and with a greater incidence than in pediatric patients receiving placebo (AUSTEDO vs placebo): headache (includes: migraine, migraine with aura, and headache; 13% vs 9%), somnolence (includes: sedation, hypersomnia, and somnolence; 11% vs 2%), fatigue (8% vs 3%), increased appetite (5% vs <1%), and increased weight (5% vs <1%).

Chorea associated with Huntington’s disease and Tardive dyskinesia

The safety and effectiveness of AUSTEDO have not been established in pediatric patients for the treatment of chorea associated with Huntington’s disease or for the treatment of tardive dyskinesia.

Juvenile Animal Toxicity Data

Deutetrabenazine orally administered to juvenile rats from postnatal days 21 through 70 (at 2.5, 5, or 10 mg/kg/day) resulted in an increased incidence of tremor, hyperactivity, and adverse increases in motor activity at greater than or equal to 5 mg/kg/day, and reduced body weight and food consumption at 10 mg/kg/day. There was no reproductive or early embryonic toxicity up to the highest dose. All drug-related findings were reversible after a drug-free period. The no observed adverse effect level (NOAEL) in juvenile rats was 2.5 mg/kg/day. These drug-related findings were similar to those observed in adult rats; however, the juvenile rats were more sensitive.

12/02/2020 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 QTc Prolongation

(Additions and/or revisions underlined)

AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO is administered within the recommended dosage range [see Clinical Pharmacology (12.2)].

07/15/2019 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Parkinsonism

(additions underlined)

AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors.

rigidity can develop as part of the underlying disease process in Huntington’s disease, it may be difficult to distinguish between potential drug-induced parkinsonism and progression of underlying Huntington’s disease. Drug-induced parkinsonism has the potential to cause more functional disability than untreated chorea for some patients with Huntington’s disease.

Postmarketing cases of parkinsonism in patients treated with AUSTEDO for tardive dyskinesia have been reported. Signs and symptoms in reported cases have included bradykinesia, gait disturbances, which led to falls in some cases, and the emergence or worsening of tremor. In most cases, the development of parkinsonism occurred within the first two weeks after starting or increasing the dose of AUSTEDO. In cases in which follow-up clinical information was available, parkinsonism was reported to resolve following discontinuation of AUSTEDO therapy.

If a patient develops parkinsonism during treatment with AUSTEDO, the AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)


(additions underlined)

What are the possible side effects of AUSTEDO?

 AUSTEDO can cause serious side effects, including:

  • Parkinsonism. Symptoms of parkinsonism include: slight shaking, body stiffness, trouble moving, trouble keeping your balance, or falls.


(additions underlined)


Inform patients that AUSTEDO may cause Parkinson-like symptoms, which could be severe. Advise patients to consult their healthcare provider if they experience slight shaking, body stiffness, trouble moving, trouble keeping their balance, or falls.

06/06/2018 (SUPPL-2)

Approved Drug Label (PDF)

Boxed Warning

Additions and/or warnings underlined:

AUSTEDO can increase the risk of depression …

4 Contraindications

Additions and/or warnings underlined:

  • With Huntington’s disease who are suicidal …

  • Taking tetrabenazine (XENAZINE®) or valbenazine

5 Warnings and Precautions

Additions and/or warnings underlined:

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) …

5.2 Clinical Worsening and Adverse Events in Patients with Huntington’s Disease

Huntington’s disease is a progressive disorder …

5.3 QTc Prolongation

Tetrabenazine, a closely related VMAT2 inhibitor, causes an increase (about 8 msec) in the corrected QT (QTc) interval.

A clinically relevant QT prolongation may occur …

For patients who are CYP2D6 poor metabolizers or are taking a strong CYP2D6 inhibitor, dose reduction may be necessary. The use of AUSTEDO in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongations.

For patients requiring AUSTEDO doses greater than 24 mg per day who are using AUSTEDO with other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of AUSTEDO or other medications that are known to prolong QTc.

AUSTEDO should also be avoided in patients with congenital long QT syndrome …

5.5 Akathisia, Agitation, and Restlessness

AUSTEDO may increase the risk of akathisia, agitation, and restlessness in patients with Huntington’s disease and tardive dyskinesia.

In a 12-week, double-blind, placebo-controlled trial in Huntington’s disease patients, akathisia, agitation, or restlessness was reported by 4% of patients treated with AUSTEDO, compared to 2% of patients on placebo; in patients with tardive dyskinesia, 2% of patients treated with AUSTEDO and 1% of patients on placebo experienced these events

5.6 Parkinsonism in Patients with Huntington’s Disease

5.7 Sedation and Somnolence

… In a 12-week, double-blind, placebo-controlled trial examining patients with Huntington’s disease, 11% of AUSTEDO- treated patients …

6 Adverse Reactions

Additions and/or revisions underlined:

  • Depression and Suicidality in Patients with Huntington’s disease

  • Parkinsonism in Patients with Huntington’s disease

6.1 Clinical Trials Experience

Patients with Huntington’s Disease

Study 1 was a randomized, 12-week, placebo-controlled study …

Table 2: Adverse Reactions in Patients with Huntington’s Disease (Study 1) Experienced by at Least 4% of Patients on AUSTEDO and with a Greater Incidence than on Placebo

Addition of the following:

Patients with Tardive Dyskinesia

The data described below reflect 410 tardive dyskinesia patients participating in clinical trials. AUSTEDO was studied primarily in two 12-week, placebo-controlled trials (fixed dose, dose escalation). The population was 18 to 80 years of age, and had tardive dyskinesia and had concurrent diagnoses of mood disorder (33%) or schizophrenia/schizoaffective disorder (63%). In these studies, AUSTEDO was administered in doses ranging from 12-48 mg per day. All patients continued on previous stable regimens of antipsychotics; 71% and 14% respective atypical and typical antipsychotic medications at study entry.

The most common adverse reactions occurring in greater than 3% of AUSTEDO-treated patients and greater than placebo were nasopharyngitis and insomnia. The adverse reactions occurring in

>2% or more patients treated with AUSTEDO (12-48 mg per day) and greater than in placebo patients in two double-blind, placebo-controlled studies in patients with tardive dyskinesia (Study 1 and Study 2) are summarized in Table 3.

Table 3: Adverse Reactions in 2 Placebo-Controlled Tardive Dyskinesia Studies (Study 1 and Study 2) of 12-week Treatment on AUSTEDO Reported in at Least 2% of Patients and Greater than Placebo Please see label for complete information.

One or more adverse reactions resulted in a reduction of the dose of study medication in 4% of AUSTEDO-treated patients and in 2% of placebo-treated patients.

7 Drug Interactions

7.3 Reserpine

Additions and/or revisions underlined:

… Prescribers should wait for chorea or dyskinesia to reemerge …

7.7 Concomitant Tetrabenazine or Valbenazine

Additions and/or revisions underlined:

AUSTEDO is contraindicated in patients currently taking tetrabenazine or valbenazine.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)


Additions and/or revisions underlined:

Risk of Depression and Suicide in Patients with Huntington’s Disease

Addition of the following:

Prolongation of the QTc Interval

Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations. Advise patients to inform physicians that they are taking AUSTEDO before any new drug is taken.