AUSTEDO Prolonged-release tablet Ref.[116189] Active ingredients: Deutetrabenazine

The initiation and titration of Austedo treatment should be supervised by a physician with experience in drug-induced movement disorders.

Posology

Austedo dosing should be determined individually for each patient, based on adequate reduction of tardive dyskinesia symptoms and tolerability.

Therapy should be initiated at 12 mg once daily for one week. The dose should then be increased to 24 mg once daily for another week. After the second week, it is recommended that the dose be titrated at weekly intervals in increments of 6 mg once daily, based on reduction of tardive dyskinesia symptoms and tolerability. The efficacious dose range is considered to be 24 mg to 48 mg. The maximum recommended daily dose is 48 mg.

In patients receiving strong CYP2D6 inhibitors or who are poor CYP2D6 metabolisers, the daily dose of deutetrabenazine should not exceed 36 mg (see sections 4.5 and 5.2).

A decision to continue treatment with deutetrabenazine should be taken on an individual patient basis.

Treatment can be continued for as long as a therapeutic benefit is observed, and the patient tolerates treatment.

Treatment with deutetrabenazine can be discontinued without the need for tapering off.

Missed doses

If a patient misses doses for less than one week, treatment can be resumed at the current dose. If the patient misses doses for more than one week, Austedo therapy should be restarted at 12 mg once daily.

Special populations

Elderly

There is limited data available on the use of deutetrabenazine in patients ≥65 years of age. Based on the results of population pharmacokinetic analysis, no dose adjustment is required (see section 5.2).

Hepatic impairment

The use of deutetrabenazine in patients with hepatic impairment is contraindicated (see sections 4.3 and 5.2).

Renal impairment

No dose adjustment is necessary in patients with renal impairment (see section 5.2).

Paediatric population

There is no relevant use of Austedo in the paediatric population for the indication of tardive dyskinesia.

Method of administration

For oral use.

The prolonged-release tablets can be taken with or without food. To preserve the prolonged-release properties, the tablets must be swallowed whole with water, not chewed, crushed or divided.

The active substance is contained within a non-absorbable shell designed to release the active substance at a controlled rate. The tablet shell is eliminated from the body. Patients should be advised that they may occasionally notice in their stool something that looks like a tablet.

Experience with doses higher than the recommended maximum daily dose of 48 mg is limited. Isolated cases of deutetrabenazine overdose (up to 240 mg per day) have been derived from post- marketing reports and literature. The most frequently observed symptoms were: somnolence, increase in movements, fatigue, agitation and restlessness, insomnia, and suicidal ideation. One additional case reported in the literature included a patient taking 720 mg who experienced toxic encephalopathy, dyskinesia, and psychomotor hyperactivity.

In case of symptoms suggestive for overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse events and given appropriate symptomatic treatment if necessary. The possible involvement of multiple medicinal products should always be considered. No specific antidote is known. Forced diuresis and dialysis are unlikely to be of benefit.

Austedo 12 mg, 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (treatment initiation pack):

2 years.

Austedo 24 mg prolonged-release tablets (maintenance pack):

3 years.

Austedo 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (maintenance packs):

2 years.

Austedo 12 mg, 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (treatment initiation pack):

Do not store above 30°C.

Austedo 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (maintenance packs):

This medicinal product does not require any special storage conditions.

PVC/PCTFE/PVC-Aluminium blisters.

Austedo 12 mg, 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (treatment initiation pack):

Pack of 42 prolonged-release tablets containing two wallet cards one with 21 (7 × 12 mg, 7 × 24 mg, 7 × 30 mg) and another one with 21 (7 × 36 mg, 7 × 42 mg, 7 × 48 mg) prolonged-release tablets.

Austedo 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (maintenance packs):

Packs of 28 and 84 prolonged-release tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.