Austedo

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. 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. 4 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. 2). 2). 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.

Summary of the safety profile Most commonly reported adverse reactions associated with deutetrabenazine were somnolence (11%), diarrhoea, dry mouth, and fatigue (each 9%). Somnolence may occur more frequently at the beginning of treatment and decrease with treatment continuation.

The most serious adverse reactions were depression and dysthymic disorder (2%). Tabulated list of adverse reactions Adverse reactions from clinical studies and post-marketing reports are presented according to MedDRA system organ classification.

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Frequency categories are based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) and not known (cannot be estimated from the available data).

8 The following adverse reactions have been identified for deutetrabenazine (see Table 1).

Table 1:

List of adverse reactions System Organ Class Frequency Adverse Reaction Infections and infestations Common Urinary tract infection Nasopharyngitis Psychiatric disorders Common Depression* Dysthymic disorder* Anxiety Insomnia Agitation** Restlessness** Nervous system disorders Very common Somnolence Common Akathisia** Uncommon Parkinsonism Gastrointestinal disorders Common Diarrhoea Constipation Dry mouth General disorders and administration site conditions Common Fatigue Injury, poisoning and procedural complications Common Contusion * Preferred terms depression and dysthymic disorder were grouped for frequency calculation.

** Preferred terms agitation, restlessness and akathisia were grouped for frequency calculation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

8). Patients should be closely monitored for the emergence of such adverse reactions. Patients and their caregivers should be informed of the risks and instructed to report any concerns to their doctor immediately. If depression does not resolve, discontinuing treatment with deutetrabenazine should be considered.

1). 5) and in patients with congenital long QT syndrome, bradycardia, hypokalaemia, hypomagnesaemia or a history of cardiac arrhythmias. 5). Main symptoms of NMS are mental changes, rigidity, hyperthermia, autonomic dysfunction and elevated creatinine phosphokinase levels.

If NMS is suspected, deutetrabenazine should be discontinued immediately and appropriate symptomatic treatment should be initiated. 8). Patients receiving deutetrabenazine should be monitored for signs and symptoms of restlessness and agitation, as these may be indicators of developing akathisia.

If a patient develops akathisia during treatment with deutetrabenazine, the dose should be reduced; some patients may require discontinuation of therapy. 7). 5). 8). If a patient develops parkinsonism, the deutetrabenazine dose should be reduced and discontinuation of treatment should be considered if the event does not resolve.

g. skin and eye), it could accumulate in these tissues over time. This raises the possibility that deutetrabenazine may cause toxicity in these tissues after extended use. The clinical relevance of deutetrabenazine’s binding to melanin-containing tissues is unknown.

e. is essentially ‘sodium-free’. This medicinal product contains sunset yellow FCF and/or allura red AC which may cause allergic reactions (see section 2). 6

1. 2). 5). 5). 5).