What is Austedo (deutetrabenazine) for?
Austedo (deutetrabenazine) is a medicine used to treat adults with chorea associated with Huntington’s disease and tardive dyskinesia1.
Chorea is a disorder characterised by brief, abrupt, irregular, unpredictable, non-stereotyped movements which can affect various body parts, and interfere with speech, swallowing, posture and gait2.
Tardive dyskinesia is a debilitating and often irreversible movement disorder characterised by repetitive and uncontrollable movements of the tongue, lips, face, trunk, and extremities. It can be caused by certain medications used to treat mental health conditions or gastrointestinal conditions3.
How does Austedo (deutetrabenazine) work?
Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor1. A VMAT2 is a protein essential for the release of neurotransmitters into the synaptic cleft — the space between neurons where the communication between neurons takes place6. The precise mechanism by which Austedo (deutetrabenazine) exerts its anti-chorea effects is unknown but it is expected to clear the nerve terminals from neurotransmitters like dopamine, serotonin, norepinephrine, and histamine. This reversible effect seems to be responsible for reducing chorea and tardive dyskinesia1.
Austedo (deutetrabenazine) is the second product approved for the treatment of Huntington’s Disease, the other one being tetrabenazine4. The two medicines have a very similar mechanism of action. The main difference between the two is that Austedo (deutetrabenazine) is metabolised more slowly and thus enables less frequent and lower daily doses, achieving the same effect whilst lowering the risk of side effects. Compared with tetrabenazine, deutetrabenazine has, thus, an improved risk-benefit profile5.
Is Austedo (deutetrabenazine) approved?
Austedo (deutetrabenazine) was approved by:
Food and Drug Administration (FDA) (USA):
April 3, 2017 (chorea associated with Huntington’s Disease4)
August 30, 2017 (treatment of Tardive Dyskinesia3)
How do I take Austedo (deutetrabenazine)?
The dose of Austedo (deutetrabenazine) is determined for each patient based on the reduction of chorea or tardive dyskinesia, and tolerability1.
The recommended starting dose of Austedo (deutetrabenazine) is:
6 mg administered orally once daily for patients with Huntington’s disease
12 mg per day (6 mg twice daily) for patients with tardive dyskinesia.
The dosage has to be adjusted according to the patient’s treatment history.
Patients who are not switching from tetrabenazine
When prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor)1:
increase the dose at weekly intervals in increments of 6 mg per day to a maximum recommended daily dosage of 48 mg
total daily dosages of 12 mg or above should be administered in two divided doses
administer with food and swallow whole. Do not chew, crush, or break tablets.
Patients who are switching from tetrabenazine
Patients who are taking tetrabenazine and are switching to Austedo (deutetrabenazine) should discontinue tetrabenazine and initiate Austedo the following day. The recommended initial dosing depends on the current tetrabenazine daily dosage. Detailed information can be found on the FDA official prescribing information on page 21.
Complete information about Austedo (deutetrabenazine) dosage and administration can be found in the resources section1.
Warning: Austedo (deutetrabenazine) can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of Austedo (deutetrabenazine) 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 physician1.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Austedo (deutetrabenazine)?
Common adverse reactions
Chorea associated with Huntington’s Disease
The most common adverse reactions occurring in more than 8% of Austedo-treated patients1 for chorea associated with Huntington’s disease were:
somnolence
diarrhoea
dry mouth
fatigue.
There was no difference in the number of adverse events among the two groups overall and within psychiatric and nervous system areas, with serious adverse events in one patient per group5.
Tardive Dyskinesia
The most common adverse reactions occurring in more than 8% of Austedo-treated patients1 for Tardive Dyskinesia1 were:
nasopharyngitis
insomnia.
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
increases the risk of depression and suicidal thoughts and behaviour (suicidality)
in patients with Huntington’s disease
QT Prolongation (abnormal heart rhythm)
neuroleptic malignant syndrome (NMS)
akathisia, agitation, restlessness, and parkinsonism
sedation/somnolence.
Use in a specific population
Austedo (deutetrabenazine) can be fatal for a fetus.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.
