austedo - monthly prescribing referencemedia.empr.com/documents/298/austedo_74255.pdfnew product...
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New Product Slideshow
Austedo (deutetrabenazine)
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Introduction
Brand name: Austedo
Generic name: Deutetrabenazine
Pharmacological class: Vesicular monoamine transporter 2 (VMAT2) inhibitor
Strength and Formulation: 6mg, 9mg, 12mg; tablets
Manufacturer: Teva Pharmaceuticals
How supplied: Bottle—60
Legal Classification: Rx
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Indications
Huntington’s chorea
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Dosage & Administration
Swallow whole
Take with food
Individualize
Initially 6mg once daily
May titrate at weekly intervals by 6mg/day increments; max 48mg/day
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Dosage & Administration
Total daily dose ≥12mg: give in 2 divided doses
Switching from tetrabenazine: see full labeling
Concomitant strong CYP2D6 inhibitors or poor CYP2D6 metabolizers: max 36mg/day (max 18mg/dose)
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Considerations for Special Populations
Pregnancy: Inadequate data on the developmental risk associated with Austedo in pregnant women
Nursing mothers: Consider benefits and adverse effects on the breastfed infant
Pediatric: Not established Elderly: Insufficient number of subjects
included in studies
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Contraindications
Depression
Suicidal ideation
Hepatic impairment
During or within 14 days of discontinuing an MAOI
During or within 20 days of discontinuing reserpine
Concomitant tetrabenazine
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Warnings/Precautions
Increased risk of depression and suicidality; monitor for emergence or worsening of depression, suicidality, or unusual changes in behavior
Avoid in congenital long QT syndrome or history of cardiac arrhythmias
Bradycardia
Hypokalemia
Hypomagnesemia
Monitor for neuroleptic malignant syndrome (NMS); discontinue and treat if develops
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Warnings/Precautions
Reduce dose or discontinue if akathisia or parkinsonism develops
History of breast cancer
Consider discontinuing if symptomatic hyperprolactinemia develops
Reevaluate periodically
Poor CYP2D6 metabolizers
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Interactions
See Contraindications
Avoid concomitant other drugs that can cause QT prolongation (eg, chlorpromazine, haloperidol, thioridazine, ziprasidone, moxifloxacin, quinidine, procainamide, amiodarone, sotalol)
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Interactions
Potentiated by strong CYP2D6 inhibitors (eg, quinidine, paroxetine, fluoxetine, bupropion)
Increased risk of parkinsonism, NMS, akathisia with dopamine antagonists or antipsychotics
Additive CNS effects with alcohol or other sedatives
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Adverse Reactions
Somnolence
Diarrhea
Dry mouth
Fatigue
UTI
Insomnia
Anxiety
Constipation
Contusion
NMS
QTc prolongation
Akathisia
Agitation
Restlessness
Parkinsonism
Possible ophthalmic effects
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Mechanism of Action
Deutetrabenazine exerts its action after getting metabolized to α-dihydrotetrabenazine (HTBZ) and β-HTBZ, its major metabolites that reversibly inhibit VMAT2, which results in decreased uptake of monoamines (eg, dopamine, serotonin, norepinephrine, histamine) into synaptic vesicles and depletion of monoamine stores
The exact mechanism of deutetrabenazine’s anti-chorea effects is unknown, but it is believed to be related to the reversible monoamine depletion
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Clinical Trials
The efficacy of Austedo was evaluated in a randomized, double-blind, placebo-controlled, multicenter trial (Study 1) in 90 patients with Huntington’s chorea
Patients were randomized to receive either Austedo or placebo for 12 weeks, followed by a 1-week washout period
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Clinical Trials
In the Austedo group, patients initially received a dose of 6mg once daily and titrated upward in 6mg increments at weekly intervals until a satisfactory dose was achieved, intolerable side effects occurred, or until a maximum dose of 48mg/day was reached
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Clinical Trials
The primary efficacy endpoint was the Total Maximal Chorea (TMC) Score, an item of the Unified Huntington’s Disease Rating Scale, which rates chorea from 0−4 (0 represents no chorea) for 7 different parts of the body (total score range: 0−28)
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Clinical Trials
At endpoint, treatment with Austedo showed improvement in the TMC Score as compared to placebo
A change in total score from baseline to maintenance period (average of Week 9 and Week 12) was approximately 4.4 units in Austedo-treated patients vs. 1.9 units in the placebo group
The treatment effect of –2.5 units was statistically significant (P<0.0001)
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Clinical Trials
Furthermore, 51% of patients treated with Austedo rated their overall Huntington’s disease symptoms as “Much Improved” or “Very Much Improved” in a patient-rated global impression of change assessment, vs. 20% in the placebo group
In a physician-rated clinical global impression of change assessment, 42% vs. 13%, respectively, rated their symptoms as “Much Improved” or “Very Much Improved” at the end of treatment
For more clinical trial data, see full labeling
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New Product Monograph
For more information view the product monograph available at:
http://www.empr.com/austedo/drug/34665/