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Developed under the direction and sponsorship of Teva Neuroscience, Inc.
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For adults with tardive dyskinesia (TD)
or Huntington’s disease (HD) chorea.
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AUSTEDO XR® and AUSTEDO® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with HD.
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Please see additional Safety below.
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Brooke Kempf,
MSN, PMHNP-BC
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As you know, it is important to consider potential drug-drug interactions when choosing a VMAT2 inhibitor for patients with TD.
The metabolic profile of AUSTEDO XR allows for few restrictions related to drug-drug interactions1; this means that your patients can increase their dose toward effective and tolerable TD control while continuing to take concomitant medications that are strong CYP inhibitors and inducers.1
Please see below to learn more about this metabolic profile and to hear how a patient with TD was able to stay on her seizure medication while taking AUSTEDO. I hope this information is useful as you determine the right treatment approach for your patients.
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Scroll down to learn more about using AUSTEDO XR with concomitant medications.
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IMPORTANT SAFETY INFORMATION
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Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. 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. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
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Please see additional Important Safety Information below and full Prescribing Information, including Boxed Warning.
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Only with AUSTEDO XR: ability to increase once-daily dose in patients taking strong CYP inhibitors and inducers1,2*
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Metabolic profile allows for few restrictions related to drug-drug interactions (DDIs)1
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For a list of medications that can help determine potential DDIs with your patients’ concomitant treatments, see the Flockhart Table™.
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AIMS, Abnormal Involuntary Movement Scale; VMAT2, vesicular monoamine transporter 2.
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*
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36 mg/day maximum dose for patients taking strong CYP2D6 inhibitors (or poor CYP2D6 metabolizers); 48 mg/day maximum dose for all others.1
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†
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Statistically significant AIMS improvement in AIM-TD at Week 12 in the 24 mg/day and 36 mg/day dosing arms (-3.2 and -3.3 reduction, respectively, vs -1.4 with placebo). Patients in the pivotal studies received the AUSTEDO BID formulation.1
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‡
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Based on studies in healthy patients. For patients with congenital long QT syndrome or arrhythmias associated with prolonged QT interval, all VMAT2 inhibitors should be avoided. Caution should be used for patients taking drugs that prolong the QT interval.1,2
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INDICATIONS AND USAGE
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AUSTEDO XR® (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.
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IMPORTANT SAFETY INFORMATION (Continued)
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Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.
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Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.
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QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.
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Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.
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Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
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Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
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Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.
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Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.
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Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.
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Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.
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Please see full Prescribing Information, including Boxed Warning.
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See study designs at AUSTEDOhcp.com.
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REFERENCES: 1. AUSTEDO XR® (deutetrabenazine) extended-release tablets and AUSTEDO® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. Ingrezza® (valbenazine) capsules. Prescribing Information. San Diego, CA: Neurocrine Biosciences, Inc.
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