• Austedo is a brand (trade) name for deutetrabenazine which is an oral prescription medication approved to treat Huntington’s chorea and tardive dyskinesia (TD).
• Austedo (deutetrabenazine) works by blocking the action of VMAT2 which is a protein that controls the transfer of chemical messengers (neurotransmitters) in the brain between nerves. These neurotransmitters help to control normal body movement or motor function. In movement disorders such as Huntington's chorea or TD, there can be a problem with the VMAT2 system, leading to uncontrolled body movements. By blocking VMAT2, Austedo (deutetrabenazine) decreases the activity of neurotransmitters, which helps to reduce unwanted body movements.
• Austedo belongs to the class of medicines known as vesicular monoamine transporter 2 (VMAT2) inhibitors.

• May be used to treat chorea (involuntary muscle movements) associated with Huntington’s disease.
• May also be used to relieve the symptoms of tardive dyskinesia (TD) in adults.
• Austedo may be discontinued without tapering. Following a dosage interruption of more than one week, re-titration is needed.
• Available in three strengths: 6mg, 9mg, and 12mg.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Somnolence (extreme drowsiness), diarrhea, dry mouth, runny or stuffy nose, sore throat, and fatigue are the most common side effects reported. Symptoms similar to Parkinson's disease have also been reported.
• The usual initial dose is 6mg/day which may be increased at weekly intervals by 6mg/day to a maximum of 48 mg/day. Total daily dosages of more than 12 mg/day should be administered in 2 or more divided doses.
• Do not exceed a total daily dosage of 36mg (maximum single dose 18mg) in people who are CYP2D6-poor metabolizers.
• Does not cure Huntington’s chorea or TD. Austedo may worsen some of the effects of Huntington's disease, such as mood, cognition, rigidity, or functional capacity. It may also increase the risk of inner restlessness or agitation. Monitor for these changes.
• Not suitable for people with liver disease, untreated or uncontrolled depression, or those who have suicidal thoughts.
• May prolong the QT interval but this is usually not clinically significant at usual dosages. The risk of QT prolongation is higher with medications that also prolong the QT interval, low potassium or low magnesium levels, or in people with congenital QT prolongation. Do not administer to people with congenital QT prolongation or a history of cardiac arrhythmias.
• Not approved in people under the age of 18 years.
• Has the potential to cause Neuroleptic Malignant Syndrome (NMS), which has been reported in other drugs that also reduce dopaminergic transmission. Symptoms include a high fever, muscle rigidity, altered mental status, irregular or fast pulse, or sweating.
• May cause hyperprolactinemia which is associated with low levels of estrogen and an increase in osteoporosis. One-third of breast cancers have also been shown to be dependent on prolactin and Austedo should not be used in people with a history of breast cancer.
• Binds to melanin-containing tissues. The clinical relevance of this is not known; however, it may cause long-term ophthalmologic effects.
• Interacts with several other medications and should not be given to people who have taken reserpine in the past 20 days or who have used an MAOI (such as isocarboxazid, linezolid, rasagiline, or selegiline) in the past 14 days. Do not use it in people who have recently taken tetrabenazine (Xenazine) or valbenazine (Ingrezza).
• There is no data about the effects of Austedo on a developing fetus. Animal studies have shown an increase in stillbirths and early death. The effects of Austedo on a breastfeeding infant are also unknown.
• No generic is available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Take Austedo exactly as prescribed by your doctor. Do not take larger or smaller dosages or for longer than recommended. Do not stop suddenly without your doctor's advice.
• Take the tablets with food and with a large glass of water. Austedo is usually taken once or twice a day.
• Swallow the tablets whole do not crush, chew, or break the tablet. If you have difficulty swallowing, tell your doctor. If you forget a dose, take the missed dose as soon as you can. If it is almost time for your next dose, then skip the missed dose.
• If your doctor has switched you from a similar medicine called Xenazine (tetrabenazine), you can take your first dose of Austedo one day after your last dose of Xenazine.
• Tell your doctor about any other conditions you may have (such as depression, suicidal thoughts, breast cancer, heart rhythm disturbances, electrolyte imbalances, or liver disease) or other medications you may have taken recently, such as reserpine (Serpalan, Renese-R), Ingrezza, Xenazine, or MAOI antidepressants. Austedo may not be suitable for you.
• Your heart function may need to be checked regularly using an electrocardiograph (ECG).
• Be alert for changes in behavior including agitation, depressed mood, and suicide-related events, and seek medical advice if changes are apparent.
• Talk to your doctor about any side effects you are experiencing. Austedo may cause side effects similar to Parkinson's disease, such as tremors, stiff muscles, slow movements, or difficulty maintaining balance or walking). Seek urgent medical attention if you have an allergic reaction to Austedo (symptoms include difficulty breathing, hives, swelling of the face or throat), pain or burning when you urinate, changes in your heartbeat, sudden dizziness, severe restlessness or agitation, tremors, muscle stiffness, or other severe side effects.
• Do not drive or operate machinery until the full effects of Austedo are known as it may impair your judgment and affect your ability to drive or operate machinery.
• Tell your doctor or other health care provider about all the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements. Austedo interacts with several medicines and it may not be safe to take them together.
• Tell your doctor if you are pregnant or plan on getting pregnant. It is not known if Austedo harms a developing baby and you will need to talk about the benefits and risks of using this medication while you are pregnant.

• Huntington’s chorea is a rare, hereditary, and fatal disorder of nerve cells in the brain. The associated chorea results in involuntary, random, twisting, or writhing bodily movements, and occurs in 90% of patients with Huntington's disease. In Phase III studies of Huntington’s chorea, average scores for patients in the Austedo group improved by 4.4 units compared to 1.9 units in the placebo group at weeks 9 and 12; the treatment effect of -2.5 units was statistically significant (p< 0.0001).
• Two phase III randomized, double-blind, placebo-controlled studies assessed the effectiveness and safety of Austedo in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia (TD). People taking Austedo were able to continue taking their mental health medications like antipsychotics or antidepressants. Austedo was shown to significantly reduced the involuntary movements of TD after 12 weeks of treatment when compared to placebo (an inactive agent), with improvements beginning as soon as 2 weeks. In one study, the AIMS score (used by researchers and doctors to measure involuntary movements in TD) was reduced by 3.3 points compared to 1.4 points with a placebo.

Medicines that interact with Austedo may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Austedo. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Austedo interacts with over 410 drugs and most of these interactions are considered moderate or major. Common medications that may interact with Austedo include:

• agents used to treat constipation, such as bisacodyl, lactulose, or senna
• albuterol
• antibiotics, such as clarithromycin and ciprofloxacin
• anticonvulsants, such as carbamazepine or phenytoin
• antidepressants, such as amitriptyline, imipramine, nortriptyline, SSRIs (eg, citalopram, fluoxetine, or paroxetine), or MAOIs (such as isocarboxazid, linezolid, rasagiline, or selegiline)
• antifungals, such as itraconazole or ketoconazole
• antipsychotics, such as aripiprazole, clozapine, and thioridazine
• azelastine
• benzodiazepines, such as diazepam
• cisapride
• CYP3A4 strong inhibitors (such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, verapamil, goldenseal, or grapefruit)
• CYP3A4 strong or moderate inducers (such as phenobarbital, phenytoin, rifampicin, rifabutin, St. John's Wort
• duloxetine
• efavirenz
• ketamine
• lithium
• loperamide
• metoclopramide
• mifepristone
• magnesium salts
• multiple sclerosis treatments such as fingolimod
• ondansetron
• opioids, such as alfentanil, codeine, morphine, or oxycodone
• oxytocin
• quinidine
• reserpine
• serotonin modulators, such as nefazodone and trazodone
• some heart medications, such as amiodarone
• strong CYP2D6 inhibitors such as paroxetine, fluoxetine, quinidine, or bupropion. Increases exposure to the active metabolites of Austedo by about 3-fold. Do not exceed a maximum single dose of 18mg or a maximum daily dose of 36 mg/day
• tetrabenazine
• valbenazine
• zolpidem or zopiclone.

Austedo is extensively metabolized to active metabolites, primarily by CYP 2D6 with minor contributions of CYP1A2 and CYP3A4/5. Any inhibitor or inducer of these enzymes may have an effect.

Taking Austedo with alcohol may increase the risk of side effects such as drowsiness, confusion, or difficulty concentrating.

Note that this list is not all-inclusive and includes only common medications that may interact with Austedo. You should refer to the prescribing information for Austedo for a complete list of interactions.