People with uncontrolled movement problems can have a harder time doing everyday tasks such as speaking, reading, writing, and cooking, which can cause a loss of independence. This may cause people to become self-conscious and anxious in social settings.
Austedo (aw-STED-oh) was approved in 2017 and is the first medicine approved to treat both tardive dyskinesia and chorea caused by Huntington’s disease.
How Does It Work for Chorea and Tardive Dyskinesia?
Chorea is an uncontrolled movement disorder caused by a hereditary condition called Huntington’s disease. A hereditary condition is a condition that is passed down from your parents. Huntington’s disease causes nerve cells in the brain to break down and cause thinking, emotional, and movement problems.
Tardive dyskinesia (TD) is a disorder that can cause repetitive movements such as twitching, shaking, or jerking in the arms, legs, face (including eyes and mouth), and torso. Certain medicines such as antipsychotics that are used to treat mental health conditions and medicines that are used to treat stomach issues can cause TD.
Monoamine neurotransmitters such as dopamine, serotonin, norepinephrine, and histamine work to carry messages from one cell to the next, including muscle and nerve cells. When too much of these neurotransmitters are signaled by your cells, it can cause movement that you cannot control. Austedo works to lower the amount of neurotransmitters sent by the cells, which in turn can lead to fewer uncontrolled movements.
How Do I Take It?
Austedo comes as a regular tablet and an extended-release tablet (Austedo XR). An extended-release tablet works over a longer period of time and can lower the number of times you have to take the medicine every day. Austedo comes as a 6-milligram, 9-milligram, and 12-milligram tablet. The lowest dose of Austedo XR is 6 milligrams, and the highest dose is 48 milligrams, with the doses in between this range increasing by 6 milligrams.
Your health care provider may start you on a dose of Austedo called a starting dose. They may gradually increase your dose every week for a few weeks up to a maintenance dose. Your maintenance dose is the dose that improves your movement symptoms and will generally be the dose you take every day. Everyone’s maintenance dose is different. In order to steadily increase your dose when you first start Austedo, your health care provider may prescribe you a titration kit.
The Austedo XR titration kit contains a 4-week supply of a few different doses of Austedo. It allows you to start at a lower dose and increase your dose every week as you go through the kit. Take Austedo as prescribed by your health care provider.
Austedo can be taken either once or twice a day, depending on the dose your health care provider prescribes you. Austedo is taken with food. If your dose is 12 milligrams or above per day, your health care provider may ask you to take it two times a day. Austedo XR is taken once a day with or without food.
The starting dose of Austedo and Austedo XR is usually 12 milligrams per day. Do not crush, chew, or break the tablet. Swallow the tablet whole with water. If you are taking the Austedo XR tablet, the tablet may not dissolve completely in your body after all the medicine has been released, and you may see the tablet in your stool.
How Was It Studied?
Austedo was studied across three clinical studies – one study in people with chorea and two studies in people with TD – to look at how safe and effective the medicine was.
In the clinical study that looked at Austedo in people with chorea, 90 people diagnosed with Huntington’s disease took either Austedo, at doses between 6 milligrams and 48 milligrams per day, or a placebo containing no medicine over a 12-week period. The study looked at the total maximal chorea score, which measures how severe a person’s chorea symptoms are, with a lower score indicating little to no chorea. The average age of people in the study was 54 years old. About 92% of people in the study were White Americans, with the race of the remaining people in the study unknown. The average dose that people received in the study was 40 milligrams per day.
In the two clinical studies that looked at Austedo in people with TD, the first clinical study looked at 298 people with TD who took either Austedo at a dose of 12, 24, or 36 milligrams per day or a placebo over a 12-week period. The study looked at the change in their Abnormal Involuntary Movement Scale (AIMS) score, which looks at the severity of TD, with a lower score indicating an improvement in symptoms. The average age of people in the study was 56 years old. About 79% of people were White Americans, with the race of the remaining people in the study unknown.
The second clinical study in people with TD looked at 117 people with TD who took either Austedo at doses between 12 milligrams and 48 milligrams per day or a placebo over a 12-week period of time. The study looked at the change in AIMS score. The average age of people in the study was 55 years old. About 70% of people were White Americans, with the race of the remaining people in the study unknown. The average dose that people received in the study was 38 milligrams per day.
What Benefits Were Seen?
Chorea. People who took Austedo had a greater improvement in their total maximal chorea score from baseline to week 12 (-4.4 in the Austedo group vs -1.9 in the placebo group). That means Austedo showed more improvement in people’s uncontrolled movement symptoms, compared to the placebo.
Tardive dyskinesia. People who took Austedo had a greater improvement in their AIMS score. In the first study, in the Austedo group, the improvement in the AIMS score is as follows: -3.3 in the 36-milligram group, -3.2 in the 24-milligram group, -2.1 in the 12-milligram group; and in the placebo group, the improvement was -1.4 from baseline. In the second study, the improvement in the AIMS score from baseline to week 12 was -3 in the Austedo group vs. -1.6 in the placebo group That means Austedo showed more improvement in people’s uncontrolled movement symptoms, compared to the placebo.
How Can I Tell if It Is Working?
Austedo works to lower the amount of uncontrolled movements in people with chorea and TD. You should start to see less uncontrolled movement anywhere from a few weeks to a few months after taking Austedo. When you first start Austedo, your health care provider will start you on a low dose and will keep increasing the dose of the medicine, as often as weekly, until your symptoms improve. Some people may need a lower dose to manage their symptoms and may start to see their symptoms improve quicker. Some people may need a higher dose to manage their symptoms, and may not see their symptoms improve until a later time, as their health care provider continues to increase their dose. Talk to your health care provider if you feel that your symptoms are not improving or are getting worse. Your doctor may increase your dose, add on another medicine, or change you to a different medicine.
What Are the Possible Side Effects, and How Can I Manage Them?
The most common side effects seen with Austedo in people with chorea are drowsiness, diarrhea, dry mouth, and tiredness.
The most common side effects seen with Austedo in people with TD are infection in the nose or throat, sore throat, common cold symptoms, and trouble sleeping.
Austedo can cause drowsiness and tiredness. It is important not to drive or perform any activities that require you to be alert until you know how the medicine affects you.
Diarrhea can happen when taking Austedo. It is important that you drink plenty of fluid so that you do not become dehydrated. Certain foods, such as bananas, rice, and toast, can help. Taking anti-diarrheal medicines may also help.
Dry mouth can happen when taking Austedo. There are certain things that you can do to help ease this, including sipping water regularly, using a humidifier, breathing through your nose instead of your mouth, and limiting caffeine and sugar-free gum
Infection in the nose or throat, sore throat, or the common cold may happen while taking Austedo. Over-the-counter medicines may help manage your symptoms.
Austedo can cause trouble sleeping. There are techniques that may help manage this. Drinking less caffeine, including soda or coffee, trying to stick to a sleep schedule, and limiting screen time before bedtime can help.
Talk to your health care provider if any of these symptoms do not improve or get worse.
What Types of Drug Interactions Can Happen?
There are certain medicines that you should not take while you are taking Austedo. These medicines include monoamine oxidase inhibitors (MAOIs), reserpine, tetrabenazine, and valbenazine.
Reserpine is a medicine that treats high blood pressure. It should not be taken while you are taking Austedo and within 20 days of stopping reserpine.
MOAIs such as isocarboxazid, phenelzine, selegiline, and tranylcypromine are medicines that are used to treat depression or Parkinson’s disease. Austedo should not be taken with an MAOI or within 14 days of stopping an MAOI.
Tetrabenazine is used to treat chorea in Huntington’s disease, and valbenazine is used to treat TD.
Medicines called CYP2D6 inhibitors can cause an increase of Austedo in the blood, which can increase the risk of side effects. These medicines include bupropion, fluoxetine, and paroxetine, which are used for anxiety and depression, and quinidine, which is used to treat an irregular heartbeat (arrhythmia) and malaria. Your health care provider may lower the dose of Austedo if you are taking it with a medicine that is classified as a CYP2D6 inhibitor.
Taking Austedo with medicines called antipsychotics, such as aripiprazole, or dopamine antagonists, such as haloperidol, can increase your risk of having slow, stiff movements and slight shaking, a condition called parkinsonism. It can also cause neuroleptic malignant syndrome (NMS) which can cause muscle stiffness, and akathisia, which is a condition that makes it hard for you to sit still.
Austedo can make you feel drowsy. Taking Austedo with other medicines that can make you feel drowsy, such as Benadryl, can make you feel drowsier. Drinking alcohol with Austedo can also cause you to feel more drowsy. It is not recommended to drink alcohol while taking Austedo.
Talk to your health care provider about all the medicines you are taking.
Is There a Cost Savings Program?
There is a free trial offer provided by the drugmaker that may allow you to receive a one-time, 30-day supply of Austedo if you are just starting on the medicine. There is also a cost savings program that may allow you to pay as little as $0 monthly for your Austedo prescription. Whether you are eligible depends on the type of insurance you have. If you are taking Austedo for chorea, you can find out more at www.austedo.com/huntingtons-chorea/financial-support. If you are taking Austedo for TD, you can find out more at www.austedo.com/tardive-dyskinesia/financial-support. You can also call 888-483-8279.
