Austedo Xr Patient Titration Kit (Oral)
Deutetrabenazine is used in adults to treat involuntary muscle movements (chorea) caused by Huntington's disease. Deutetrabenazine is not a cure for Huntington's disease and will not treat other symptoms of this condition.
Deutetrabenazine is also used in adults to treat symptoms of tardive dyskinesia. Tardive dyskinesia causes repetitive muscle movements in the face, tongue, or other parts of the body that cannot be controlled.
Deutetrabenazine may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Austedo Xr Patient Titration Kit (Oral)?
You should not use deutetrabenazine if you are allergic to it, or if you have:
- Huntington's disease and untreated or uncontrolled depression;
- Huntington's disease and thoughts of suicide or hurting yourself;
- if you are taking tetrabenazine or valbenazine; or
- liver disease.
Do not use deutetrabenazine if you have taken reserpine in the past 20 days, or if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.
Tell your doctor if you have or have ever had:
- depression, anxiety, nervousness, anger, or agitation;
- mental illness or psychosis;
- suicidal thoughts or actions;
- breast cancer;
- a heart rhythm disorder;
- long QT syndrome (in you or a family member);
- an electrolyte imbalance (such as low blood levels of potassium or magnesium); or
- liver disease.
People with Huntington's disease may have a higher risk of depression and suicidal thoughts or actions. Taking deutetrabenazine may further increase this risk. However, the benefits of taking this medicine (improvement of uncontrolled movements) may outweigh any suicidal risks.
Taking deutetrabenazine may cause symptoms similar to Parkinson's disease (tremors, shaking, stiffness, problems with balance or coordination, or falls). Ask your doctor about your risk.
Your doctor will need to check your progress on a regular basis. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.
It is not known if deutetrabenazine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Austedo Xr Patient Titration Kit (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may actually be signs that your Huntington's disease is progressing. Your doctor will need to check your progress on a regular basis.
Some people have depression or thoughts about suicide while taking deutetrabenazine. Tell your doctor right away if you have any sudden changes in mood or behavior, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, or thoughts about hurting yourself.
You may feel faint while taking deutetrabenazine. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.
Call your doctor at once if you have:
- severe restlessness or agitation;
- falls, tremors, shaking;
- problems with balance or coordination; or
- severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
Common side effects may include:
- tiredness, drowsiness;
- dry mouth;
- runny or stuffy nose, sore throat;
- sleep problems (insomnia); or
- diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Austedo Xr Patient Titration Kit (Oral) if I’m pregnant or breastfeeding?
It is not known if deutetrabenazine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Austedo Xr Patient Titration Kit (Oral)?
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Drinking alcohol with this medicine can cause side effects.
Dosage Guidelines & Tips
How to take Austedo Xr Patient Titration Kit (Oral)?
Use Austedo Xr Patient Titration Kit (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
If you are switching from a similar medicine called tetrabenazine, take your first dose of deutetrabenazine on the day after your last dose of tetrabenazine.
Take deutetrabenazine tablet with food and with a full glass of water.
You may take deutetrabenazine extended release tablet with or without food and with a full glass of water.
Swallow the tablet or extended release tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet or extended release tablet whole.
The extended release tablet is made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.
Do not stop this medicine without your doctor's advice. If you stop taking deutetrabenazine for longer than 1 week, do not start taking it again without your doctor's advice.
Store at room temperature away from moisture and light. Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.