See Important Safety Information below, & Medication Guide here: bit.ly/3uMjEDi. AUSTEDO XR/AUSTEDO can cause depression, suicidal thoughts, or actions in patients with HD. Don’t use if you have liver problems; are taking reserpine, tetrabenazine, or valbenazine.
Hear experts discuss the benefits of treating tardive dyskinesia (TD) with AUSTEDO, such as treatment results and dosing information.
APPROVED USES
AUSTEDO XR is a prescription medicine that is used to treat:
• the involuntary movements (chorea) of Huntington’s disease (HD). AUSTEDO XR/AUSTEDO does not cure the cause of the involuntary movements, & it does not treat other symptoms of HD, such as problems with thinking or emotions.
• movements in the face, tongue, or other body parts that cannot be controlled TD (tardive dyskinesia).
It is not known if AUSTEDO XR/AUSTEDO is safe & effective in children.
IMPORTANT SAFETY INFORMATION
AUSTEDO XR/AUSTEDO can cause serious side effects in people with HD, including: depression, suicidal thoughts, or suicidal actions. Do not start taking AUSTEDO XR/AUSTEDO if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is especially important when AUSTEDO XR/AUSTEDO is started & when the dose is changed. Call your doctor right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of suicide.
Do not take AUSTEDO XR/AUSTEDO if you:
• have HD & are depressed or have thoughts of suicide.
• have liver problems.
• are taking reserpine. Do not take medicines that contain reserpine with AUSTEDO XR/AUSTEDO. If your doctor plans to switch you from taking reserpine to AUSTEDO XR/AUSTEDO, you must wait at least 20 days after your last dose of reserpine before you start taking AUSTEDO XR/AUSTEDO.
• are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking AUSTEDO XR/ AUSTEDO. Do not start AUSTEDO XR/AUSTEDO if you stopped taking an MAOI in the last 14 days. Ask your doctor or pharmacist if you are not sure.
• are taking tetrabenazine. If your doctor plans to switch you from tetrabenazine to AUSTEDO XR/AUSTEDO, take your first dose of AUSTEDO XR/AUSTEDO on the day after your last dose of tetrabenazine.
• are taking valbenazine.
Other possible serious side effects include:
• Irregular heartbeat (QT prolongation). AUSTEDO XR/AUSTEDO increases your chance of having certain changes in the electrical activity in your heart. These changes can lead to a dangerous abnormal heartbeat. Taking AUSTEDO XR/AUSTEDO with certain medicines may increase this chance.
• Neuroleptic Malignant Syndrome. Call your doctor right away & go to the nearest emergency room if you develop these signs & symptoms that do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating.
• Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia.
• Parkinsonism. Symptoms include: slight shaking, body stiffness, trouble moving, trouble keeping your balance, or falls.
Sleepiness (sedation) is a common side effect of AUSTEDO XR/AUSTEDO. While taking AUSTEDO XR/AUSTEDO, do not drive a car or operate dangerous machinery until you know how AUSTEDO XR/AUSTEDO affects you. Drinking alcohol & taking other drugs that may also cause sleepiness while you are taking AUSTEDO XR/AUSTEDO may increase any sleepiness caused by AUSTEDO XR/AUSTEDO.
The most common side effects of AUSTEDO in people with HD include sleepiness (sedation), diarrhea, tiredness, & dry mouth.
The most common side effects of AUSTEDO in people with TD include inflammation of the nose & throat (nasopharyngitis) & problems sleeping (insomnia).
The most common side effects of AUSTEDO XR are expected to be similar to AUSTEDO in people with HD or TD. These are not all the possible side effects of AUSTEDO XR/AUSTEDO. Call your doctor for advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/me... call 1-800-FDA-1088.
2 июл 2024
