Austedo XR, Austedo Patient Titration Kit

Deutetrabenazine

(du tet ra BEN a zeen)

Austedo

This drug may raise the chance of depression and suicidal thoughts or actions in people with Huntington's disease. If you have ever had depression or suicidal thoughts or actions, talk with your doctor. This drug may not be right for you. People who take this drug must be watched closely. Call your doctor right away if you have signs like depression, nervousness, restlessness, grouchiness, panic attacks, or any other changes in feelings, mood, or behavior. Call your doctor right away if you have any thoughts or actions of suicide.

It is used to treat disabling involuntary movements in Huntington's chorea. It is used to treat tardive dyskinesia.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have or have ever had depression or thoughts of suicide. If you have liver disease. If you have ever had a long QT on ECG or other heartbeat that is not normal. If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen. If you are taking reserpine or have taken it within the last 20 days. If you are taking any of these drugs: Tetrabenazine or valbenazine. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. If you have Huntington's disease, your signs can still get worse while you use drugs like this one. Call your doctor right away if you have any signs that are new or worse. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain. Trouble controlling body movements that is new or worse. Change in balance. Shakiness, trouble moving around, or stiffness. Restlessness. Feeling confused. Feeling agitated. Change in eyesight. Dizziness. Enlarged breasts, nipple discharge, not able to get or keep an erection (in males), or period (menstrual) changes (in females). A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out. A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Feeling sleepy. Feeling tired or weak. Diarrhea. Dry mouth. Trouble sleeping. Nose or throat irritation. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take this drug with food. Swallow whole. Do not chew, break, or crush. Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well. If you have trouble swallowing, talk with your doctor.

Take a missed dose as soon as you think about it, with food. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. If you miss 7 days of this drug, call your doctor to find out what to do.

Store at room temperature. Protect from light. Keep lid tightly closed. Store in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.