Austedo XR contains the active ingredient deutetrabenazine, which is a vesicular monoamine transporter 2 (VMAT2) inhibitor. It is available in an extended-release tablet formulation with dosage strengths ranging from 6 mg to 48 mg, and for oral administration. The inactive ingredients include ammonium hydroxide, black iron oxide, magnesium stearate, and polyethylene glycol, among others. Austedo XR is designed to release deutetrabenazine at a controlled rate using osmotic pressure.

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you miss your medication for more than 1 week, you should not restart your medication at the same dose. Contact your care team for instructions.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Agitation, feeling irritable or restless -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome -Muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, shuffling walk -Thoughts of suicide or self-harm, worsening mood, feelings of depression Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Diarrhea -Drowsiness -Dry mouth -Sore throat -Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Breast cancer -Heart disease -Irregular heartbeat or rhythm -Liver disease -Mental health condition -Suicidal thoughts, plans, or attempt by you or a family member -An unusual or allergic reaction to deutetrabenazine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Cisapride -Dextromethorphan; quinidine -Dronedarone -Ketoconazole -Levoketoconazole -MAOIs, such as phenelzine, tranylcypromine, isocarboxazid, rasagiline, selegiline -Mesoridazine -Pimozide -Quinidine -Reserpine -Safinamide -Tetrabenazine -Thioridazine -Valbenazine This medication may also interact with the following: -Alcohol -Benzodiazepines, such as alprazolam, diazepam, or lorazepam -Bupropion -Certain antihistamines -Certain medications for depression, such as amitriptyline, fluoxetine, paroxetine, or trazodone -Certain medications for seizures, such as phenobarbital or primidone -Medications for certain mental health conditions, such as aripiprazole, risperidone, ziprasidone, haloperidol, or chlorpromazine -Medications that cause drowsiness before a procedure, such as propofol -Medications that help you fall asleep -Medications that relax muscles -Metoclopramide -Opioids for pain or cough -Other medications that cause heart rhythm changes

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. The tablet shell of this medication does not dissolve. This is normal. The tablet shell may appear whole in the stool. This is not a cause for concern.

What are the most serious risks of this medication?

Patients taking this medicine may be at risk for depression. Symptoms of depression include feeling sad, loss of interest in activities, sleeping too little or too much, feeling hopeless, changes in eating habits or hunger, trouble with concentration, and feeling tired all the time. Report mood changes of concern promptly to the treating doctor. This medicine may increase thoughts about suicide. Patients of all ages and their families should watch out for new or worsening thoughts of suicide while taking this medicine. Report behaviors of concern promptly to the treating doctor.