Deutetrabenazine tablets

What is this medication?

DEUTETRABENAZINE (DOO tet ra BEN a zeen) is used to treat the involuntary movements caused by tardive dyskinesia or Huntington's disease, also known as Huntington's chorea.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Austedo

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

They need to know if you have any of these conditions:

• heart disease
• history of breast cancer
• history of irregular heartbeat
• liver disease
• mental illness
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• an unusual or allergic reaction to deutetrabenazine, tetrabenazine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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 pediatrician regarding the use of this medicine 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.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• pimozide
• quinidine
• reserpine
• tetrabenazine
• thioridazine
• valbenazine

This medicine may also interact with the following medications:

• antihistamines for allergy, cough and cold
• alcohol
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for sleep
• certain medicines for seizures like phenobarbital, primidone
• dofetilide
• general anesthetics like halothane, isoflurane, methoxyflurane, propofol
• local anesthetics like lidocaine, pramoxine, tetracaine
• medicines that relax muscles for surgery
• narcotic medicines for pain or cough
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• phenothiazines like chlorpromazine, fluphenazine, perphenazine, prochlorperazine, trifluoperazine

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?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Patients and their families should watch out for worsening depression or thoughts of suicide. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

Tell your doctor or health care professional right away if you have any change in your eyesight.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in vision
• feeling faint or lightheaded, falls
• loss of balance or coordination
• suicidal thoughts or other mood changes
• restlessness, pacing, inability to keep still
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
• signs and symptoms of neuroleptic malignant syndrome (NMS) such as confusion; fast or irregular heartbeat; high fever; increased sweating; uncontrolled head, mouth, neck, arm, or leg movements; stiff muscles
• tremors

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• anxious
• constipation
• diarrhea
• dizziness
• dry mouth
• tiredness
• 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.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

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.