Valbenazine is a drug used to treat a side effect of antipsychotic or neuroleptic medications called tardive dyskinesia.

Tardive dyskinesia is a movement disorder that causes uncontrollable abnormal movements of the jaw, lips and tongue. It is a rare side effect that may occur after long-term use of certain medications that block dopamine receptors, leading to too much dopamine signaling in the brain. These medications are used to treat schizophrenia and other conditions.

Dopamine is a chemical messenger called a monoamine neurotransmitter. It communicates information between nerve cells and and is involved in many bodily functions including movement and mood.

Valbenazine is a type of drug called a VMAT2 (vesicular monoamine transporter 2) inhibitor. It is thought to work by preventing the release of dopamine from small structures (vesicles) within dopamine-producing nerve cells, which reduces extra dopamine signaling in the brain.

Valbenazine is used to treat the symptoms of tardive dyskinesia, but it does not cure the condition. It was approved by the US Food and Drug Administration in 2017.

What is valbenazine used for?

Valbenazine is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

It is not known if valbenazine is safe and effective in children.

• Take valbenazine exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much valbenazine to take and when to take it.
• Do not stop taking valbenazine without talking to your healthcare provider first.
• Valbenazine can be taken with or without food.

• The initial dosage of valbenazine is 40 mg once daily. After one week, the recommended dosage of valbenazine is 80 mg once daily.
• Valbenazine can be taken with or without food.
• The recommended dosage for patients with moderate or severe hepatic impairment is 40 mg once daily.
• The recommended dosage for known CYP2D6 poor metabolizers is 40 mg once daily.
• See the full prescribing information for further information about valbenazine dosing.

Do not take valbenazine if you:

• are allergic to valbenazine, or any of the ingredients in valbenazine. See below for a complete list of ingredients in valbenazine.

What should I tell my doctor before taking valbenazine?

Before taking valbenazine, tell your healthcare provider about all of your medical conditions including if you:

• have liver problems
• have heart disease that is not stable, have heart failure or recently had a heart attack
• have an irregular heart rhythm or heartbeat (QT prolongation, heart arrhythmia)

If you take too much valbenazine, call your poison control center at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Valbenazine may cause serious side effects, including:

• Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how valbenazine affects you.
• Heart rhythm problems (QT prolongation). Valbenazine may cause a heart problem known as QT prolongation. Symptoms of QT prolongation may include:
  • fast, slow, or irregular heartbeat
  • shortness of breath
  • dizziness or fainting
    Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.
• Parkinson-like symptoms. Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance

The most common side effect of valbenazine is sleepiness (somnolence).

Other common side effects include:

• changes in balance (balance problems, dizziness) or an increased risk of falls
• headache
• feelings of restlessness
• dry mouth
• constipation
• blurred vision

These are not all of the possible side effects of valbenazine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Using valbenazine at the same time as a monoamine oxide inhibitor (MAOI) should be avoided. Examples of MAOIs include:

• Isocarboxazid
• Phenelzine
• Selegiline

Taking valbenazine with certain other medicines may cause serious side effects. Do not start any new medicines while taking valbenazine without talking to your healthcare provider first.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.