Valbenazine oral capsules

What is this medicine?

VALBENAZINE (val BEN a zeen) is used to treat the involuntary movements caused by tardive dyskinesia.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

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

• loss of balance or coordination, falls

• 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 high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination

• uncontrollable body movements

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

• constipation

• drowsiness

• dry mouth

• headache

• nausea

What may interact with this medicine?

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

• deutetrabenazine

• tetrabenazine

This medicine may also interact with the following medications:

• alcohol

• certain medicines for fungal infections like ketoconazole and itraconazole

• certain medicines for seizures like carbamazepine, phenytoin

• clarithromycin

• digoxin

• fluoxetine

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• medicines for sleep

• paroxetine

• quinidine

• rifampin

• St. John's Wort

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.

Where should I keep my medicine?

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.

What should I tell my health care provider before I take this medicine?

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

• heart disease

• history of irregular heartbeat

• if you often drink alcohol

• liver disease

• Parkinson's disease

• an unusual or allergic reaction to valbenazine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. 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. Talk to your doctor or pharmacist before drinking alcoholic beverages.

This medicine may cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or 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.