Valbenazine (val-BEN-a-zeen)

Treats tardive dyskinesia (a movement disorder) and chorea caused by Huntington disease.

Brand Name(s):

Ingrezza, Ingrezza Initiation Pack, Ingrezza Sprinkle

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Ingrezza®:
  • You may swallow the capsule whole with water.
• Ingrezza® Sprinkle:
  • You may swallow the capsule whole with water. Do not give this medicine through a feeding tube. Do not sprinkle the contents of the capsule into milk or water.
  • Place 1 tablespoon of soft food (including applesauce, yogurt, or pudding) into a small cup of bowl. Hold the capsule carefully over the soft food. Gently pull the capsule apart and sprinkle the contents onto the soft food.
  • Check the capsule to make sure you did not miss any granules. Tap the capsule to remove any remaining granules.
  • Stir the granules into the soft food and swallow the mixture right away. Do not crush the granules while stirring them. Do not chew the granules. Drink a glass of water (8 ounces or 240 milliliters) after taking the mixture.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. You may store the mixture for up to 2 hours at room temperature. Throw way unused mixture after 2 hours.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine and an MAO inhibitor (MAOI) within 14 days of each other.
• Some medicines can affect how valbenazine works. Tell your doctor if you are using digoxin, ketoconazole, midazolam, paroxetine, or rifampin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, heart rhythm problems (including QT prolongation), or mental problems (including depression, nervousness, anxiety, suicidal thoughts, psychosis).
• Do not breastfeed while you are using this medicine and for 5 days after the last dose.
• This medicine may cause the following problems:
  • Increased risk for depression or changes in mood or behavior in patients with Huntington disease
  • Heart rhythm problems, including QT prolongation
  • Neuroleptic malignant syndrome (a nerve disorder that could be life-threatening)
  • Parkinsonism (a movement disorder)
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fainting, dizziness, lightheadedness
• Fast, slow, or uneven heartbeat
• Problems with balance or walking, stiffness, shaking
• Trouble breathing, swallowing, or speaking
• Trouble sitting still, feeling restless, nervous, or irritable
• Unusual changes in mood or behavior, thoughts of hurting yourself or others

If you notice these less serious side effects, talk with your doctor:

• Dry mouth, constipation, headache, confusion, blurred vision, decrease in how much or how often you urinate
• Joint pain
• Nausea, vomiting
• Sleepiness, unusual drowsiness, or tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088