Generic Name: valbenazine
Dosage Form: Capsules
Date of Approval: April 11, 2017
Company: Neurocrine Biosciences, Inc.
Treatment for: Tardive Dyskinesia
FDA Approves Ingrezza
The U.S. Food and Drug Administration (FDA) has approved Ingrezza (valbenazine), a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor for the treatment of adults with tardive dyskinesia (TD).
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is Ingrezza?
Ingrezza 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 this medicine is safe and effective in children.
Before taking Ingrezza
Before you start treatment, 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)
- are pregnant or plan to become pregnant. Ingrezza may harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Ingrezza passes into your breast milk. Do not breastfeed during treatment, and for 5 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during treatment.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Taking Ingrezza with certain other medicines may cause serious side effects. Do not start any new medicines without talking to your healthcare provider first.
How should I take Ingrezza?
- Take this medicine exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much to take and when to take it.
- Do not stop taking Ingrezza without talking to your healthcare provider first.
- The capsules can be taken with or without food.
- If you take too much or overdose, call your poison control center at 1-800-222-1222.
Ingrezza side effects
Ingrezza may cause serious side effects, including:
- Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how Ingrezza affects you.
- Heart rhythm problems (QT prolongation). Ingrezza may cause a heart problem known as QT prolongation. Symptoms of QT prolongation may include:
- fast, slow, or irregular heartbeat o 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.
The most common side effect is sleepiness (somnolence).
Other common side effects include:
- changes in balance (balance problems, dizziness) or an increased risk of falls
- dry mouth
- feelings of restlessness
- blurred vision
These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Ingrezza?
- Store the capsules at room temperature between 68°F to 77°F (20°C to 25°C).
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Ingrezza
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.
What are the ingredients in Ingrezza?
Active ingredient: valbenazine
Inactive ingredients: mannitol, partially pregelatinized starch, fumed silica, and magnesium stearate. The capsule shell contains gelatin, candurin silver fine, FD&C Red#40, and FD&C Blue#1.