Valbenazine

Pronunciation: val-BEN-a-zeen
Generic name: Valbenazine
Brand names: Ingrezza, Ingrezza Sprinkle
Dosage form: capsule (40 mg, 60 mg, 80 mg), sprinkle capsules (40 mg, 60 mg, 80 mg)
Drug class: VMAT2 inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 3, 2024.

What is valbenazine?

Valbenazine (Ingrezza) is used to treat tardive dyskinesia and chorea associated with Huntington's disease (HD), which are both body movement disorders. Valbenazine works by decreasing the amount of dopamine, in the nerve endings in the brain, which helps control body movements. Ingrezza is from a class of medicines called VMAT2 inhibitors, as it inhibits the vesicular monoamine transporter 2 (VMAT2) in neurons. Valbenazine controls the symptoms of movement disorders but does not cure the conditions.

Tardive dyskinesia is a nervous system disorder that causes repetitive, uncontrolled muscle movements, usually in the face (chewing, lip smacking, frowning, tongue movement, blinking, or eye movement). Tardive dyskinesia is often caused by long-term treatment with certain psychiatric medications. Chorea is a movement disorder that results in sudden involuntary movements. It can be caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain).

Valbenazine (Ingrezza Brand) became an FDA-approved medicine on April 11, 2017, for adults with tardive dyskinesia, and on August 18, 2023, and it became approved for the treatment of chorea associated with Huntington's disease. The chorea associated with Huntington's disease approval was based on positive results from the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 that showed an improvement in chorea severity with a statistically significant greater improvement in Total Maximal Chorea (TMC) score when compared to placebo.

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 side effects

Common valbenazine side effects

• headache, dizziness, drowsiness;
• problems with balance or coordination;
• dry mouth;
• feeling restless;
• constipation; or
• blurred vision.

Serious valbenazine side effects

Also, see Warnings section below.

Get emergency medical help if you have signs of an allergic reaction to this medicine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• extreme drowsiness;
• fast, slow, or uneven heartbeats;
• pounding heartbeats or fluttering in your chest;
• shortness of breath; or
• a light-headed feeling, like you might pass out; or
• Parkinson-like symptoms - tremors, shaking, stiffness, problems with balance or walking.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Valbenazine can cause:

Depression and suicidal ideation and behavior are observed in patients with Huntington’s disease.

Hypersensitivity, including angioedema, may occur. Treatment should be discontinued if this occurs.

Somnolence and sedation may impair the patient’s ability to drive or operate hazardous machinery.

QT Prolongation: There may be an increase in QT interval. Usage should be avoided in patients with congenital long QT syndrome or arrhythmias associated with prolonged QT interval.

Neuroleptic Malignant Syndrome (NMS) may occur. Treatment should be discontinued if this syndrome is observed.

Parkinsonism: Some patients have reported Parkinson-like symptoms, including severe cases, during the postmarketing period. The dose of this medicine

Before taking this medicine

You should not use this medicine if you are allergic to valbenazine or any ingredients contained in this medicine.

To make sure valbenazine is safe for you, tell your doctor if you have ever had:

• heart disease;

• long QT syndrome or other heart rhythm disorder;

• congestive heart failure;

• a heart attack;

• liver disease; or

• kidney disease.

Pregnancy

Valbenazine may cause fetal harm. Tell your doctor if you are pregnant, become pregnant, or plan to become pregnant.

Breastfeeding

Do not breastfeed while using valbenazine and for at least 5 days after your last dose.

How should I take valbenazine?

The usual dose of valbenazine is once a day, with or without food.

Valbenazine capsules are swallowed whole with a glass of water.

Valbenazine Sprinkle capsules may be opened and sprinkled over soft food (do not use milk or drinking water) and may be swallowed whole with water. Do not crush or chew.

Do not stop taking this medicine without first asking your doctor.

Take this medicine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Valbenazine Dosing information

Usual Adult Valbenazine Dose for Tardive Dyskinesia:

Initial Dose: 40 mg orally once a day

Maintenance Dose: Increase to 80 mg orally once a day after one week at the initial dose; however, a continuation of the initial dose may be considered for some patients.

Usual Adult Valbenazine Dose for Chorea associated with Huntington’s disease:

Initial dose: 40 mg once daily.

Maintenance Dose: Increase the dose in 20 mg increments every two weeks to the recommended dosage of 80 mg once daily.

Comments:

• Administer 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.

Ingrezza capsules are available as 40 mg, 60 mg, and 80 mg.

Ingrezza Sprinkle Capsules are available as 40 mg, 60 mg, and 80 mg.

Related/similar drugs

Austedo, amantadine, pyridoxine, vitamin e, Ingrezza, tetrabenazine, valbenazine, deutetrabenazine

What other drugs will affect valbenazine?

Other drugs may interact with valbenazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

It is important to tell your doctor if you take any of these medicines.

• Monoamine oxidase inhibitors (MAOIs).

• Strong CYP3A4 inducers

• Strong CYP3A4 inhibitors

• Strong CYP2D6 inhibitors

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Valbenazine may impair your thinking or reactions. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Ingredients

Active ingredient: valbenazine

Ingrezza inactive ingredients: 40 mg capsule, 60 mg capsule, 80 mg capsule: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin.

Ingrezza Sprinkle inactive ingredients 40 mg, 60 mg, 80 mg capsule: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. The hard gelatin capsule shells contain gelatin and candurin silver fine.

Storage

Store at 59°F to 86°F (15°C to 30°C).

Company

Ingrezza Distributed by: Neurocrine Biosciences, Inc., San Diego, CA 92130, U.S.A.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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