Valbenazine

Generic name: Valbenazine
Brand name: Ingrezza
Dosage form: oral capsule
Drug class: VMAT2 inhibitors

Medically reviewed by  A Ras MD.

What is valbenazine used for?

Valbenazine is a prescription medicine that is used to treat tardive dyskinesia.

Description

INGREZZA contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure:

The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57.

INGREZZA capsules are intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: 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.

Mechanism of Action

The mechanism of action of valbenazine in the treatment of tardive dyskinesia is unclear, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.

Before taking valbenazine, tell your doctor:

• If you are allergic to valbenazine; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had a long QT on ECG or other heartbeat that is not normal.
• If you have kidney problems.
• If you are taking certain drugs used for depression like isocarboxazid, phenelzine, or tranylcypromine, or drugs used for Parkinson’s disease like selegiline or rasagiline.
• If you are taking any of these drugs: Carbamazepine, phenytoin, rifampin, or St. John’s wort.
• If you are breast-feeding. Do not breast-feed while you take valbenazine and for 5 days after your last dose.

This is not a list of all drugs or health problems that interact with valbenazine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take valbenazine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take valbenazine?

• Tell all of your health care providers that you take valbenazine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how valbenazine affects you.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using valbenazine while you are pregnant.

How is valbenazine best taken?

Use valbenazine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking valbenazine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of valbenazine that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Shakiness, trouble moving around, or stiffness.
• Drooling.
• Not able to focus.
• Blurred eyesight.
• Trouble passing urine.
• Slow heartbeat.
• Shortness of breath.
• Dizziness.
• A type of abnormal heartbeat (prolonged QT interval) can happen with valbenazine. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

What are some other side effects of valbenazine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling tired or weak.
• Dry mouth.
• Headache.
• Constipation.
• Restlessness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out valbenazine?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.