Question 1

What is Valbenazine?

Accepted Answer

Valbenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor. It functions by altering the activity of specific natural chemicals in the brain that help regulate muscle control.

By modulating these neurotransmitters, the medication assists in managing involuntary physical movements. This process helps to regulate the chemical signals that are involved in muscle activity.

Question 2

What is Valbenazine used for?

Accepted Answer

Valbenazine is used to treat tardive dyskinesia .

Question 3

How does Valbenazine work?

Accepted Answer

Mechanism of Action

Valbenazine belongs to a class of drugs called vesicular monoamine transporter 2 (VMAT2) inhibitors. It is used to treat movement disorders characterized by uncontrollable body movements, such as tardive dyskinesia.

While the exact way valbenazine works is not completely understood, it is believed to function by:

Targeting VMAT2: The drug blocks a specific protein in the brain called VMAT2. This protein is responsible for transporting and storing chemical messengers, such as dopamine, within nerve cells.

Regulating Dopamine: By inhibiting this protein, valbenazine reduces the amount of dopamine available for release in the parts of the brain that control muscle movement.

Reducing Involuntary Movements: Lowering the levels of these chemicals helps calm the overactive nerve signals that cause jerky, repetitive, or uncontrollable muscle movements.

Question 4

What are the brand names for Valbenazine?

Accepted Answer

Valbenazine is sold under the brand name Ingrezza .

Question 5

What are the active ingredients in Valbenazine?

Accepted Answer

The active ingredient in Valbenazine is valbenazine .

Question 6

What are the side effects of Valbenazine?

Accepted Answer

Common side effects of Valbenazine may include:

Sleepiness

Fatigue

Dry mouth

Always consult with a healthcare professional about potential side effects.

Question 7

What drug class is Valbenazine?

Accepted Answer

Valbenazine belongs to the vesicular monoamine transporter 2 (VMAT2) inhibitor drug class.

Question 8

What is the dosage of Valbenazine and how do I take it?

Accepted Answer

How to Take Valbenazine

Valbenazine is available as capsules that are taken by mouth. It is generally prescribed to be taken once a day. You may take this medication with or without food.

Administration Instructions

Standard Capsules: Swallow the capsules whole. Do not crush, chew, or break the capsules.

Sprinkle Capsules: If you have difficulty swallowing, certain formulations are designed to be opened. The contents can be sprinkled onto a small amount of soft food, such as applesauce or yogurt. Consume the mixture immediately without chewing the granules.

It is helpful to take your dose at the same time each day to help you remember and to keep a steady amount of the medicine in your system.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take two doses at once or take extra medicine to make up for a missed dose.

Question 9

Is Valbenazine safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

The effects of valbenazine on human pregnancy are not well-studied. Animal studies have shown that high doses of the medication may lead to issues such as reduced fetal weight or an increase in stillbirths. Because there is no adequate data on use in pregnant women, it is important to discuss the potential risks and benefits with a healthcare provider if you are pregnant or planning to become pregnant.

Breastfeeding

It is not known if valbenazine passes into human breast milk. However, due to the potential for serious adverse reactions in a nursing infant, breastfeeding is not recommended while taking this medication and for at least 5 days after the final dose. Patients should consult with their doctor to determine the best way to feed their baby while undergoing treatment.

Question 10

What forms and strengths does Valbenazine come in?

Accepted Answer

Valbenazine is provided as an oral medication in the following formats:

Capsules: Standard capsules designed to be swallowed whole.

Sprinkle capsules: A specialized capsule form that can be swallowed whole or opened to have the contents mixed with soft food for individuals who have difficulty swallowing.

Question 11

What is the FDA approval status of Valbenazine?

Accepted Answer

FDA Approval and Indications

Valbenazine was first approved by the U.S. Food and Drug Administration (FDA) in April 2017. It is indicated for the treatment of adults with tardive dyskinesia, a movement disorder characterized by involuntary movements often caused by long-term use of antipsychotic medications. In August 2023, the FDA expanded its approval to include the treatment of chorea (involuntary, irregular movements) associated with Huntington’s disease.

Boxed Warning

The FDA has issued a boxed warning for valbenazine when used to treat chorea associated with Huntington’s disease. This warning states that the medication can increase the risk of depression and suicidal thoughts or behavior in these patients. Healthcare providers are advised to balance the risks of depression and suicide with the clinical need for chorea treatment. Patients should be closely monitored for new or worsening depression, suicidal ideation, or unusual changes in behavior.

Pharmacogenomic Considerations

The FDA-approved labeling includes specific guidance for patients based on their genetic metabolism. Individuals identified as CYP2D6 poor metabolizers may require a reduced dosage. Because these patients process the drug more slowly, they are at a higher risk for increased drug exposure and associated side effects, such as heart rhythm changes (QT prolongation).

Regulatory Status

Prescription Requirement: Valbenazine is available only by prescription from a licensed healthcare provider.

Controlled Substance Status: It is not classified as a controlled substance.

Contraindications: It is contraindicated in patients with Huntington’s disease who have untreated or inadequately treated depression or who are actively suicidal.

Question 12

What should I know about Valbenazine and cost?

Accepted Answer

Brand and Generic Availability

Valbenazine is currently available only as the brand-name medication Ingrezza. There is no generic version available at this time. Brand-name drugs typically cost more than their generic counterparts because they are protected by patents that prevent other companies from making the same medication.

Insurance Coverage

Most insurance plans, including Medicare and Medicaid, cover valbenazine, but the out-of-pocket cost depends on your specific plan's formulary. Many insurance providers require prior authorization before they will approve coverage for this medication. This process involves your healthcare provider submitting documentation to prove the medical necessity of the drug.

Specialty Pharmacy Requirements

Valbenazine is usually dispensed through specialty pharmacies rather than standard retail pharmacies. Specialty pharmacies handle medications that are high-cost or require special handling. These pharmacies often provide additional services, such as help with insurance navigation and financial assistance applications.

Financial Assistance Programs

Because the list price for valbenazine can be high, several options may help reduce the cost:

Copay Savings Cards: The manufacturer may offer savings cards for patients with commercial insurance that can significantly lower monthly copayments.

Patient Assistance Programs: For individuals who are uninsured or underinsured, the manufacturer or independent non-profit organizations may offer programs that provide the medication at a reduced cost or for free, based on financial need.

Support Services: Dedicated support programs can help patients identify which financial resources they are eligible for and assist with the application process.

Valbenazine

Medication Quick Facts

📋Overview

What It's Used For

How It Works

Brand Names

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

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