Generic Name: Valbenazine Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Valbenazine used for?

Valbenazine is used to treat involuntary movements of the face, tongue, or other body parts (tardive dyskinesia). This medication is thought to work by decreasing the amount of certain natural substances in the brain that affect how your nerves and muscles work (monoamines such as dopamine, serotonin, and norepinephrine).

How should I take Valbenazine?

Take this medication by mouth with or without food as directed by your doctor, usually once daily. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse.

How do I store Valbenazine?

Valbenazine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Valbenazine in the bathroom or the freezer. There may be different brands of Valbenazine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Valbenazine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Valbenazine?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Valbenazine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using valbenazine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using valbenazine safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Breast-feeding while using this drug and for 5 days after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Valbenazine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Valbenazine. Valbenazine is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Valbenazine?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Valbenazine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using valbenazine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using valbenazine safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Breast-feeding while using this drug and for 5 days after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Valbenazine?

Some products that may interact with this drug are: deutetrabenazine, tetrabenazine.

Other medications can affect the removal of valbenazine from your body, which may affect how valbenazine works. Examples include rifamycins (such as rifabutin, rifampin), drugs used to treat seizures (such as carbamazepine, phenytoin), St. John’s wort, among others.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Ask your doctor when to start or stop taking this medication.

Valbenazine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Valbenazine?

Valbenazine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Valbenazine?

Valbenazine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Valbenazine.

What is the dose of Valbenazine for an adult?

Usual Adult 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, continuation of the initial dose may be considered for some patients.

Comments: Administer with or without food.

Use: Treatment of tardive dyskinesia.

Renal Dose Adjustments

-Mild to Moderate Renal Impairment (CrCl 30 to 90 mL/min): No adjustment recommended.

-Severe Renal Impairment (CrCl less than 30 mL/min): Not recommended.

Liver Dose Adjustments

-Moderate to Severe Hepatic Impairment (Child-Pugh score 7 to 15): 40 mg orally once a day.

Dose Adjustments

CYP450 2D6 POOR METABOLIZERS: Consider reducing the dose based on tolerability.

CONCOMITANT USE WITH MONOAMINE OXIDASE INHIBITORS (MAOIs): Avoid concomitant use.

CONCOMITANT USE WITH STRONG CYP450 INDUCERS/INHIBITORS:

-CYP450 3A4 Inducers: Not recommended.

-CYP450 3A4 Inhibitors: 40 mg orally once a day.

-CYP450 2D6 Inhibitors: Consider reducing the dose based on tolerability.

What is the dose of Valbenazine for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Valbenazine available?

Valbenazine is available in the following dosage forms and strengths:

  • Oral capsule.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Valbenazine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 9, 2018 | Last Modified: August 9, 2018

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