valbenazine 80 mg capsule

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Medication name

Generic name:
Valbenazine - oral

Pronunciation
(val-BEN-a-zeen)

Brand name(s)
Ingrezza

Warning

If you have Huntington's disease, valbenazine can sometimes increase the risk of depression and suicidal thoughts/attempts. People with Huntington's disease are already more likely to have depression and suicidal thoughts/attempts. Talk with your doctor about the risks and benefits of this medication. Tell your doctor right away if you or your family/caregivers notice that you have new/worsening symptoms of depression, sadness, loss of interest in activities you used to enjoy, suicidal thoughts/attempts, or other mental/mood/behavior changes (such as new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings).

Uses

Valbenazine is used to treat involuntary movements of the face, tongue, or other body parts (tardive dyskinesia). This medication is also used to decrease the involuntary movements (chorea) caused by Huntington's disease. Reducing involuntary movements will help you take part in more of your normal daily activities. 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 to use

Read the Patient Information Leaflet if available from your pharmacist before you start using valbenazine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

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.

Side effects

See also Warning section.

Drowsiness, dizziness, restlessness, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Sometimes valbenazine can cause side effects that are similar to the symptoms of worsening Huntington's disease. Your doctor may need to adjust your dose to see if these side effects are due to the drug or to the disease. Tell your doctor right away if any of these serious side effects occur:

  • shaking/tremors
  • slowed movement
  • loss of balance
  • trouble swallowing

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms:

  • fever
  • muscle stiffness/pain/tenderness/weakness
  • severe tiredness
  • severe confusion
  • sweating
  • fast/irregular heartbeat
  • dark urine
  • signs of kidney problems (such as change in the amount of urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking valbenazine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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 (cannabis) 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 (cannabis).

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 (see above).

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. Breastfeeding is not recommended while using this drug and for 5 days after the last dose. Consult your doctor before breastfeeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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, metaxalone, 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.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised November 2023.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.