What to Know About Ingrezza (Valbenazine)

A Prescription Drug Used to Treat Tardive Dyskinesia

In This Article

Valbenazine, more commonly known as Ingrezza, is the first FDA-approved medication for tardive dyskinesia (TD), a serious side effect from long-term use of drugs that treat mental illness. Ingrezza is a vesicular monoamine transporter 2 (VMAT2) inhibitor that works by changing the activity of certain natural substances in the brain.

Ingrezza helps patients who are dealing with TD, which appears as repetitive, jerking movements in the face, neck, and tongue as a result of long-term use of antipsychotic medications. TD can also occur from taking medications used for treating nausea.

Ingrezza comes in a capsule form that you take once daily. To date, there is no generic version of Ingrezza available in the United States.

Uses

Valbenazine or Ingrezza was approved by the FDA in 2017 as a treatment for TD. The medication is prescribed to treat adults who experience movements in the face, tongue or other body parts that cannot be controlled.

While Ingrezza may help decrease the side effects of TD, it is not a cure for this condition.

Before Taking

Patients with a history of long-term antipsychotic medication for conditions such as schizophrenia, bipolar disorder, and major depression, and who are experiencing the side effects of TD, are good candidates for Ingrezza. If treatment with Ingrezza is successful, it allows patients to continue to take their antipsychotic medications, whereas, in the past, discontinuation or treatment with off-label medications was the only way to manage TD.

Precautions and Contraindications

To date, no controlled trials exist to establish the safety and efficacy of Ingrezza in children. That’s why the drug is prescribed for adults only and not approved for use by anyone under the age of 18 years old.

There is also a lack of information related to drug-association risks in pregnant or lactating women. Because of this, women should be cautioned about using Ingrezza while pregnant, and should always talk to their doctor about risks or discontinuing a prescription drug.

Additionally, if you are taking Ingrezza, breastfeeding is not recommended during the course of the medication and for five days after the final dose.

Since sleepiness is the most common side effect, patients should not perform activities requiring mental alertness, such as operating heavy machinery, until they know how they will be affected.

Tell your doctor if:

  • You have liver problems prior to taking Ingrezza. Patients with severe renal impairment should avoid taking Ingrezza.
  • You are allergic to valbenazine, or any other medications.
  • You are taking any other medications. Several medications may interact with Ingrezza, including monoamine oxidase inhibitors, deutetrabenazine, tetrabenazine, ketoconazole, itraconazole, carbamazepine, phenytoin, fluoxetine, paroxetine, quinidine, rifampin, and digoxin.

Other Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors

In addition to Ingrezza, Austedo (generic name: deutetrabenazine) is also sometimes prescribed for TD. It is mostly used to treat involuntary muscle movements caused by Huntington’s disease.

Dosage

Ingrezza is available in 40-mg and 80-mg capsules taken orally daily. According to the manufacturer, your doctor will prescribe an initial dose of 40-mg once daily for one week. After one week, you will increase to the recommended dose of 80-mg once daily. All listed dosages are according to the drug manufacturer. Check your prescription and talk to your doctor to make sure you are taking the right dose for you.

Modifications

According to the manufacturer, the following conditions require a modification of the dosage:

  • If you have severe hepatic impairment (decreased liver function), the recommended dose of Ingrezza is 40 mg once daily.
  • A reduced dose of 40 mg is also recommended if Ingrezza is taken alongside a strong CYP3A4 inhibitor, a class of drugs that can reduce your ability to metabolize certain medicines. Concomitant (simultaneous) use of Ingrezza with a drug in this class should be done with caution.
  • No dose adjustment is required for elderly patients.

How to Take and Store

  • Take with or without food.
  • If you miss a dose, take the missed dose as soon as you remember, but if it’s almost time for the next dose, skip the missed dose and continue your regular dosing schedule. 
  • Do not double up to make up for a missed dose.
  • Do not stop taking Ingrezza without talking to your doctor first.
  • If you take more than the recommended dose, call your poison control center at 1-800-222-1222.
  • When storing Ingrezza, keep the capsules in the original container and at room temperature away from heat and moisture. Ideal conditions are 20°C to 25°C (68°F to 77°F). Store out of reach of children and make sure the bottle is closed. Throw away any unused medicine after the expiration date.

Side Effects

Common side effects of Ingrezza include the following:

  • Sleepiness (this is the most common side effect)
  • Headache
  • Dizziness, change in balance that can result in trouble walking or falls
  • Dry mouth
  • Constipation
  • Blurred vision

More severe side effects can include:

  • Heart rhythm problems 
  • Allergic reaction resulting in hives, difficulty breathing, swelling of the face, lips, or mouth
  • Shortness of breath
  • Fainting or loss of consciousness

If you experience any of these symptoms, call your doctor immediately, or seek emergency care right away.

Ingrezza may cause other side effects. If you experience anything not on this list, make note of it, and talk with your doctor.

Warnings and Interactions

Several prescription medications cause complications when taken with Ingrezza. The following drugs have clinically important interactions with Ingrezza:

  • Monoamine Oxidase Inhibitors (MAOIs): Taking Ingrezza and MAOIs such as isocarboxazid, phenelzine, selegiline at the same time is not recommended. 
  • Strong CYP3A4 Inhibitors: Taking a strong CYP3A4 such as itraconazole, ketoconazole, or clarithromycin with the full dose of Ingrezza is contraindicated. The current guidelines recommend reducing Ingrezza dose if taken at the same time as a strong CYP3A4 inhibitor.
  • Strong CYP2D6 Inhibitors: Taking a strong CYP2D6 inhibitor such as paroxetine, fluoxetine, quinidine with the full dose of Ingrezza is contraindicated. The current guidelines recommend reducing Ingrezza dose based on tolerability if taken at the same time as a strong CYP2D6 inhibitor.
  • Strong CYP3A4 Inducers: Taking a strong CYP3A4 inducer such as rifampin, carbamazepine, phenytoin, or St. John’s wort with the full dose of Ingrezza is contraindicated. The current guidelines do not recommend taking these together.
  • Digoxin: Adjust dosage of digoxin if needed. 
  • Grapefruit products such as grapefruit juice may worsen the side effects of Ingrezza. Feeling sleepy or experiencing an irregular heart rhythm can happen if you regularly consume grapefruit products. Talk to your doctor about any side effects you may experience.
  • Ingrezza may impair your thinking or reaction time. That’s why it’s recommended to avoid drinking alcohol until you know how your body reacts to the dose. Additionally, operating hazardous equipment should also be paused until you know how Ingrezza will affect you.
  • Do not stop this medication on your own. Talk with your doctor about how to gradually come off of Ingrezza. 

To report suspected adverse reactions, you may contact AbbVie Inc.at 1-800-633-9110 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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