Valbenazine

What is Valbenazine?

• Valbenazine (INGREZZA) is a vesicular monoamine transporter 2 (VMAT2) inhibitor used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

What are the uses of this medicine?

• This medicine used for the treatment of adults with tardive dyskinesia.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of hypersensitivity to valbenazine or any components of INGREZZA.

What drug interactions can this medicine cause?

• Avoid concomitant use of INGREZZA with MAOIs (eg: isocarboxazid, phenelzine, selegiline).
• Reduce INGREZZA dose when INGREZZA is coadministered with a strong CYP3A4 inhibitor (eg: itraconazole, ketoconazole, clarithromycin).
• Reduce INGREZZA dose when INGREZZA is coadministered with a strong CYP2D6 inhibitor (eg: paroxetine, fluoxetine, quinidine).
• Concomitant use of strong CYP3A4 inducers(eg: rifampin, carbamazepine, phenytoin, St. John’s wort) with INGREZZA is not recommended.
• Concomitant use of INGREZZA with digoxin increased digoxin levels.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosageː

• The initial dosage for INGREZZA is 40 mg once daily.
• After one week, increase the dose to the recommended dosage of 80 mg once daily.
• A dosage of 40 mg or 60 mg once daily may be considered depending on response and tolerability.

Dosage Recommendations for Patients with Hepatic Impairment:

• The recommended dosage for patients with moderate or severe hepatic impairment (Child-Pugh score 7 to 15) is INGREZZA 40 mg once daily.

• The recommended dosage for known CYP2D6 poor metabolizers is 40 mg once daily.

Administration

• Take INGREZZA exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much INGREZZA to take and when to take it.
• Do not stop taking INGREZZA without talking to your healthcare provider first.
• INGREZZA can be taken with or without food.
• If you take too much INGREZZA, call your poison control center at 1-800-222-1222.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 40 mg, 60 mg and 80 mg.

This medicine is available in fallowing brand namesː

• INGREZZA

What side effects can this medication cause?

The most common side effects of this medicine include:

• somnolence
• changes in balance (balance problems, dizziness) or an increased risk of falls
• headache
• feelings of restlessness
• dry mouth
• constipation
• blurred vision

INGREZZA may cause serious side effects, including:

• Sleepiness (somnolence)
• Heart rhythm problems (QT prolongation)
• Parkinson-like symptoms

What special precautions should I follow?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you.
• INGREZZA may cause an increase in QT interval. Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval.
• INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.

What to do in case of emergency/overdose?

Management for overdosage:

• No specific antidotes for INGREZZA are known.
• In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement.
• If an overdose occurs, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org).

Can this medicine be used in pregnancy?

• The limited available data on INGREZZA use in pregnant women are insufficient to inform a drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness of INGREZZA have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient: valbenazine Inactive ingredients: 40 mg capsule, 60 mg capsule, 80 mg capsule: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose.

Who manufactures and distributes this medicine?

• Packager: Neurocrine Biosciences, Inc.

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Valbenazine
• FDA Valbenazine