Valbenazine
What is Valbenazine?[edit | edit source]
- 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?[edit | edit source]
- This medicine used for the treatment of adults with tardive dyskinesia.
How does this medicine work?[edit | edit source]
- 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 ?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- It was approved for use in the United States in 2017.
How should this medicine be used?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- Safety and effectiveness of INGREZZA have not been established in pediatric patients.
What are the active and inactive ingredients in this medicine?[edit | edit source]
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?[edit | edit source]
- Packager: Neurocrine Biosciences, Inc.
What should I know about storage and disposal of this medication?[edit | edit source]
- 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).
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