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Important Information
INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.
IMPORTANT SAFETY INFORMATION
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >Placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see INGREZZA full Prescribing Information
Actor portrayals of tardive dyskinesia movements were completed in the presence of a movement disorder neurologist who assessed each movement for severity from 0 (no dyskinesia) to 4 (severe dyskinesia) using Items 1 through 7 of the Abnormal Involuntary Movement Scale (AIMS).
Subscores for baseline video
AIMS Items 1-4: Facial and oral movements | Baseline | Week 6 | Week 48 |
---|---|---|---|
1. Muscles of facial expression | 3 | 1 | 0 |
2. Lips and perioral area | 2 | 2 | 2 |
3. Jaw | 2 | 2 | 2 |
4. Tongue | 0 | 0 | 0 |
AIMS Items 5-6: Extremity movements | |||
5. Upper (arms, wrists, hands, fingers) | 2 | 2 | 2 |
6. Lower (legs, knees, ankles, toes) | 0 | 0 | 0 |
AIMS Item 7: Trunk movements | |||
7. Neck, shoulders, hips | 1 | 0 | 0 |
Total AIMS scores portrayed in video | 10 | 7 | 6 |