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INGREZZA and INGREZZA SPRINKLE are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated for the treatment of adults with:
DOSAGE AND ADMINISTRATION
Tardive dyskinesia: The initial dosage is 40 mg once daily. After one week, increase the dose to the recommended dosage of 80 mg once daily. (2.1)
Chorea associated with Huntington’s disease: The initial dosage is 40 mg once daily. Increase the dose in 20 mg increments every two weeks to the recommended dosage of 80 mg once daily. (2.1)
40 mg or 60 mg once daily may be considered depending on response and tolerability. (2.1)
Can be taken with or without food. (2.2)
INGREZZA SPRINKLE may be opened and sprinkled over soft food (do not use milk or drinking water). INGREZZA SPRINKLE may be swallowed whole with water. Do not crush or chew. (2.2)
The recommended dosage for patients with moderate or severe hepatic impairment is 40 mg once daily. (2.3)
The recommended dosage for known CYP2D6 poor metabolizers is 40 mg once daily. (2.4)
DOSAGE FORMS AND STRENGTHS
INGREZZA capsules: 40 mg, 60 mg, and 80 mg. (3)
INGREZZA SPRINKLE capsules: 40 mg, 60 mg, and 80 mg. (3)
Most common adverse reactions (≥5% and twice the rate of placebo):
Known hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE. (4)
WARNINGS AND PRECAUTIONS:
Depression and suicidal ideation and behavior in patients with Huntington’s disease. (5.1)
Hypersensitivity, including angioedema may occur. Discontinue if this occurs. (5.2)
Somnolence/sedation: May impair patient’s ability to drive or operate hazardous machinery. (5.3)
QT Prolongation: 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. (5.4)
Neuroleptic Malignant Syndrome (NMS): Discontinue if this occurs. (5.5)
Parkinsonism: Cases of parkinson-like symptoms, some of which were severe, have been reported in the postmarketing period. Reduce the dose or discontinue INGREZZA or INGREZZA SPRINKLE treatment in patients who develop clinically significant parkinson-like signs or symptoms. (5.6)
Dose adjustments due to drug interactions (2.5, 7.1):
Human Experience
The pre-marketing clinical trials involving INGREZZA in approximately 850 subjects do not provide information regarding symptoms with overdose.
Management of Overdosage
No specific antidotes for INGREZZA or INGREZZA SPRINKLE are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
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