Ingrezza

INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia [see Clinical Studies ( 14.1 )] . - chorea associated with Huntington’s disease [see Clinical Studies ( 14.2 )] . INGREZZA and INGREZZA SPRINKLE are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated for the treatment of adults with: - tardive dyskinesia. ( 1 ) - chorea associated with Huntington’s disease.

( 1 )

INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported with use of INGREZZA [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )]. Known hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.

( 4 )

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 )

5.1 Depression and Suicidal Ideation and Behavior in Patients with Huntington’s Disease Patients with Huntington’s disease are at increased risk for depression, and suicidal ideation or behaviors. VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk for suicidal ideation and behaviors in patients with Huntington’s disease. In a 14-week, double-blind, placebo-controlled trial [see Clinical Studies ( 14.2 )] , depression or depressed mood was reported in 4.7% of patients taking INGREZZA compared to 1.6% of patients who received placebo, and no patients taking INGREZZA reported suicidal ideation or behavior compared to 1 patient (1.6%) who received placebo.