FDA approved Ingrezza (valbenazine) for Tardive Dyskinesia and Huntington's Disease ChoreaFDA approved Ingrezza for Two Movement Disorders

Ingrezza (valbenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor. The precise mechanism by which valbenazine exerts its effect in tardive dyskinesia and chorea associated with Huntington's disease is unknown, but it is thought to involve inhibition of VMAT2, leading to decreased monoamine uptake into synaptic vesicles.

Ingrezza and Ingrezza Sprinkle are indicated for the treatment of adults with: - tardive dyskinesia - chorea associated with Huntington's disease

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. A dosage of 40 mg or 60 mg once daily may be considered depending on response and tolerability.

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. A dosage of 40 mg or 60 mg once daily may be considered depending on response and tolerability.

Ingrezza can be taken with or without food. 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.

The recommended dosage for patients with moderate or severe hepatic impairment (Child-Pugh score 7 to 15) is 40 mg once daily. The recommended dosage for known CYP2D6 poor metabolizers is 40 mg once daily. The recommended dosage for patients receiving strong CYP3A4 inhibitors or strong CYP2D6 inhibitors is 40 mg once daily. Concomitant use with strong CYP3A4 inducers is not recommended.

The effectiveness of Ingrezza for tardive dyskinesia was established in a randomized, double-blind, placebo-controlled trial in patients with moderate to severe tardive dyskinesia. Patients had underlying schizophrenia, schizoaffective disorder, or a mood disorder. The primary efficacy measure was the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (sum of items 1 to 7; range 0 to 28, with higher scores indicating greater severity). A decrease in score indicates improvement. The AIMS was scored by central raters blinded to treatment assignment. The trial demonstrated a reduction in AIMS scores for Ingrezza compared to placebo. The effectiveness of Ingrezza Sprinkle is based on the adequate and well-controlled studies of Ingrezza. For chorea associated with Huntington's disease, the effectiveness of Ingrezza is based on a separate clinical trial; trial data not available in label.

Not reported in label.

Ingrezza is a VMAT2 inhibitor approved for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease. It offers an oral treatment option for these conditions. Dosing should be individualized based on response and tolerability, with lower doses recommended for patients with moderate or severe hepatic impairment, known CYP2D6 poor metabolizers, and those receiving strong CYP3A4 or CYP2D6 inhibitors.