2.1 Dosing and Administration Information

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.

Administer INGREZZA orally with or without food [see Clinical Pharmacology (12.3)].

2.2 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 [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.3 Dosage Recommendations for Known CYP2D6 Poor Metabolizers

The recommended dosage for known CYP2D6 poor metabolizers is INGREZZA 40 mg once daily [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.4 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inducers and Strong CYP3A4 or CYP2D6 Inhibitors

Coadministration with Strong CYP3A4 Inducers

Concomitant use of strong CYP3A4 inducers with INGREZZA is not recommended [see Drug Interactions (7.1)].

Coadministration with Strong CYP3A4 Inhibitors

The recommended dosage for patients receiving strong CYP3A4 inhibitors is INGREZZA 40 mg once daily [see Drug Interactions (7.1)].

Coadministration with Strong CYP2D6 Inhibitors

The recommended dosage for patients receiving strong CYP2D6 inhibitors is INGREZZA 40 mg once daily [see Drug Interactions (7.1)].