Ingrezza Dosage

2.1 Dosing and Administration Information

The initial dose for INGREZZA is 40 mg once daily. After one week, increase the dose to the recommended dose of 80 mg once daily. Continuation of 40 mg once daily may be considered for some patients.

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

2.2 Dosage Recommendations for Patients with Hepatic Impairment

The recommended dose 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

Consider reducing INGREZZA dose based on tolerability for known CYP2D6 poor metabolizers [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

Reduce INGREZZA dose to 40 mg once daily when INGREZZA is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1)].

Coadministration with Strong CYP2D6 Inhibitors

Consider reducing INGREZZA dose based on tolerability when INGREZZA is coadministered with a strong CYP2D6 inhibitor [see Drug Interactions (7.1)].