Generic name: VALBENAZINE 40mg
Dosage form: capsule
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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
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)].
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- Drug class: VMAT2 inhibitors