Dosing Information

The recommended dosage of NOURIANZ is 20 mg administered orally once daily. The dosage may be increased to a maximum of 40 mg once daily, based on individual need and tolerability. Initial dose titration is not required.

NOURIANZ can be taken with or without food [see Clinical Pharmacology (12.3)].

Dosage Adjustment with Strong CYP 3A4 Inhibitors

The maximum recommended dosage of NOURIANZ with concomitant use of strong CYP3A4 inhibitors is 20 mg once daily [see Drug Interactions (7.1)].

Dosing with Strong CYP 3A4 Inducers

Avoid use of NOURIANZ with strong CYP3A4 inducers [see Drug Interactions (7.1)].

Dosage Adjustment in Patients with Hepatic Impairment

The maximum recommended dosage of NOURIANZ in patients with moderate hepatic impairment (Child-Pugh B) is 20 mg once daily. Closely monitor patients with moderate hepatic impairment for adverse reactions when on NOURIANZ treatment [see Adverse Reactions (6.1)]. Avoid use of NOURIANZ in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7)].

Dosage Adjustment for Tobacco Smokers

The recommended dosage of NOURIANZ in patients who use tobacco in amounts of 20 or more cigarettes per day (or the equivalent of another tobacco product) is 40 mg once daily [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].