Schizophrenia: The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg per day to 160 mg per day. The maximum recommended dose is 160 mg per day (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Administration Instructions: LATUDA should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold. In the clinical studies, LATUDA was administered with food (see Pharmacology: Pharmacokinetics under Actions).
Dose Modifications in Special Populations: Renal Impairment: As the 20 mg tablet is not available in Hong Kong, it is not recommended that Latuda be used in patients with moderate (creatinine clearance: 30 to <50 mL/min) or severe renal impairment (creatinine clearance <30 mL/min). (See Use in Specific Populations under Precautions.)
Hepatic Impairment: As the 20 mg tablet is not available in Hong Kong, it is not recommended that LATUDA be used in patients with moderate (Child-Pugh Score = 7 to 9) or severe hepatic impairment (Child-Pugh Score = 10 to 15). (See Use in Specific Populations under Precautions.)
Dose Modifications Due to Drug Interactions: Concomitant Use with CYP3A4 Inhibitors: LATUDA should not be used concomitantly a strong CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) (see Contraindications).
If LATUDA is being prescribed and a moderate CYP3A4 inhibitor (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil, etc.) is added to the therapy, the LATUDA dose should be reduced to half of the original dose level. As the 20 mg tablet is not available in Hong Kong, it is not recommended that LATUDA be continued if the original dose is 40 mg. Similarly, as the 20 mg tablet is not available in Hong Kong, if a moderate CYP3A4 inhibitor is being prescribed it is not recommended that LATUDA be added to therapy. If a moderate CYP3A4 inhibitor is prescribed with LATUDA, the maximum recommended dose of LATUDA is 80 mg/day (see Contraindications and Interactions).
Grapefruit and grapefruit juice should be avoided in patients taking LATUDA, since these may inhibit CYP3A4 and alter LATUDA concentrations (see Interactions).
Concomitant Use with CYP3A4 Inducers: LATUDA should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.) (see Contraindications). If LATUDA is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the LATUDA dose after chronic treatment (7 days or more) with the CYP3A4 inducer.