Clozapine

Dosage Recommendations in Patients with Renal or Hepatic Impairment, or CYP2D6 Poor Metabolizers It may be necessary to reduce the VERSACLOZ dosage in patients with significant renal impairment or hepatic impairment, or in CYP2D6 poor metabolizers [see Use in Specific Populations (8.6, 8.7)] .

Patients with Renal or Hepatic Impairment Dose reduction may be necessary in patients with significant impairment of renal or hepatic function. Clozapine concentrations may be increased in these patients, because clozapine is almost completely metabolized and then excreted [see Dosage and Administration , Clinical Pharmacology ].

Important Administration Instructions Educate patients and caregivers on how to administer VERSACLOZ ( see the Instructions for Use ). VERSACLOZ can be taken with or without food [ see Clinical Pharmacology ]. The following are important administration instructions: Administer VERSACLOZ orally using the provided oral syringes (1 mL or 9 mL).

After shaking the VERSACLOZ bottle for 10 seconds, press the syringe adaptor on top of the bottle. Insert the oral syringe (1 mL or 9 mL) filled with air into the adapter, dispel the air into the bottle, and then turn the bottle upside down. Draw the prescribed amount of the oral suspension from the bottle and immediately dispense directly to the mouth after preparation.

Do not store a dose in the syringe for later use. After use, may wash the oral syringe with warm water and then dry the oral syringe for the next use. The bottle may be closed with the same cap without removing the bottle adapter.