Summary

• Lower maximum serum concentration (C_max) was observed in overweight and obese patients. At apparent steady-state with INVEGA HAFYERA, the trough concentrations were similar among normal, overweight, and obese subjects.¹
• A population pharmacokinetic (popPK) model-based simulation of paliperidone pharmacokinetics (PK) after the administration of INVEGA HAFYERA using data from the phase 3, double-blind (DB), noninferiority study reported that following exposure to INVEGA HAFYERA 1560 mg (1000 mg equivalent [eq.]) or 1092 mg (700 mg eq.) the median C_max decreased by 7.0% for overweight and 15.9% for obese patients compared to patients with normal weight.²

CLINICAL DATA

T’jollyn et al (2024)² reported a popPK model-based simulation that characterized the PK of INVEGA HAFYERA to provide guidance on different dosing scenarios (initiation, maintenance, and missed doses) and dosing in special populations, including based on body mass index (BMI). Data was sourced from the phase 3, DB, noninferiority study³ that evaluated the efficacy and safety of INVEGA HAFYERA for the treatment of adult patients with schizophrenia who were previously stabilized on INVEGA SUSTENNA or INVEGA TRINZA.

Study Design/Methods

• The popPK model utilized structural covariates creatinine clearance, BMI, and sex to evaluate the influence on paliperidone PK after INVEGA HAFYERA administration in special populations. For the definition of BMI covariate used in the analysis, see Table: Covariate - Body Mass Index.

Results

• The PK dataset comprised 15,932 samples from 700 patients from the DB study (male, 68.4%, median [range] age, 40.0 [18-69] years; median [range] BMI, 27.2 [17.2-39.8] kg/m²; INVEGA TRINZA, 5148 [32%] samples from 223 patients; INVEGA HAFYERA, 10,784 [68%] samples from 477 patients).
• After both doses of INVEGA HAFYERA (1560 mg [1000 mg eq.] and 1092 mg [700 mg eq.]), the median C_max decreased for overweight (–7.0%) and obese (–15.9%) patients compared to patients with normal body weight; the median trough concentrations were similar across all BMI subgroups.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 12 September 2024.