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ZypAdhera Summary of Product Characteristics (SmPC)
ZypAdhera® (olanzapine pamoate): Measurement of Plasma Concentration
During treatment, dose may subsequently be adjusted on the basis of individual clinical status. Posology based on the Summary of Product Characteristics does not require mandatory measurement of plasma concentrations.
repeated intramuscular (IM) injections with 150 to 300 mg olanzapine
pamoate every two weeks, the 10th to 90th percentile of steady-state
plasma concentrations of olanzapine were between 4.2 and 73.2 ng/ml.1
plasma concentrations of olanzapine observed across the dose range of
150 mg every 4 weeks to 300 mg every 2 weeks illustrate increased
systemic olanzapine exposure with increased olanzapine pamoate
plasma clearance after oral olanzapine is lower in females (18.9
l/hr) versus males (27.3 l/hr), and in non-smokers (18.6 l/hr) versus
smokers (27.7 l/hr). Similar pharmacokinetic differences between
males and females and smokers and non-smokers were observed in
olanzapine pamoate clinical trials. However, the magnitude of the
impact of gender, or smoking on olanzapine clearance is small in
comparison to the overall variability between individuals.1
combination of the release profile and the dosage regimen
(intramuscular injection every two or four weeks) result in sustained
olanzapine plasma concentrations. Plasma concentrations remain
measurable for several months after each olanzapine pamoate
the olanzapine pamoate clinical trials, blood samples for the
assessment of olanzapine plasma concentration samples were collected
immediately prior to administration of olanzapine pamoate at that
visit, thus reflecting trough olanzapine concentration. 2,3
ZypAdhera [summary of product characteristics] Eli Lilly Netherland
B.V., The Netherlands.
Kane JM, Detke HC, Naber D, et al. Olanzapine long-acting injection:
a 24-week, randomized, double-blind trial of maintenance treatment in
patients with schizophrenia. Am J Psychiatry.
McDonnell DP, Landry J, Detke HC. Long-term safety and efficacy of
olanzapine long-acting injection in patients with schizophrenia or
schizoaffective disorder: a 6-year, multinational, single-arm,
open-label study. Int Clin Psychopharmacol.
Date of Last Review:April 12, 2018
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