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Pharmacokinetics of hydroxychloroquine in Japanese systemic lupus erythematosus patients with renal impairment.

OBJECTIVES
Reduction of the hydroxychloroquine (HCQ) dosage is recommended in SLE patients with renal impairment, but a pharmacokinetics (PK) study of patients with renal impairment has not yet been performed.


METHODS
We investigated the PK of both single and multiple doses of HCQ and its metabolites in SLE patients with renal impairment who newly started HCQ at a daily dose of 300 mg based on an ideal body weight dosage of 6.5 mg/kg. Population pharmacokinetic (PPK) analysis was performed using a nonlinear mixed-effects model.


RESULTS
In total, 219 samples from 21 patients were analyzed. The PK of HCQ in blood after a single and multiple oral administrations followed the 2-compartment model. At steady-state, the concentration ratio of HCQ to each metabolite was HCQ: desethylhydroxychloroquine: desethylchloroquine: bisdesethylchloroquine = 1: 0.28: 0.1: 0.06. The HCQ concentration correlated positively with that of each metabolite. The estimated values (relative standard error) of the PPK parameters were the total clearance at 110 L/h (31%) and a central volume of distribution of 398 L (19%). Co-administration of prednisolone and age, but not renal impairment, were factors affecting the total clearance of HCQ.


CONCLUSIONS
From the PK perspective, a dosage reduction is unnecessary in SLE patients with impaired renal function.