Pharmacokinetic study of cyclosporin A (Sandimmun) in patients with primary biliary cirrhosis.

The pharmacokinetics of cyclosporin A (CS-A) were studied in 10 patients with primary biliary cirrhosis (PBC) after oral administration in steady state. Mean values for area under the blood concentration-time curve (AUC), time to maximal blood concentration (tmax), maximal blood concentration (Cmax) and elimination half-life (t1/2,z) were similar to results of previous studies in transplant patients. The variation between patients was large. No significant correlations of pharmacokinetic data with biochemical or histological parameters were found. Because of the high variability of pharmacokinetic parameters, patients with PBC treated with CS-A need to be regularly controlled for nephrotoxicity by estimation of serum creatinine and bioavailability (trough blood levels).