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Cyclosporin A (CsA) is a potent immunosuppressant that  has many side effects, including hypertrichosis, gingival hyperplasia, and  tremor. To evaluate whether there is a relationship between the  CsA-pharmacokinetics (PK) and these side effects, their presence and intensity  were observed in 46 renal transplanted children/adolescents during two regular  visits, and the occurrence of the side effects was correlated with CsA-PK. CsA  doses had been unchanged for at least 6 mo. CsA blood concentrations were  measured at time 0, and 1, 2, and 4 h after the CsA morning dose. An  abbreviated area under the curve (AUC) was calculated using C0, C2, and C4.  Hypertrichosis positively correlated with C2, C4,  C  max ,  and AUC. An AUC ≥ 4158 ng/ml per h was the best predictor for the presence  of hypertrichosis. Tremor was also positively correlated with C2,   C  max , and AUC. A  C  max  ≥ 878 ng/ml  was the best predictor for the appearance of tremor. These values of   C  max  and AUC are within the therapeutic range of CsA as  demonstrated by the studies of calcineurin inhibition by CsA. Gingival  hyperplasia was not associated with any of the CsA-PK studied parameters.  However, it was associated with the concomitant use of nifedipine. These data  show that there is a correlation between the CsA side effects and its  pharmacokinetics and that it is possible to decrease the incidence and  intensity of such side effects by monitoring the CsA-PK parameters, providing  they are under or at the proposed cutoff levels. Nifedipine should also be  avoided to reduce the presence of gingival hyperplasia.

Impact of Cyclosporin A Pharmacokinetics on the Presence of Side Effects in Pediatric Renal Transplantation