Mycophenolic Acid reaches therapeutic levels whereas mycophenolate mofetil does not.

BACKGROUND: In kidney transplanted children, it is difficult to obtain blood levels of mycophenolic acid between 2 and 4 microg/mL, when mycophenolate mofetil doses up to 30 mg/kg/d are given two or three times a day. We proposed that using mycophenolic acid, instead of the salt mycophenolate mofetil, may help us to reach target levels. AIM: We sought to describe the pharmacokinetics of mycophenolic acid in eight kidney transplanted children over a period of 1.2 +/- 0.8 years. PATIENTS AND METHODS: Eight patients (5 boys and 3 girls) aged 7.0 +/- 1.8 years received cadaveric kidney transplantations. Induction with basiliximab was followed by cyclosporine (n = 4) or tacrolimus (n = 4), tapered steroids (withdrawal at 12 months in six cases and maintained at 0.15 mg/kg/d in two cases), and mycophenolate mofetil (25 to 30 mg/kg/d two or three times a day). For 1.0 +/- 0.3 years mycophenolic acid levels were between 0.8 +/- 0.3 microg/mL. When mycophenolic acid sodium tablets were available, all patients were switched to this drug. RESULTS: After the conversion, blood levels obtained at 8 +/- 3 days were 1.5 to 5.0 microg/mL (median, 3.2), which were far closer to the target 2 to 4 microg/mL. No gastrointestinal disorders were observed with the follow-up of 72 +/- 18 days. CONCLUSION: Mycophenolic acid sodium reaches therapeutic levels whereas mycophenolate mofetil does not. If mycophenolic acid were available in syrup form, it could be used in patients under 5 years of age. It is necessary to follow these patients to rule out enzymatic induction.

Immunoprophylaxis with Simulect (basiliximab) in pediatric kidney transplant recipients: results from routine clinical practice at 5 kidney transplant units.

BACKGROUND: Simulect (basiliximab) was introduced in Spain in February 1999, being the first anti-interleukin-2 receptor monoclonal antibody used in our country for the prevention of acute rejection in kidney transplantation. The objective of this study was to assess the efficacy and safety of Simulect (basiliximab) in routine clinical practice in pediatric Spanish kidney transplantation units. METHODS: In this prospective, observational study, we collected data related to demographics, parameters of efficacy, immunosuppressive therapy, and safety on kidney transplant patients treated with Simulect (basiliximab) using an on-line collection system. RESULTS: Fifty pediatric patients at 5 kidney transplant units with 12 months follow-up included recipient mean age of 10.00 years (DS 5.40). Twenty-nine (58.00%) were boys and 21 (42.00%) were girls. Cold ischemia time was 15 hours and 50 minutes (DS 9.70 h). No patient presented with a PRA >50%. For prophylactic immunosuppression, 85.70% of patients received triple therapy with CNI (cyclosporine 48.97% or tacrolimus 36.73%), MMF (87.76%) or AZA (12.24%), and steroids. Acute rejection incidence at 12 months was 22%, including 3 steroid-resistant episodes (6%). One patient lost the graft (2%), 7 adverse events (AE) were reported (1 mild, 4 moderate, and 1 severe AE), of which none were attributed to the study drug. CONCLUSIONS: Simulect (basiliximab) treatment of pediatric patients who underwent kidney transplantations performed in routine clinical practice showed good prophylaxis against acute rejection with excellent safety.