Bronchiectasis in children in association with mycophenolate mofetil

Introduction Cellcept, with mycophenolate mofetil (MMF) as active substance, was granted a marketing authorisation on 14 February 1996. On 16 July 2001, paediatric transplantations were included in the therapeutic indication. The current therapeutic indication is: Cellcept is indicated in combination with cyclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. The adult dose recommendation of 1 g bid was based on a dose finding study, in which 1.5 g bid revealed more undesirable effects with similar efficacy as compared with the dose of 1 g bid. The paediatric dose recommendation sounds: Children and adolescents (aged 2 to 18 years): the recommended dose of MMF is 600 mg/m administered orally twice daily (up to a maximum of 2 g daily). Cellcept capsules should only be prescribed to patients with a body surface area of at least 1.25 m. Patients with a body surface area of 1.25 to 1.5 m may be prescribed Cellcept capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area greater than 1.5 m may be prescribed Cellcept capsules at a dose of 1 g twice daily (2 g daily dose). These recommendations were based on adult pharmacokinetic parameters, presuming that the metabolism and mechanism of action of MMF in paediatric patients would be similar to adults. To decrease inter-patient variability, the paediatric dose recommendation is expressed in mg/m instead of mg/kg. In contrast with adult patients, paediatric pharmacokinetic parameters could hardly be related to efficacy and safety. The SPC recommends, outside the immediate post-transplant period, to limit the dosage to 1.0 g bid in case of severe renal impairment (GFR < 25 ml*min*1.73 m) [1].