- 250 mg - Mycophenolate mofetil.
Without a Prescription
Mycophenolate is prescribed in combination with ciclosporine and corticosteroids for the prophylaxis of acute transplant rejection
in patients receiving allogeneic renal, cardiac or hepatic transplants.
Use in renal transplant:
Children (< 2 years): There are limited safety and efficacy data in children below the age of 2 years. These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Children and adolescents (aged 2 to 18 years): Mycophenolate recommended dosage of mycophenolate mofetil is 600 mg/m 2 administered orally twice daily (up to a maximum of 2 g daily). Mycophenolate capsules should only be prescribed to patients with a body surface area of at least 1.25 m 2 . Patients with a body surface area of 1.25 to 1.5 m 2 may be prescribed Mycophenolate 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 2 may be prescribed Mycophenolate capsules at a dose of 1 g twice daily (2 g daily dose). As some adverse reactions occur with greater frequency in this age group compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Adults: Oral Mycophenolate should be initiated within 72 hours following transplantation. Mycophenolate recommended dosage in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Use in cardiac transplant:
Children: No data are available for paediatric cardiac transplant patients.
Adults: Oral Mycophenolate should be initiated within 5 days following transplantation. Mycophenolate recommended dosage in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Use in hepatic transplant:
Use in elderly ( > 65 years): Mycophenolate recommended dosage of 1 g administered twice a day for renal transplant patients and 1.5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
Children: No data are available for paediatric hepatic transplant patients.
Adults: IV Mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Mycophenolate initiated as soon after this as it can be tolerated. Mycophenolate recommended oral dosage in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Use in renal impairment: In renal transplant patients with severe chronic renal impairment, outside the
immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided. These patients should
also be carefully observed. No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively. No
data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Use in severe hepatic impairment: No dose adjustments are needed for renal transplant patients with severe hepatic
parenchymal disease. No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Treatment during rejection episodes: MPA (mycophenolic acid) is the active metabolite of mycophenolate mofetil. Renal
transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of Mycophenolate is not
required. There is no basis for Mycophenolate dose adjustment following cardiac transplant rejection. No pharmacokinetic data are available during hepatic transplant rejection.
Hypersensitivity reactions to Mycophenolate have been observed. Therefore, Mycophenolate is contraindicated in patients with a hypersensitivity to
mycophenolate mofetil or mycophenolic acid. Mycophenolate is contraindicated in women who are breastfeeding.
Blister strip of 10 capsules