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Cellmune Structure
- 250 mg - mycophenolate mofetil.
Cellmune Indications
Cellmune is indicated in combination with ciclosporine and corticosteroids for the prophylaxis of acute transplant rejection
in patients receiving allogeneic renal, cardiac or hepatic transplants.
Cellmune Dosage
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): Cellmune recommended dosage of mycophenolate mofetil is 600 mg/m 2 administered orally twice daily (up to a maximum of 2 g daily). Cellmune 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 Cellmune 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 Cellmune 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 Cellmune should be initiated within 72 hours following transplantation. Cellmune 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 Cellmune should be initiated within 5 days following transplantation. Cellmune 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): Cellmune 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 Cellmune should be administered for the first 4 days following hepatic transplant, with oral Cellmune initiated as soon after this as it can be tolerated. Cellmune 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 Cellmune is not
required. There is no basis for Cellmune dose adjustment following cardiac transplant rejection. No pharmacokinetic data are available during hepatic transplant rejection.
Cellmune Contraindications
Hypersensitivity reactions to Cellmune have been observed. Therefore, Cellmune is contraindicated in patients with a hypersensitivity to
mycophenolate mofetil or mycophenolic acid. Cellmune is contraindicated in women who are breastfeeding.
Cellmune Form
Blister strip of 10 capsules
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