Active Ingredient: Mycophenolate mofetil
Mycophenolate mofetil is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic hepatic transplants.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1 grams mycophenolate mofetil, 2 times daily, over the duration of 4 days.
The recommended dose of mycophenolate mofetil for infusion in hepatic transplant patients is 1 g administered twice daily (2 g daily dose). Intravenous mycophenolate mofetil should continue for the first 4 days following hepatic transplant, with oral mycophenolate mofetil initiated as soon after this as it can be tolerated. The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Following reconstitution to a concentration of 6 mg/ml, mycophenolate mofetil 500 mg powder for concentrate for solution for infusion must be administered by slow intravenous infusion over a period of 2 hours by either a peripheral or a central vein.
For:
Oral, 1.5 grams mycophenolate mofetil, 2 times daily.
Treatment of intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic transplant, with oral mycophenolate mofetil initiated as soon after this as it can be tolerated. The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
For:
Regimen A
Oral, 600 milligrams mycophenolate mofetil per square meter of body surface, 2 times daily.
Regimen B
Oral, 600 milligrams mycophenolate mofetil per square meter of body surface, 2 times daily. Afterwards, in case that there is poor response to treatment, oral, 900 milligrams mycophenolate mofetil per square meter of body surface, 2 times daily.
The recommended mycophenolate mofetil initial dose for paediatric hepatic transplant patients is 600 mg/m² (of body surface area (BSA)), administered orally, twice daily (initial total daily dose not to exceed 2 g).
The dose and product form should be individualised based on clinical assessment. If the recommended initial dose is well tolerated but does not achieve clinically adequate immunosuppression in hepatic transplant patients, the dose can be increased to 900 mg/m² BSA twice daily (maximum total daily dose of 3 g).
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.
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