Renal Transplantation
Adults
A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients. Although a dose of 1.5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients. Patients receiving 2 g/day of mycophenolate mofetil demonstrated an overall better safety profile than did patients receiving 3 g/day of mycophenolate mofetil.
Pediatrics (3 months to 18 years of age)
The recommended dose of Mycophenolate Mofetil oral suspension is 600 mg/m2 administered twice daily (up to a maximum daily dose of 2 g/10 mL oral suspension). Patients with a body surface area of 1.25 m2 to 1.5 m2 may be dosed with Mycophenolate Mofetil capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area >1.5 m2 may be dosed with Mycophenolate Mofetil capsules or tablets at a dose of 1 g twice daily (2 g daily dose).
Cardiac Transplantation
Adults
A dose of 1.5 g bid oral (daily dose of 3 g) is recommended for use in adult cardiac transplant patients.
Hepatic Transplantation
Adults
A dose of 1.5 g bid oral (daily dose of 3 g) is recommended for use in adult hepatic transplant patients.
Mycophenolate Mofetil Capsules, Tablets, and Oral Suspension
The initial oral dose of mycophenolate should be given as soon as possible following renal, cardiac or hepatic transplantation. Food had no effect on MPA AUC, but has been shown to decrease MPA Cmax by 40%. Therefore, it is recommended that mycophenolate be administered on an empty stomach. However, in stable renal transplant patients, mycophenolate may be administered with food if necessary.
Patients should be instructed to take a missed dose as soon as they remember, except if it is near the next scheduled dose, and then continue to take mycophenolate at the usual times.
Note:
If required, Mycophenolate Mofetil Oral Suspension can be administered via a nasagastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
Patients with Hepatic Impairment
No dose adjustments are recommended for renal patients with severe hepatic parenchymal disease. However, it is not known whether dose adjustments are needed for hepatic disease with other etiologies (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Geriatrics
The recommended oral dose of 1 g bid for renal transplant patients, 1.5 g bid for cardiac transplant patients, and 1.5 g bid administered orally in hepatic transplant patients is appropriate for elderly patients (see PRECAUTIONS: Geriatric Use).
Mycophenolate Mofetil Intravenous
Mycophenolate Mofetil Intravenous is an alternative dosage form to Mycophenolate Mofetil capsules, tablets and oral suspension recommended for patients unable to take oral mycophenolate. Mycophenolate Mofetil Intravenous should be administered within 24 hours following transplantation. Mycophenolate Mofetil Intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate as soon as they can tolerate oral medication.
Dosage Adjustments
In renal transplant patients with severe chronic renal impairment (GFR <25 mL/min/1.73 m2) outside the immediate posttransplant period, doses of mycophenolate greater than 1 g administered twice a day should be avoided. These patients should also be carefully observed. No dose adjustments are needed in renal transplant patients experiencing delayed graft function postoperatively (see CLINICAL PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS: Patients with Renal Impairment).
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. Mycophenolate may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
If neutropenia develops (ANC <1.3 x 103/µL), dosing with mycophenolate should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately (see WARNINGS: Neutropenia, ADVERSE REACTIONS, and PRECAUTIONS: Laboratory Tests).