CellCept Dosage/Direction for Use

Refer to full prescribing information for corticosteroids and either ciclosporin or tacrolimus, which are used in combination with Mycophenolate mofetil (CellCept).
Transplant patients: Standard dosage for prophylaxis of renal rejection: Adults: A dose of 1 g administered orally (over NO LESS THAN 2 HOURS) 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 (CellCept) demonstrated an overall better safety profile compared to patients receiving 3 g/day of Mycophenolate mofetil (CellCept).
Children (aged 3 months to 18 years): Patients with a body surface area > 1.5 m² may be prescribed Mycophenolate mofetil (CellCept) tablets at a dose of 1 g twice daily (2 g daily dose).
Standard dosage for prophylaxis of cardiac rejection: Adults: A dose of 1.5 g administered orally (over NO LESS THAN 2 HOURS) twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
Children: No data are available for pediatric cardiac transplant patients.
Standard dosage for prophylaxis of hepatic rejection: Adults: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for use in hepatic transplant patients.
Children: No data are available for pediatric hepatic transplant patients.
Standard dosage for treatment of first or refractory renal rejection: Adults: A dose of 1.5 g administered orally (over NO LESS THAN 2 HOURS) twice a day (daily dose of 3 g) is recommended for management of first or refractory rejection.
Children: No data are available for treatment of first or refractory renal rejection in pediatric renal transplant patients.
Oral administration (see Pharmacology: Pharmacokinetics: Absorption under Actions): The initial dose of Mycophenolate mofetil (CellCept) should be given as soon as possible following renal, cardiac or hepatic transplantation.
Lupus nephritis patients: Standard Dosage for Induction Therapy: Adults: A dose of 750 mg-1.5 g administered orally twice a day (daily dose of up to 3 g) is recommended.
Children: A dose of 600 mg/m² administered orally twice a day (up to a maximum of 2 g daily) is recommended.
Standard Dosage for Maintenance Therapy: Adults: A dose of 500 mg-1 g administered orally twice a day is recommended.
Children: A dose of 300 mg/m² administered orally twice a day is recommended.
Mycophenolate mofetil (CellCept) should be used in combination with corticosteroids. Doses should be introduced gradually and adjusted according to clinical response. Therapeutic drug monitoring could help prevent sub-therapeutic exposure (C_min ≥3.0 mg/L or inter-dose AUC ≥35 h*mg/L).
Special Dosage Instructions: Pediatric use: See previous text and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
Geriatric use: For transplant patients, no oral dosage adjustment is recommended (see Precautions).
For lupus nephritis patients, no recommendation is available.
For IV administration of Mycophenolate mofetil (CellCept), no recommendation is available.
Renal impairment: For renal transplant patients with severe chronic renal impairment (glomerular filtration rate <25 mL/min/1.73 m²) outside of the immediate post-transplant period or after treatment of acute or refractory rejection, administration of doses greater than 1 g twice daily should be avoided (see Pharmacology: Pharmacokinetics under Actions).
For post-transplant patients with delayed renal graft function, no dose adjustment is recommended but patients should be carefully monitored (see Pharmacology: Pharmacokinetics under Actions).
For cardiac or hepatic transplant patients with severe renal impairment, no data are available.
For lupus nephritis patients with GFR <30 mL/min, therapeutic drug monitoring is advised.
Hepatic impairment: For renal transplant patients with severe hepatic parenchymal disease, no dose adjustments are recommended (see Pharmacology: Pharmacokinetics under Actions).
For cardiac transplant and lupus nephritis patients with severe hepatic parenchymal disease, no data are available.
Patients with neutropenia: For patients that develop neutropenia (absolute neutrophil count <1.3 x 10³/μL), dosing with Mycophenolate mofetil (CellCept) should be interrupted or the dose should be reduced (see Precautions).