CellCept Dosage/Direction for Use

Transplant patients: Standard dosage for prophylaxis of renal rejection: 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 CellCept demonstrated an overall better safety profile compared to patients receiving 3 g/day of CellCept.
Standard dosage for prophylaxis of cardiac rejection: A dose of 1.5 g administered orally twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
Standard dosage for prophylaxis of hepatic rejection: A dose of 1 g administered twice a day (daily dose of 2 g) or 1.5 g orally twice a day (daily dose of 3 g) is recommended for use in hepatic transplant patients.
Standard dosage for treatment of first or refractory renal rejection: A dose of 1.5 g administered orally twice a day (daily dose of 3 g) is recommended for management of first or refractory rejection.
Oral administration (see Pharmacology: Pharmacokinetics: Absorption under Actions): The initial dose of CellCept should be given as soon as possible following renal, cardiac or hepatic transplantation.
Lupus nephritis patients: Standard Dosage for Induction Therapy: A dose of 750mg - 1.5g administered orally twice a day (daily dose of up to 3g) is recommended.
Standard Dosage for Maintenance Therapy: A dose of 500mg - 1g administered orally twice a day is recommended.
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: Geriatric use: For transplant patients, no oral dosage adjustment is recommended (see Precautions).
For lupus nephritis patients, no recommendation is available.
Renal impairment: For renal transplant patients with severe chronic renal impairment (glomerular filtration rate <25 mL/min/1.73m²) outside of the immediate post-transplant period or after treatment of acute or refractory rejection, administration of doses greater than 1g 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<30mL/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 CellCept should be interrupted or the dose should be reduced (see Precautions).