Standard Dosage for prophylaxis of renal rejection: A dose of 1 g administered orally or intravenously (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 1.5g administered twice daily (daily dose of 3g) 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 2g per day of CellCept demonstrated an overall better safety profile compared to patients receiving 3g per day of CellCept.
Standard Dosage for prophylaxis of cardiac rejection: A dose of 1.5g administered orally or intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 3g) is recommended for use in cardiac transplant patients.
Standard Dosage for prophylaxis of hepatic rejection: A dose of 1.0g administred intravenousely (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2g) or 1.5g orally twice a day (daily dose of 3g) is recommended for use in hepatic transplant patients.
For Oral Administration only: Standard dosage for treatment of refractory renal rejection: A dose of 1.5 g administered twice a day (daily dose of 3g) is recommended for management of 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.
Intravenous administration: Caution: CellCept i.v. solution must not be administered by rapid or bolus intravenous injection.
CellCept i.v. is an alternative dosage form to CellCept capsules and tablets recommended for patients unable to take oral CellCept. CellCept i.v. should be administered within 24 hours following transplantation. CellCept i.v. can be administered for up to 14 days. Patients should be switched to oral CellCept as soon as they can tolerate oral medication.
Following reconstitution and dilution with 5% Dextrose intravenous infusion to a concentration of 6 mg/mL, CellCept i.v. must be administered by slow intravenous infusion over a period of NO LESS THAN 2 HOURS by either a peripheral or a central vein.
Special dosage instructions: Patients with neutropenia: If neutropenia develops (absolute neutrophil count <1.3 x 103/μl), dosing with CellCept should be interrupted or the dose should be reduced and the patient carefully observed (see Precautions).
For dosage instructions in special population, please refer to Renal Impairment, Hepatic Impairment and Use in the Elderly under Precautions.