Mofecon-C 250/Mofecon 500 Dosage/Direction for Use

Recommended dose: 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 Mofecon-C 250/Mofecon 500 demonstrated an overall better safety profile compared to patients receiving 3 g/day of Mofecon-C 250/Mofecon 500.
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: The initial dose of Mofecon-C 250/Mofecon 500 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.
Mofecon-C 250/Mofecon 500 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).
Geriatric use: For transplant patients, no oral dosage adjustment is recommended.
For lupus nephritis patients, no recommendation is available.
Renal function impairment: Renal transplant: In patients with severe chronic renal impairment (glomerular filtration rate less than 25 mL/minute/1.73 m²) outside the immediate posttransplant period or after treatment of acute or refractory rejection. Doses greater than 1 g administered twice daily should be avoided: patients should also be carefully observed; no dose adjustments are needed in renal transplant patients experiencing delayed graft function postoperatively.
For post-transplant patients with delayed renal graft function, no dose adjustment is recommended but patients should be carefully monitored.
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.
Hemodialysis: Not removed: supplemental dose is not necessary.
Peritoneal dialysis: Supplemental dose is not necessary.
Hepatic Impairment: No dosage adjustment is recommended for renal transplant patients with severe hepatic parenchymal disease: however, it is not currently known whether dosage adjustments are necessary for hepatic disease with other etiologies.
For cardiac transplant and lupus nephritis patients with severe hepatic parenchymal disease, no data are available.
Dosage adjustment: Neutropenia: If neutropenia develops (absolute neutrophil counts [ANCs] less than 1.3 x 10³/mcL), interrupt dosing or reduce the dosage of mycophenolate, perform appropriate diagnostic test, and manage the patient appropriately.
Mode of administration: Oral: Oral dosage formulations should be administered on an empty stomach (1 hour before or 2 hours after meals).
If a dose is missed administer as soon as it is remembered. If it is close to the next scheduled dose, skip the missed dose and resume at next regularly scheduled time; do not double a dose to make up for a missed dose.