Regulatory Information
GOLDPLUS UNIVERSAL PTE LTD
GOLDPLUS UNIVERSAL PTE LTD
Therapeutic
Prescription Only
Formulation Information
CAPSULE
**DOSAGE AND ADMINISTRATION** Please refer to full prescribing information for corticosteroids and either ciclosporin or tacrolimus, which are used in combination with Mofecon. 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 1.5 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 per day of Mofecon demonstrated an overall better safety profile compared to patients receiving 3 f per day of Mofecon. 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 administered 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. 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. The initial dose of Mofecon should be given as soon as possible following renal, cardiac or hepatic transplantation. **Special dosage instructions** Patients with neutropenia: If neutropenia develops (absolute neutrophil count <1.3 x 103/ml), dosing with Mofecon should be interrupted or the dose should be reduced and the patient carefully observed. For dosage instructions in special population, please refer to sections Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
ORAL
Medical Information
**INDICATIONS** Mofecon is indicated for: - prophylaxis of acute organ rejection and treatment of refractory organ rejection in patients receiving allogeneic renal transplants. - prophylaxis of acute organ rejection and increased graft and patient survival in patients receiving allogeneic cardiac transplants. - prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants. Mofecon should be used concomitantly with cyclosporin and corticosteroids.
**CONTRAINDICATIONS** Mofecon should not be given to: - Patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients shown above – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Women of childbearing potential who are not using highly effective contraception. - Women of childbearing potential without providing a pregnancy test result to rule out unintended use in pregnancy. - During pregnancy due to its mutagenic and teratogenic potential. - Women who are breastfeeding.
L04AA06
mycophenolic acid
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
CONCORD BIOTECH LIMITED
Active Ingredients
Documents
Package Inserts
MOFECON PI.pdf
Approved: January 31, 2023