MOFECON 250 CAPSULES 250 MG [SIN16011P]

Product Info

MOFECON 250 CAPSULES 250 MG

[SIN16011P]

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.

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.

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.