Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Passauer Pharma GmbH, Eiderstedter Weg 3, 14129 Berlin, Germany, Tel.: 0049 (0)30 744 60 12, Fax: 0049 (0)30 744 60 41
Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Treatment with Myclausen should be initiated and maintained by appropriately qualified transplant specialists.
Oral Myclausen should be initiated within 72 hours following transplantation. The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
The recommended dose of mycophenolate mofetil is 600 mg/m² administered orally twice daily (up to a maximum of 2 g daily). Myclausen film-coated tablets should only be prescribed to patients with a body surface area greater than 1.5 m², at a dose of 1 g twice daily (2 g daily dose). As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
There are limited safety and efficacy data in children below the age of 2 years. These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Oral Myclausen should be initiated within 5 days following transplantation. The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
No data are available for paediatric cardiac transplant patients.
Intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic transplant, with oral Myclausen initiated as soon after this as it can be tolerated. The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
No data are available for paediatric hepatic transplant patients.
The recommended dose of 1 g administered twice a day for renal transplant patients and 1.5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate <25 mL/min/1.73 m²), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided. These patients should also be carefully observed. No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section 5.2). No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of Myclausen is not required. There is no basis for Myclausen dose adjustment following cardiac transplant rejection. No pharmacokinetic data are available during hepatic transplant rejection.
No data are available for treatment of first or refractory rejection in paediatric transplant patients.
Oral administration. The film-coated tablets should be swallowed whole with a glass of water.
Precautions to be taken before handling or administering the medicinal product.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myclausen film-coated tablets should not be broken or crushed.
Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience. In many of these cases, no adverse events were reported. In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the medicinal product.
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 4.4). If neutropenia develops, dosing with Myclausen should be interrupted or the dose reduced (see section 4.4).
Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG. Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic recirculation of the drug (see section 5.2).
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
PVC-aluminium blisters containing 10 film-coated tablets.
Each carton contains either 50 or 150 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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