Atajec Dosage/Direction for Use

Treatment with mycophenolate mofetil should be initiated and maintained by appropriately qualified transplant specialists.
Dosage: Use in renal transplant: Adults: Oral mycophenolate mofetil 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).
Paediatric population aged 2 to 18 years: The recommended dose of mycophenolate mofetil is 600 mg/m² administered orally twice daily (up to a maximum of 2 g daily). Mycophenolate mofetil 500 mg 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 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.
Paediatric population <2 years: There are limited safety and efficacy data in children below the age of 2 years. These are insufficient to make dose recommendations and therefore use in this age group is not recommended.
Use in cardiac transplant: Adults: Oral mycophenolate mofetil 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).
Paediatric population: No data are available for paediatric cardiac transplant patients.
Use in hepatic transplant: Adults: Intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic transplant, with oral mycophenolate mofetil 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 g daily done).
Paediatric population: No data are available for paediatric hepatic transplant patients.
Use in special populations: Elderly: 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.
Renal impairment: 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 postoperatively. No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Severe hepatic 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.
Treatment during rejection episodes: Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dose reduction or interruption of mycophenolate mofetil in not required.
There is no basis for mycophenolate mofetil dose adjustment following cardiac transplant rejection. No pharmacokinetic data are available during hepatic transplant rejection.
Method of Administration: Oral administration.
Precautions to be taken before handling or administering the medicinal product: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, mycophenolate mofetil tablets should not be crushed.