Posology : מינונים

4.2     Posology and method of administration

Treatment should be initiated and maintained by appropriately qualified transplant specialists.
Posology

Use in renal transplant

Adults
Treatment 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).
Capsules should only be prescribed to patients with a body surface area of at least 1.25 m2. Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed mycophenolate mofetil capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area greater than 1.5 m2 may be prescribed mycophenolate mofetil capsules at a dose of 1 g twice daily (2 g daily dose).
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.

Paediatric population < 2 years
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.

Use in cardiac transplant

Adults
Treatment 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 (IV) CellCept should be administered for the first 4 days following hepatic transplant, with oral CellCept 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).

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 post-operatively (see section 5.2). 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; dosage reduction or interruption of 
CellCept is not required. There is no basis for CellCept dose adjustment following cardiac transplant rejection. No pharmacokinetic data are available during hepatic transplant rejection.

Paediatric population
No data are available for treatment of first or refractory rejection in paediatric transplant patients.

Method of administration
For oral use

Precautions to be taken before handling or administering the medicinal product.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in the capsules. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
CellCept tablets should not be crushed.