Posology : מינונים

4.2   Posology and method of administration

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

The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic film coated tablets) administered twice daily (1,440 mg daily dose). In patients receiving mycophenolate mofetil (MMF) 2 g, treatment can be replaced by 720 mg administered twice daily (1,440 mg daily dose) of Myfortic.

For additional information about the corresponding therapeutic doses of mycophenolate sodium and mycophenolate mofetil, see sections 4.4 and 5.2.

In de novo patients, Myfortic should be initiated within 48 hours following transplantation.



MYF API March23 V3                                                                             REF UK SmPC March23 Special population

Paediatric population
Insufficient data are available to support the efficacy and safety of Myfortic in children and adolescents. Limited pharmacokinetic data are available for paediatric renal transplant patients (see section 5.2).

Geriatric patients
No dose adjustment is required in this patient population.

Patients with renal impairment
In patients experiencing delayed renal graft function post-operatively, no dose adjustments are needed (see section 5.2).
Patients with severe renal impairment (glomerular filtration rate <25 ml·min-1·1.73 m-2) should be carefully followed up.

Patients with hepatic impairment
No dose adjustments are needed for renal transplant patients with severe hepatic impairment.

Treatment during rejection episodes
Renal transplant rejection does not lead to changes in mycophenolic acid (MPA) pharmacokinetics; dosage reduction or interruption of Myfortic is not required.

Method of administration
Myfortic can be taken with or without food. Patients may select either option but must adhere to their selected option (see section 5.2).

In order to retain the integrity of the enteric coating, Myfortic tablets should not be crushed.
Where crushing of Myfortic tablets is necessary, avoid inhalation of the powder or direct contact of the powder with skin or mucous membrane. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water. This is due to the teratogenic effects of mycophenolate.