Dosage: The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic gastro-resistant 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.
General target population: Treatment with Myfortic should be initiated and maintained by appropriately qualified transplant specialists.
Myfortic should be initiated in de-novo patients within 48 hours following transplantation.
Myfortic can be taken with or without food.
Special populations: Paediatric patients: Safety and efficacy in paediatric patients have not been established. Limited pharmacokinetic data are available for paediatric renal transplant patients (see Pharmacology under Actions). Its use in these patients group therefore cannot be recommended.
Geriatric patients: No dose adjustment is required in this patient population.
Renal impairment: No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see Pharmacology: Pharmacokinetics under Actions). Patients with severe chronic renal impairment (creatinine clearance < 10 ml/min) should be carefully followed up.
Hepatic impairment: No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Lupus nephritis patients: Adequate dose finding studies have not been performed. The prescriber should adjust the dose based on clinical response.
Induction treatment with Myfortic is administered in combination with a corticosteroid. The recommended dose is 720 mg administered twice daily (1440 mg daily dose). A daily dose of greater than 1440 mg/day has been used for induction therapy in some studies, with the maximum dose of 2160 mg/day (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions). This dose may be tapered for maintenance purposes following a complete or partial response.
Method of administration: Myfortic tablets should not be crushed in order to remain the integrity of the enteric coating (see Pharmacology under Actions and Cautions for Usage).
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