MUREST-DR 360 DELAYED-RELEASE TABLETS 360MG

TABLET, DELAYED RELEASE

**DOSAGE AND ADMINISTRATION** **Dosage regimen** The recommended dose is 720 mg (four 180 mg or two 360 mg Murest-DR tablets administered twice daily (1440 mg daily dose). Murest-DR tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. **General target population** **Transplant patient** Treatment with Murest-DR tablets should be initiated and maintained by appropriately qualified transplant specialists. Murest-DR tablets should be initiated in de-novo patients within 48 hours following transplantation. Murest-DR tablets can be taken with or without food. **Lupus nephritis patients** Adequate dose finding studies have not been performed. The prescriber should adjust the dose based on clinical response. The dose may be tapered for maintenance purposes following a complete or partial response (see Clinical Studies section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Induction treatment with Murest-DR tablets is usually initially administered in combination with corticosteroids. **Special populations** **Renal impairment** No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section CLINICAL PHARMACOLOGY – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with severe chronic renal impairment (glomerular filtration rate 25 mL.min-1.1.73 m-2) should be carefully monitored. **Hepatic impairment** No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. **Pediatric patients (below 18 years old)** Safety and efficacy in pediatric patients have not been established. Limited pharmacokinetic data are available for pediatric renal transplant patients (see section CLINICAL PHARMACOLOGY – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Geriatric patients (65 years of age or above)** No dose adjustment is required in this patient population. **Treatment during rejection episodes** Renal transplant rejection does not lead to changes in mycophenolic acid pharmacokinetics; dosage reduction or interruption of Murest-DR is not required. **Method of administration** Murest-DR should not be crushed in order to maintain the integrity of the enteric coating (see sections CLINICAL PHARMACOLOGY and PHARMACEUTICAL INFORMATION – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).