MYFORTIC GASTRO-RESISTANT TABLET 360 MG [SIN12377P]

Product Info

MYFORTIC GASTRO-RESISTANT TABLET 360 MG

[SIN12377P]

INDICATIONS

Myfortic is indicated in combination with ciclosporin for microemulsion and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.

Myfortic is indicated for induction and maintenance treatment of adult patients with ISN/RPS Class III, IV or V lupus nephritis.

The evidence for efficacy was based on surrogate endpoints in studies where the majority of patients with lupus nephritis were ISN/RPS (2003) Class IV (see Clinical Studies section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

DOSAGE REGIMEN AND ADMINISTRATION

Dosage regimen

The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic gastro-resistant tablets) twice daily (1440 mg daily dose). Myfortic delayed-release 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 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.

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 Myfortic is usually initially administered in combination with corticosteroids.

Special populations

Renal impairment

No dose adjustments are needed in patients experiencing delayed post-operative renal graft function (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 affect mycophenolic acid pharmacokinetics; dosage reduction or interruption of Myfortic is not required.

Method of administration

Myfortic tablets 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).

CONTRAINDICATIONS

Myfortic is contraindicated in patients with hypersensitivity to mycophenolate sodium, mycophenolic acid or mycophenolate mofetil or to any of the excipients, and in pregnant women. (see section DESCRIPTION AND COMPOSITION – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).