MYFORTIC Gastro-resistant tablet Ref.[9668] Active ingredients: Mycophenolic acid

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

Posology

The recommended dose is 720 mg administered twice daily (1,440 mg daily dose). This dose of mycophenolate sodium corresponds to 1 g mycophenolate mofetil administered twice daily (2 g daily dose) in terms of mycophenolic acid (MPA) content.

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 72 hours following transplantation.

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).

Older people

The recommended dose in elderly patients is 720 mg twice daily.

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 monitored and the daily dose of Myfortic should not exceed 1,440 mg.

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 modification 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.

There have been reports of intentional or accidental overdoses with Myfortic, whereas not all patients experienced related adverse events.

In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the class (mainly blood dyscrasias, sepsis) (see sections 4.4 and 4.8).

Although dialysis may be used to remove the inactive metabolite MPAG, it would not be expected to remove clinically significant amounts of the active moiety MPA. This is in large part due to the very high plasma protein binding of MPA, 97%. By interfering with enterohepatic circulation of MPA, bile acid sequestrants, such as cholestyramine, may reduce the systemic MPA exposure.

Shelf life: 30 months.

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from moisture.

The tablets are packed in polyamide/aluminium/PVC/aluminium blister packs of 10 tablets per blister in quantities of 20, (180mg only), 50, 100, 120 or 250 tablets per carton.

Not all pack sizes may be marketed.

In order to retain the integrity of the enteric coating, Myfortic tablets should not be crushed (see section 4.2).

Mycophenolic acid has demonstrated teratogenic effects (see section 4.6). Where crushing of Myfortic tablets is necessary, avoid inhalation of the powder or direct contact of the powder with skin or mucous membrane.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.