CEPTAVA Gastro-resistant tablet Ref.[27641] Active ingredients: Mycophenolic acid

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

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 (2g 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, Ceptava should be initiated within 72 hours following transplantation.

Ceptava 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, Ceptava tablets should not be crushed. Where crushing of Ceptava 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.

Paediatric population and adolescents

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

Elderly

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

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 <25ml·min^-1·1.73m^-2) should be carefully monitored and the daily dose of Ceptava should not exceed 1,440mg.

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 Ceptava is not required.

There have been reports of intentional or accidental overdoses with mycophenolate sodium, 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.

30 months.

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

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

PA/AL/PVC-aluminium blister packs.

Pack sizes:

20, 50, 100, 120, 250 gastro-resistant tablets.

Not all pack sizes may be marketed.

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

Mycophenolic acid has demonstrated teratogenic effects (see section 4.6). Where crushing of this medicine 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.