CELLCEPT Capsules, hard Ref.[8144] Active ingredients: Mycophenolate mofetil

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

Posology

Adults

Renal transplant

Treatment should be initiated within 72 hours following transplantation. The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).

Cardiac transplant

Treatment should be initiated within 5 days following transplantation. The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).

Hepatic transplant

Treatment of intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic transplant, with oral mycophenolate mofetil initiated as soon after this as it can be tolerated. The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).

Paediatric population (1 to 18 years)

The paediatric dosing information in this section applies to all oral formulations within the range of mycophenolate mofetil products, as appropriate. Different oral formulations should not be substituted without clinical supervision.

The recommended mycophenolate mofetil initial dose for paediatric renal, cardiac and hepatic transplant patients is 600 mg/m² (of body surface area (BSA)), administered orally, twice daily (initial total daily dose not to exceed 2 g, or 10 ml of the oral suspension).

The dose and product form should be individualised based on clinical assessment. If the recommended initial dose is well tolerated but does not achieve clinically adequate immunosuppression in paediatric cardiac and hepatic transplant patients, the dose can be increased to 900 mg/m² BSA twice daily (maximum total daily dose of 3 g, or 15 ml of the oral suspension). The recommended maintenance dose for paediatric renal transplant patients remains at 600 mg/m² twice daily (maximum total daily dose of 2 g or 10 ml of the oral suspension).

The mycophenolate mofetil powder for oral suspension should be used in those patients unable to swallow capsules and tablets and/or with a BSA lower than 1.25 m² due to the increased risk of choking. Patients with a BSA of 1.25 to 1.5 m² may be prescribed mycophenolate mofetil capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a BSA greater than 1.5 m² may be prescribed mycophenolate mofetil capsules or tablets at a dose of 1 g twice daily (2 g daily dose). As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.

Use in special populations

Elderly

The recommended dose of 1 g administered twice a day for renal transplant patients and 1.5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.

Renal impairment

In renal transplant patients with severe chronic renal impairment (glomerular filtration rate <25 ml/min/1.73 m²), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided. These patients should also be carefully observed. No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section 5.2). No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.

Severe hepatic impairment

No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. No data are available for cardiac transplant patients with severe hepatic parenchymal disease.

Treatment during rejection episodes

Adults

Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dose reduction or interruption of treatment is not required. There is no basis for dose adjustment following cardiac transplant rejection. No pharmacokinetic data are available during hepatic transplant rejection.

Paediatric population

No data are available for treatment of first or refractory rejection in paediatric transplant patients.

Method of administration

For oral use.

Precautions to be taken before handling or administering the medicinal product

Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in the capsules. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.

Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience. In the vast majority of these cases, either no adverse events were reported or they were in line with the known safety profile of the medicinal product and had a favourable outcome. However, isolated serious adverse events including a fatal case were observed during post- marketing experience.

It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 4.4). If neutropenia develops, dosing with mycophenolate mofetil should be interrupted or the dose reduced (see section 4.4).

Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG. Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic recirculation of the drug (see section 5.2).

3 years.

Do not store above 25°C. Store in the original package in order to protect from moisture.

PVC/aluminium foil blister strips

CellCept 250 mg capsules:

1 carton contains 100 capsules (in blister packs of 10)

1 carton contains 300 capsules (in blister packs of 10)

multipacks containing 300 (3 packs of 100) capsules

Not all pack sizes may be marketed.

This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.