MYCOKEM 500 Film-coated tablet Ref.[50464] Active ingredients: Mycophenolate mofetil

The initial dose of Mycokem 500 should be given as soon as clinically feasible following transplantation. Intravenous administration is recommended in those patients unable to take oral medication. However, oral administration should be initiated as soon as possible.

Adults

Renal Transplantation

The recommended dose in renal transplant patients is 1 g administered orally or intravenously twice daily (2 g daily dose).

Cardiac Transplantation

The recommended dose in cardiac transplant patients is 1.5 g administrated orally or intravenously twice daily (3 g daily dose).

Hepatic Transplantation

The recommended dose in hepatic transplant patients is 1 g administrated intravenously twice daily (2 g daily dose) followed by 1.5 g administered orally twice daily (3 g daily dose).

Other Transplants

The recommended dose in other transplants is 2 to 3 g per day depending on the level of immunosuppression required.

Paediatrics (2 to 18 years)

The recommended dose of for renal transplant patients is 600mg/m² of mycophenolate mofetil (MMF) administered orally twice daily (up to a maximum of 2 g daily.)

Mycokem 500 may be administered in combination with ciclosporin and corticosteroids.

Complete blood counts should be performed weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year. If neutropenia develops (ANC <1.3 × 10⁹/L), dosing with mycophenolate mofetil tablets should be interrupted and the patient carefully observed (see Section 4.4 Special warnings and precautions for use).

Patients should be advised to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.

In renal transplant patients with severe chronic renal impairment (GFR <25 mL/minute/1.73m²) outside of the immediate post-transplant period, doses of mycophenolate mofetil tablets greater than 1 g administered twice a day should be avoided. No data are available in cardiac or hepatic allograft recipients with severe chronic renal impairment. These patients should also be carefully observed. No dose adjustments are needed in patients experiencing delayed renal allograft function postoperatively.

No dosage adjustment is required in the elderly or in renal transplant patients with hepatic parenchymal disease.

No data are available for cardiac transplant patients with severe hepatic parenchymal disease.

Symptoms

Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience. In many of these cases no adverse events were reported. In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the drug.

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

Treatment

Mycophenolic acid cannot be removed by haemodialysis. However, at high glucuronide of mycophenolic acid plasma concentrations (>100 μg /ml), small amounts of glucuronide of mycophenolic acid are removed. Bile acid sequestrants, such as cholestyramine, can remove mycophenolic acid by increasing excretion of the drug (see Section 5.2 Pharmacokinetic properties).

Treatment of overdosage should consist of general supportive measures.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Mycokem 500 should be stored below 25°C and protected from light.

Mycokem 500 (AUST R No. 164418) are available in blister packs of 150 Tablets.

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Mycophenolate mofetil has demonstrated teratogenic effects (see sections 4.4 Special warnings and precautions for use and 4.6 Fertility, Pregnancy and Lactation),,therefore Mycokem 500 should not be crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder. If contact occurs, wash thoroughly with soap and water, should the eyes be affected, rinse eyes with plain water.