APO-MYCOPHENOLATE

What it is

APO-MYCOPHENOLATE contains mycophenolate mofetil 250 mg as the active ingredient in capsule form. The capsules are opaque blue cap and opaque pink body in Size 1 capsules containing white to off white powder.

Approved indications

— Prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. — Prophylaxis of organ rejection in paediatric patients aged 2 to 18 years receiving allogeneic renal transplants.

Dosing overview

The recommended dose varies by transplant type: for renal transplantation in adults, 1 g administered orally twice daily (2 g daily dose); for cardiac transplantation, 1.5 g administered orally twice daily (3 g daily dose); for hepatic transplantation, 1 g administered intravenously twice daily (2 g daily dose) followed by 1.5 g administered orally twice daily (3 g daily dose). For paediatric patients aged 2 to 18 years receiving renal transplants, the recommended dose is 600 mg/m² administered orally twice daily, up to a maximum of 2 g daily.

Key safety warnings

Patients receiving mycophenolate mofetil as part of an immunosuppressive regime are at increased risk of developing lymphomas and other malignancies, particularly of the skin, with the risk appearing to be related to the intensity and duration of immunosuppression rather than the use of any specific agent. Patients should limit their exposure to sunlight and other sources of UV light by wearing protective clothing and using sunscreen with a high protection factor. Over suppression of the immune system can increase susceptibility to infection, including opportunistic infections, fatal infections and sepsis. Cases of progressive multifocal leukoencephalopathy (PML) associated with the JC virus, sometimes fatal, have been reported in mycophenolate mofetil-treated patients. Due to the cytostatic effect of mycophenolate mofetil on B- and T-lymphocytes, increased severity of COVID-19 may occur. Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents. Patients on mycophenolate mofetil should have complete blood counts weekly during the first month of treatment, twice monthly for the second and third months, then monthly through the first year. Patients should be monitored for neutropenia. If neutropenia develops (absolute neutrophil count <1.3 x 10³/µL), dosing should be interrupted or the dose reduced and the patient should be carefully observed. Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including uncommon cases of gastrointestinal tract ulceration, haemorrhage, and perforation. Gastrointestinal tract bleeding (requiring hospitalisation) has been observed in approximately 1.4% of patients treated with mycophenolate mofetil 2 g in renal transplantation, 2.8% receiving 3 g in cardiac transplantation and 5.4% receiving 3 g in hepatic transplantation.

Contraindications

APO-MYCOPHENOLATE is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil, mycophenolic acid or any component of the drug product. It is contraindicated during pregnancy and in women of childbearing potential not using highly effective contraceptive methods. APO-MYCOPHENOLATE is contraindicated in women who are breastfeeding.

PBS listing

No information regarding PBS listing is provided in the available source documents.

Regulatory history

APO-MYCOPHENOLATE mycophenolate mofetil 250 mg capsule variants were first listed on the ARTG on 2011-11-08.