MOFIT

What it is

MOFIT contains mycophenolate mofetil (MMF), with the 250 mg formulation presented as capsules and the 500 mg formulation as tablets. MMF is a white to off-white crystalline powder.

Approved indications

— Prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants — Prophylaxis of organ rejection in paediatric patients aged 6 to 18 years receiving allogeneic renal transplants

Dosing overview

The initial dose of MOFIT should be given as soon as clinically feasible following transplantation. 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 (Absolute Neutrophil Count < 1.3 × 10⁹/L), dosing with MOFIT should be interrupted or the dose reduced and the patient carefully observed. MOFIT may be administered in combination with ciclosporin and corticosteroids.

Key safety warnings

Female patients of childbearing potential must use effective contraception before, during and for six weeks after receiving MMF. MMF is contraindicated during pregnancy and during breastfeeding. Men should not donate semen during therapy and for 90 days following discontinuation of MMF. Patients receiving MMF as part of an immunosuppressive regime are at an increased risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to the intensity and duration of immunosuppression rather than the use of any specific agent. Patients should be advised to 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 patients treated with MMF. Hemiparesis, apathy, confusion, cognitive deficiencies and ataxia were the most frequent clinical features observed. BK virus-associated nephropathy has been observed during the use of MMF in patients post-renal transplant. This infection can be associated with serious outcomes, sometimes leading to renal graft loss. Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MMF in combination with other immunosuppressive agents. Patients receiving MMF should be instructed to immediately report any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression. Patients on MMF 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. In particular, patients receiving MMF should be monitored for neutropenia. There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving MMF in combination with other immunosuppressants. In some of these cases, switching MMF to an alternative immunosuppressant resulted in serum IgG levels returning to normal. Patients on MMF who develop recurrent infections should have their serum immunoglobulins measured. There have been published reports of bronchiectasis in adults and children who received MMF in combination with other immunosuppressants. In some of these cases, switching MMF to another immunosuppressant resulted in improvement in respiratory symptoms. The risk of bronchiectasis may be linked to hypogammaglobulinaemia or to a direct effect on the lung. MMF has been associated with an increased incidence of digestive system adverse events, including uncommon cases of gastrointestinal tract ulceration, haemorrhage, and perforation (colon, gall bladder). MMF should be administered with caution in patients with active serious digestive system disease.

Contraindications

MOFIT is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to MMF, to mycophenolic acid (MPA) or any component of the capsules and tablets. MOFIT is contraindicated during pregnancy and in women of childbearing potential not using highly effective contraceptive methods due to its mutagenic and teratogenic potential. MOFIT is contraindicated in women who are breastfeeding.

PBS listing

Information regarding PBS listing is not available in the provided source documents.

Regulatory history

MOFIT 500 mg tablet was first listed on the ARTG on 2 February 2011 (ARTG 164417) under licence category RE. A subsequent variant, MOFIT 500 mg film coated tablet, was listed on 22 April 2022 (ARTG 363771) under licence category RE.