MYCOFOR

What it is

MYCOFOR is mycophenolate sodium supplied as enteric coated 360 mg tablets containing mycophenolic acid 360 mg. The tablets are pale orange-red, oval shaped and biconvex, imprinted "MA 360".

Approved indications

— Prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants. — Induction and maintenance treatment of adult patients with WHO Class III, IV or V lupus nephritis.

Dosing overview

For renal transplant patients, MYCOFOR should be initiated within 48 hours following transplantation at a recommended dose of 720 mg administered twice daily (1440 mg daily dose). For lupus nephritis patients, adequate dose-finding studies have not been performed and the prescriber should adjust the dose based on clinical response; the recommended dose is 720 mg administered twice daily (1440 mg daily dose). A daily dose greater than 1440 mg per day has been used for induction therapy in some studies and may be tapered for maintenance purposes following a complete or partial response. MYCOFOR tablets should not be crushed and should be swallowed whole. Patients should be advised to take MYCOFOR consistently either with or without food, but not switch between fed and fasted states.

Key safety warnings

MYCOFOR can cause foetal harm when administered to a pregnant woman, with an increased risk of pregnancy loss including spontaneous abortion and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, oesophagus and kidney. Patients receiving immunosuppressive regimens involving combinations of drugs, including MYCOFOR, are at 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 to the use of any specific agent, and exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor. Oversuppression of the immune system increases the susceptibility to infection, including opportunistic infections, fatal infections and sepsis. Reactivation of hepatitis B or hepatitis C have been reported in patients treated with immunosuppressants, including mycophenolate sodium, and monitoring infected patients for clinical and laboratory signs of active infection is recommended. Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with mycophenolate sodium, with hemiparesis, apathy, confusion, cognitive deficiencies and ataxia being the most frequent clinical features observed. Patients taking MYCOFOR should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year; if blood dyscrasias occur such as neutropenia with absolute neutrophil count less than 1.5 × 10⁹/L or anaemia, it may be appropriate to interrupt or discontinue MYCOFOR.

Contraindications

MYCOFOR is contraindicated in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection. MYCOFOR is contraindicated in women who are breast-feeding and in women of child-bearing potential who are not using highly effective contraception methods. MYCOFOR is also contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid or mycophenolate mofetil or to any of the excipients of the formulation.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

MYCOFOR (mycophenolic acid as sodium 360 mg enteric coated tablet) was first listed on the ARTG on 18 September 2023.