MYCOTEX

What it is

MYCOTEX is mycophenolate sodium, supplied as 360 mg enteric coated tablets. The tablets are pale orange-red coloured, oval shaped, biconvex, film coated tablets 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, MYCOTEX should be initiated within 48 hours following transplantation, with a recommended dose of 720 mg administered twice daily (1440 mg daily dose). For lupus nephritis patients, the recommended dose is 720 mg administered twice daily (1440 mg daily dose). A daily dose of greater than 1440 mg/day has been used for induction therapy in some studies, and this dose may be tapered for maintenance purposes following a complete or partial response. MYCOTEX tablets should not be crushed and should be swallowed whole. Patients should be advised to take MYCOTEX consistently either with or without food, but not switch between fed and fasted states because of the risk of increased MPA AUC variability.

Key safety warnings

MYCOTEX 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 MYCOTEX, 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. To minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor. Patients receiving MYCOTEX should be instructed to immediately report any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression. Oversuppression of the immune system increases the susceptibility to infection, including opportunistic infections, fatal infections and sepsis. Reactivation of hepatitis B or hepatitis C has been reported in patients treated with immunosuppressants, including mycophenolate sodium. Monitoring infected patients for clinical and laboratory signs of active hepatitis B or hepatitis C infection is recommended. Cases of progressive multifocal leukoencephalopathy, sometimes fatal, have been reported in patients treated with mycophenolate sodium. Hemiparesis, apathy, confusion, cognitive deficiencies and ataxia were the most frequent clinical features observed. Polyomavirus associated nephropathy especially due to BK virus infection should be included in the differential diagnosis in immunosuppressed patients with deteriorating renal function. Consideration should be given to reducing the total immunosuppression in patients who develop progressive multifocal leukoencephalopathy or polyomavirus associated nephropathy. Patients taking MYCOTEX 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. Because mycophenolic acid derivatives have been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration and haemorrhage, and perforation, MYCOTEX should be administered with caution in patients with active serious digestive system disease.

Contraindications

MYCOTEX is contraindicated in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection, since it is associated with increased risks of pregnancy loss including spontaneous abortion and congenital malformations. MYCOTEX is contraindicated in women who are breast-feeding and in women of child-bearing potential who are not using highly effective contraception methods and should not be initiated without providing a pregnancy test to rule out unintended pregnancy. It 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 information regarding PBS listing for MYCOTEX is available in the provided source documents.

Regulatory history

MYCOTEX mycophenolic acid (as sodium) 360 mg enteric coated tablets were first listed on the ARTG on 18 September 2023 in both bottle pack and blister pack presentations.