CELLCEPT

What it is

Mycophenolate Sandoz is a medicine containing mycophenolate mofetil (MMF). It is available as 250 mg capsules and 500 mg tablets. It is administered orally.

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 should be given as soon as clinically feasible following transplantation.

Key safety warnings

**Blood and immune system.** Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MMF in combination with other immunosuppressive agents, and in some cases PRCA was found to be reversible with dose reduction or cessation of MMF therapy. 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, with particular attention to monitoring for neutropenia. There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving MMF in combination with other immunosuppressants, and patients on MMF who develop recurrent infections should have their serum immunoglobulins measured. **Infections.** Over suppression of the immune system can increase susceptibility to infection, including opportunistic infections, fatal infections and sepsis. Infections include latent viral reactivation such as hepatitis B or hepatitis C reactivation, and cases of hepatitis due to reactivation of hepatitis B or hepatitis C have been reported in carrier patients treated with immunosuppressants. Cases of Progressive Multifocal Leukoencephalopathy (PML) associated with the JC virus, sometimes fatal, have been reported in patients treated with MMF, generally in those with concomitant immunosuppressant therapies and impaired immune function. BK virus-associated nephropathy has been observed during the use of MMF in patients post-renal transplant, and this infection can be associated with serious outcomes, sometimes leading to renal graft loss. **Neoplasms.** Patients receiving MMF as part of an immunosuppressive regime are at an 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 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. **Gastrointestinal.** MMF has been associated with an increased incidence of digestive system adverse events, including uncommon cases of gastrointestinal tract ulceration, haemorrhage, and perforation, and should be administered with caution in patients with active serious digestive system disease. **Pregnancy and lactation.** MMF is contraindicated during pregnancy due to its mutagenic and teratogenic potential. MMF is a human teratogen with an increased risk of spontaneous abortions (reported as 45% to 49% following MMF exposure) and congenital malformations in 23% to 27% of live births in MMF exposed pregnancies. Female patients of childbearing potential must use effective contraception before, during and for six weeks after receiving MMF.

Contraindications

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

Regulatory history

CELLCEPT mycophenolate mofetil 250 mg capsules were first listed on the ARTG on 2 November 1999. CELLCEPT mycophenolate mofetil 500 mg powder for injection was first listed on 7 February 2000. CELLCEPT mycophenolate mofetil 200 mg/mL suspension was first listed on 14 March 2000. CELLCEPT mycophenolate mofetil 500 mg tablets in a new formulation were first listed on 17 June 2002.