MYCOPHENOLATE

What it is

Mycophenolate Sandoz contains mycophenolate mofetil, with each 250 mg capsule containing 250 mg of the active ingredient. The 500 mg tablet formulation contains 500 mg mycophenolate mofetil. Mycophenolate Sandoz is administered orally and may be given in combination with ciclosporin and corticosteroids.

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 Mycophenolate Sandoz 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.

Key safety warnings

**Pregnancy and reproductive potential.** Mycophenolate Sandoz is contraindicated during pregnancy due to its mutagenic and teratogenic potential. Mycophenolate mofetil is a human teratogen with an increased risk of spontaneous abortions (mainly in the first trimester) and congenital malformations in case of maternal exposure during pregnancy, with the risk of spontaneous abortions reported as 45% to 49% following mycophenolate mofetil exposure compared to a reported rate between 12% and 33% in solid organ transplant patients treated with other immunosuppressants. Female patients of childbearing potential must use effective contraception before, during and for six weeks after receiving mycophenolate mofetil. Men should not donate semen during therapy and for 90 days following discontinuation of mycophenolate mofetil. **Malignancy.** Patients receiving mycophenolate mofetil 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. **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 associated with the JC virus, sometimes fatal, have been reported in patients treated with mycophenolate mofetil, with hemiparesis, apathy, confusion, cognitive deficiencies and ataxia being the most frequent clinical features observed. BK virus-associated nephropathy has been observed during the use of mycophenolate mofetil in patients post-renal transplant, and this infection can be associated with serious outcomes, sometimes leading to renal graft loss. **Blood disorders.** Cases of pure red cell aplasia have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents, and in some cases this was found to be reversible with dose reduction or cessation of mycophenolate mofetil therapy. If neutropenia develops (Absolute Neutrophil Count < 1.3 x 10⁹/L), dosing with Mycophenolate Sandoz should be interrupted or the dose reduced and the patient carefully observed. **Gastrointestinal complications.** Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including uncommon cases of gastrointestinal tract ulceration, haemorrhage, and perforation, with gastrointestinal tract bleeding requiring hospitalisation observed in approximately 1.4% of patients treated with mycophenolate mofetil 2 g in renal transplantation, 2.8% of patients receiving 3 g in cardiac transplantation and 5.4% of patients receiving mycophenolate mofetil 3 g in hepatic transplantation.

Contraindications

Mycophenolate Sandoz is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil, to mycophenolic acid or any component of the capsules and tablets. Mycophenolate Sandoz is contraindicated in women of childbearing potential not using highly effective contraceptive methods. Mycophenolate Sandoz is contraindicated in women who are breastfeeding.

Regulatory history

Mycophenolate GH (500 mg tablet) sponsored by Accord Healthcare was first listed on the ARTG on 8 October 2019. Mycophenolate Accord (500 mg powder for injection) was first listed on the ARTG on 18 May 2021.