ALCEPT

What it is

ALCEPT contains mycophenolate mofetil (MMF), with available strengths of 250 mg capsules and 500 mg tablets .

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 ALCEPT 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 contraception.** ALCEPT is contraindicated during pregnancy and in women of childbearing potential not using highly effective contraceptive methods due to its mutagenic and teratogenic potential. MMF 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 exposure, compared to 12% to 33% in solid organ transplant patients treated with other immunosuppressants. Congenital malformations have been reported in 23% to 27% of live births in MMF exposed pregnancies, compared to approximately 2% of live births in the overall population and 4% to 5% 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 MMF. Men should not donate semen during therapy and for 90 days following discontinuation of MMF. **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, 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 MMF in patients post-renal transplant, and this infection can be associated with serious outcomes, sometimes leading to renal graft loss. **Malignancy.** Patients receiving ALCEPT 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. **Blood disorders.** Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MMF in combination with other immunosuppressive agents, with the mechanism unknown and in some cases PRCA being found to be reversible with dose reduction or cessation of therapy. If neutropenia develops (Absolute Neutrophil Count (ANC) < 1.3 x 10⁹/L), dosing with ALCEPT should be interrupted or the dose reduced and the patient carefully observed. **Gastrointestinal complications.** 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. Gastrointestinal tract bleeding (requiring hospitalisation) has been observed in approximately 1.4% of patients treated with MMF 2 g in renal transplantation, 2.8% of patients receiving 3 g in cardiac transplantation and in 5.4% of patients receiving MMF 3 g in hepatic transplantation.

Contraindications

ALCEPT 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. ALCEPT is contraindicated in women who are breastfeeding.

Regulatory history

ALCEPT 250 mg capsules were first listed on the ARTG on 21 November 2011 (ARTG 173660), ALCEPT 500 mg film coated tablets on 22 April 2022 (ARTG 363770), and ALCEPT mycophenolate mofetil 1 g/5 ml powder for oral suspension on 19 October 2022 (ARTG 363231).