CEPTOLATE

What it is

Mycophenolate mofetil (MMF) is the active ingredient in CEPTOLATE. CEPTOLATE is available in two strengths: 250 mg capsules and 500 mg tablets. The 250 mg capsules have a blue opaque cap with orange opaque body, containing white to off-white coloured powder, while the 500 mg tablets are capsule-shaped, lavender coloured, film-coated biconvex 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 CEPTOLATE 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

Patients receiving CEPTOLATE as part of an immunosuppressive regime are at an 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 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. Over suppression of the immune system can increase susceptibility to infection, including opportunistic infections, fatal infections and sepsis. Cases of Progressive Multifocal Leukoencephalopathy (PML) associated with the JC virus, sometimes fatal, have been reported in patients treated with MMF. Hemiparesis, apathy, confusion, cognitive deficiencies and ataxia were the most frequent clinical features observed. BK virus-associated nephropathy has been observed during the use of MMF in patients post-renal transplant. This infection can be associated with serious outcomes, sometimes leading to renal graft loss. Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MMF in combination with other immunosuppressive agents. The mechanism for MMF-induced PRCA is unknown; the relative contribution of other immunosuppressants and their combinations in an immunosuppression regimen are also unknown. If neutropenia develops (Absolute Neutrophil Count less than 1.3 × 10⁹/L), dosing with CEPTOLATE should be interrupted or the dose reduced and the patient carefully observed. CEPTOLATE 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. 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.

Contraindications

CEPTOLATE 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. CEPTOLATE is contraindicated during pregnancy due to its mutagenic and teratogenic potential. CEPTOLATE is contraindicated in women of childbearing potential not using highly effective contraceptive methods. CEPTOLATE is contraindicated in women who are breastfeeding.

Regulatory history

CEPTOLATE was first registered on the ARTG on 23 September 2011, with two registered variants: mycophenolate mofetil 250 mg capsules (ARTG 165766) and 500 mg tablets (ARTG 163308).