CERTICAN

What it is

Certican is a registered Australian medicine containing everolimus as its active ingredient, available in tablet strengths of 0.25 mg, 0.50 mg, 0.75 mg, and 1.0 mg, and in dispersible tablet strengths of 0.10 mg and 0.25 mg.

Approved indications

— Prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic renal transplant. — Prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic cardiac transplant. — Prophylaxis of organ rejection in adult patients receiving an allogeneic hepatic transplant.

Dosing overview

For kidney and heart transplantation, an initial dose regimen of 0.75 mg twice a day is recommended for the general population, administered as soon as possible after transplantation. For liver transplantation, the dose of 1.0 mg twice a day is recommended, with the initial dose approximately 4 weeks after transplantation. The daily dose should always be given orally in two divided doses, consistently either with or without food and at the same time as cyclosporin microemulsion or tacrolimus.

Key safety warnings

Patients on a regimen of immunosuppressive medicinal products, including Certican, are at increased risk of developing infections especially with opportunistic pathogens (bacterial, fungal, viral, protozoal), and fatal infections and sepsis have been reported in patients treated with Certican. Among opportunistic conditions to which immunosuppressed patients may be vulnerable are polyomavirus infections including BK virus-associated nephropathy which can lead to kidney graft loss and potentially fatal JC virus-associated progressive multiple leukoencephalopathy (PML), and these infections should be considered in the differential diagnosis of immunosuppressed patients with deteriorating kidney graft function or neurological symptoms. Patients receiving a regimen of immunosuppressive drugs, including Certican, are at increased risk of developing lymphomas or other malignancies, particularly of the skin, and the absolute risk seems related to the duration and intensity of immunosuppression rather than to the use of a specific agent; patients should be monitored regularly for skin neoplasms and advised to minimise exposure to UV light, sunlight and use appropriate sunscreen. In renal and cardiac transplant, Certican may potentiate the renal toxicity of cyclosporin, and Certican with full-dose cyclosporin increases the risk of renal dysfunction, requiring reduced doses of cyclosporin for use in combination with Certican in order to avoid renal dysfunction. Cases of interstitial lung disease, implying lung intraparenchymal inflammation (pneumonitis) and/or fibrosis of non-infectious etiology, some fatal, have occurred in patients receiving rapamycins and their derivatives, including Certican; mostly, the condition resolves after discontinuation of Certican and/or addition of glucocorticoids, however, fatal cases have also occurred. Certican has been shown to increase the risk of new onset diabetes mellitus after transplant, and blood glucose concentrations should be monitored closely in patients treated with Certican.

Contraindications

Certican is contraindicated in patients with a known hypersensitivity to everolimus, sirolimus or to any of the excipients.

PBS listing

The available source documents do not contain information about the current PBS listing, item number, restriction type, or ex-manufacturer price for Certican in its transplant indications.

Regulatory history

Certican was first registered on the Australian Register of Therapeutic Goods on 17 March 2005, with six product registrations covering tablet and dispersible tablet formulations in strengths of 0.1 mg, 0.25 mg, 0.5 mg, 0.75 mg, and 1.0 mg.