Summary of the safety profile:
In four clinical studies including 532 patients who received IKERVIS and 398 who received an IKERVIS vehicle (control), IKERVIS was administered at least once a day in both eyes, for up to one year. The most common adverse reactions were eye pain (19%), eye irritation (17.8%), lacrimation (6.2%), ocular hyperaemia (5.5%) and eyelid erythema (1.7%) which were usually transitory and occurred during instillation.
The majority of adverse reactions reported in clinical studies with the use of IKERVIS were ocular, and mild to moderate in severity.
Tabulated list of adverse reactions:
The following adverse reactions listed below were observed in clinical studies. They are ranked according to system organ class and classified according to the following convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data). (See Table.)
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Description of selected adverse reactions:
Instillation site pain was a frequently reported local adverse reaction associated with the use of IKERVIS during clinical trials. It is likely to be attributable to ciclosporin.
One case of severe epithelial erosion of the cornea identified as corneal decompensation by the investigator resolved without sequeleae was reported.
Patients receiving immunosuppressive therapies, including ciclosporin, are at increased risk of infections.
Both generalised and localised infections can occur. Pre-existing infections may also be aggravated.
Cases of infections have been reported uncommonly in association with the use of IKERVIS.