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Tabulated list of adverse reactions: The following adverse reactions listed as follows were observed in clinical studies or during post-marketing experience. 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 (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). (See Table 1.)
Click on icon to see table/diagram/imageTREATMENT OF SEVERE VKC: Summary of the safety profile: The most common adverse reactions in the clinical trials with ciclosporin were eye pain (11%) and eye pruritus (9%) which were usually transitory and occurred during instillation.
Tabulated list of adverse reactions: The following adverse reactions listed as follows 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 (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). (See Table 2.)
Click on icon to see table/diagram/imageDescription of selected adverse reactions: Eye pain: A frequently reported local adverse reaction associated with the use of IKERVIS during clinical trials. It is likely to be attributable to ciclosporin.
Generalised and localised infections: 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 (see Contraindications). Cases of infections have been reported uncommonly in association with the use of IKERVIS. As precautionary measure, action should be taken to reduce the systemic absorption (see Dosage & Administration).
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