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Ikervis is a brand name for Cyclosporine (also known as Ciclosporin). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 4.1 Therapeutic indication Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology The recommended dose is one drop once daily to be applied to the affected eye(s) at bedtime. Response to treatment should be reassessed at least every 6 months.
If a dose is missed, treatment should be continued on the next day as normal. Patients should be advised not to instil more than one drop in the affected eye(s). Special populations Elderly patients The elderly population has been studied in clinical studies.
No dose adjustment is required. Patients with renal or hepatic impairment The effect of ciclosporin has not been studied in patients with hepatic or renal impairment. However, no special considerations are needed in these populations.
3 Paediatric population There is no relevant use of ciclosporin in children and adolescents aged below 18 in the treatment of severe keratitis in patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Method of administration Ocular use. Precautions to be taken before administering the medicinal product Patients should be instructed to first wash their hands. Prior to administration, the single-dose container should be gently shaken.
For single use only. Each single-dose container is sufficient to treat both eyes. Any unused emulsion should be discarded immediately. Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after instillation, to reduce the systemic absorption.
This may result in a decrease in systemic undesirable effects and an increase in local activity. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart.
4).
These adverse reactions are consistent with those that have been reported during post-marketing experience. Tabulated list of adverse reactions The following adverse reactions listed below 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).
System Organ Class Frequency Adverse reactions Infections and infestations Uncommon Keratitis bacterial, Herpes zoster ophthalmic. Eye disorders Very common Eye pain, Eye irritation Common Erythema of eyelid, Lacrimation increased, Ocular hyperaemia, Vision blurred, Eyelid oedema, Conjunctival hyperaemia, Eye pruritus Uncommon Conjunctival oedema, Lacrimal disorder, Eye discharge, Conjunctival irritation, Conjunctivitis, Foreign body sensation in eyes, Deposit eye, Keratitis, Blepharitis, Chalazion, Corneal infiltrates, Corneal scar, Eyelid pruritus, Iridocyclitis.
Ocular discomfort General disorders and administration site conditions Uncommon Instillation site reaction Nervous system disorders Uncommon Headache 6 Description 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.
3). Cases of infections have been reported uncommonly in association with the use of IKERVIS. 2). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients. Contact lenses Patients wearing contact lenses have not been studied. Careful monitoring of patients with severe keratitis is recommended.
Contact lenses should be removed before instillation of the eye drops at bedtime and may be reinserted at wake-up time. Concomitant therapy There is limited experience with ciclosporin in the treatment of patients with glaucoma. Regular clinical monitoring should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers which are known to decrease tear secretion.
Effects on the immune system Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies. g. at least every 6 months, when IKERVIS is used for years.
Cetalkonium chloride content IKERVIS contains cetalkonium chloride. Contact lenses should be removed prior to application and may be reinserted at wake-up time. Cetalkonium chloride may cause eye irritation. Patients should be monitored in case of prolonged use.
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1. Ocular or peri-ocular malignancies or premalignant conditions. Active or suspected ocular or peri-ocular infection.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cyclosporine in European Union.
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It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.