IKERVIS Eye drops, emulsion Ref.[6693] Active ingredients: Ciclosporin

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: SANTEN Oy, Niittyhaankatu 20, 33720, Tampere, Finland

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Active or suspected ocular or peri-ocular infection.

Special warnings and precautions for use

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 IKERVIS in the treatment of patients with glaucoma. Caution 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

Medicinal products, which affect the immune system, including ciclosporin, may affect host defences against infections and malignancies. Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of IKERVIS on the immune system (see section 4.5).

Excipient

IKERVIS contains cetalkonium chloride which may cause eye irritation.

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with IKERVIS.

Combination with other medicinal products that affect the immune system

Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of ciclosporin on the immune system (see section 4.4).

Fertility, pregnancy and lactation

Women of childbearing potential/contraception in females

IKERVIS is not recommended in women of childbearing potential not using effective contraception.

Pregnancy

There is no data from the use of IKERVIS in pregnant women.

Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of IKERVIS.

IKERVIS is not recommended during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.

Breast-feeding

Following oral administration, ciclosporin is excreted in breast milk. There is insufficient information on the effects of ciclosporin in newborns/infants. However, at therapeutic doses of ciclosporin in eye drops, it is unlikely that sufficient amounts would be present in breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IKERVIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There is no data on the effects of IKERVIS on human fertility.

No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section 5.3).

Effects on ability to drive and use machines

IKERVIS has moderate influence on the ability to drive and use machines.

This medicinal product may induce temporary blurred vision or other visual disturbances which may affect the ability to drive or use machines (see section 4.8). Patients should be advised not to drive or use machines until their vision has cleared.

Undesirable effects

Summary of the safety profile

In five clinical studies including 532 patients who received IKERVIS and 398 who received 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 (19.2%), eye irritation (17.8%), lacrimation (6.4%), 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 (1/1,000 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).

Infections and infestations

Uncommon: Keratitis bacterial, herpes zoster ophthalmic.

Eye disorders

Common: Erythema of eyelid, lacrimation increased, ocular hyperaemia, vision blurred, eyelid oedema, conjunctival hyperaemia, eye irritation, eye pain.

Uncommon: Conjunctival oedema, lacrimal disorder, eye discharge, eye pruritus, conjunctival irritation, conjunctivitis, foreign body sensation in eyes, deposit eye, keratitis, blepharitis, corneal decompensation, chalazion, corneal infiltrates, corneal scar, eyelid pruritus, iridocyclitis.

General disorders and administration site conditions

Very common: Instillation site pain.

Common: Instillation site irritation, instillation site erythema, instillation site lacrimation.

Uncommon: Instillation site reaction, instillation site discomfort, instillation site pruritus, instillation site foreign body sensation.

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 (see section 4.3). Cases of infections have been reported uncommonly in association with the use of IKERVIS. To reduce the systemic absorption, see section 4.2.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. 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.

Incompatibilities

Not applicable.

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