IKERVIS

What it is

IKERVIS is ciclosporin 0.1% ophthalmic emulsion, with one mL containing 1 mg of ciclosporin. It is supplied as eye drops in the form of a milky white liquid emulsion. This medicinal product is subject to additional monitoring in Australia.

Approved indications

— Treatment of severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes.

Dosing overview

The recommended dose is one drop of IKERVIS once daily to be applied to the affected eye(s) at bedtime. Response to treatment should be reassessed at least every 6 months. Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after instillation, to reduce the systemic absorption.

Key safety warnings

Ophthalmic medicinal products which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies. Regular examination of the eye(s) is recommended, for example at least every 6 months. Patients receiving immunosuppressive therapies, including ciclosporin, are at increased risk of infections, both generalised and localised. The most common adverse reactions were eye pain (19.0%), eye irritation (17.5%), ocular hyperaemia (5.5%), lacrimation increased (4.9%) and eyelid erythema (1.7%), which are usually transitory and occurred during instillation. IKERVIS has moderate influence on the ability to drive and use machines, as this medicinal product may induce temporary blurred vision or other visual disturbances which may affect the ability to drive or use machines. IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients. There is limited experience with IKERVIS in the treatment of patients with glaucoma, and caution should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers, which are known to decrease tear secretion.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Ocular or peri-ocular malignancies or premalignant conditions. Active or suspected ocular or peri-ocular infection; treatment with IKERVIS should not be initiated or continued until all signs of infection have cleared.

PBS listing

IKERVIS eye drops 1 mg per mL in single dose units of 0.3 mL, pack of 30, is listed on the PBS with authority required restriction at an ex-manufacturer price of A$65.00.

Regulatory history

IKERVIS was registered on the ARTG on 15 December 2020. The Pharmaceutical Benefits Scheme Advisory Committee recommended listing in March 2021 for dry eye disease in patients with severe keratitis.