Ikervis Special Precautions

IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients.
Treatment of severe keratitis in dry eye disease: 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.
Treatment of severe VKC: Contact lenses: Patients wearing contact lenses have not been studied. Therefore, the use of IKERVIS with contact lenses is not recommended.
Concomitant therapy: Co-administration of IKERVIS with eye drops containing corticosteroids may potentiate the effects of IKERVIS on the immune system. However, in clinical studies, 18 patients received 4 times daily doses with co-administration of eye drops containing corticosteroids and no increase in the risk of adverse reactions related to the immune system was identified. Therefore, caution should be exercised when corticosteroids are administered concomitantly with IKERVIS.
Effects on the immune system: Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies. Therefore, regular examination of the eye(s) is recommended, e.g. every 3 to 6 months, when IKERVIS is used for more than 12 months.
IKERVIS has not been studied in patients with an active orofacial herpes simplex infection, a history of ocular herpes, varicella-zoster, or vaccinia virus infection and should therefore be used with caution in such patients.
Treatment duration: Efficacy and safety of Ikervis have not been studied beyond 12 months. Therefore, regular examination of the eye(s) is recommended, e.g. every 3 to 6 months, when used for more than 12 months.
Excipient: IKERVIS contains cetalkonium chloride which may cause eye irritation.
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. Patients should be advised not to drive or use machines until their vision has cleared.