IKERVIS EYE DROPS, EMULSION 1MG/ML [SIN15216P]

Product Info

IKERVIS EYE DROPS, EMULSION 1MG/ML

[SIN15216P]

4.1 Therapeutic indication

Treatment of severe keratitis in dry eye disease
Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Treatment of severe vernal keratoconjunctivitis (VKC)
Treatment of severe vernal keratoconjunctivitis (VKC) in children and adolescents from 4 to 18 years old (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

IKERVIS treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.

Posology
Treatment of severe keratitis in dry eye disease
Adults
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.

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).

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 IKERVIS has not been studied in patients with hepatic or renal impairment. However, no special considerations are needed in these populations.

Paediatric population
There is no relevant use of IKERVIS 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.

Treatment of severe VKC
Children from 4 years of age and adolescents
The recommended dose is one drop of IKERVIS 4 times a day (morning, noon, afternoon and evening) to be applied to each affected eye during the VKC season. If signs and symptoms of VKC persist after the end of the season, the treatment can be maintained at the recommended dose or decreased to one drop twice daily once adequate control of signs and symptoms is achieved. Treatment should be discontinued after signs and symptoms are resolved, and reinitiated upon their recurrence.

Efficacy and safety of IKERVIS in VKC has not been studied beyond 12 months. (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If a dose is missed, treatment should be continued on the next instillation as normal. Patients should be advised not to instill more than one drop for each instillation in the affected eye(s).

Children below 4 years
There is no relevant use of IKERVIS in the treatment of VKC in children below 4 years.

Adults
The effect of IKERVIS in VKC has not been studied in patients above 18 years of age.

Patients with renal or hepatic impairment
The effect of IKERVIS in VKC has not been studied in patients with renal or hepatic impairment. However, no special dose adjustment is needed in these populations.

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 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart. IKERVIS should be administered last (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Active or suspected ocular or peri-ocular infection.
Patients with ocular or peri-ocular malignancies or premalignant conditions.