Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Ocular or peri-ocular malignancies or premalignant conditions
Active or suspected ocular or peri-ocular infection.
Patients wearing contact lenses have not been studied. Therefore, the use of Verkazia with contact lenses is not recommended.
Co-administration of Verkazia with eye drops containing corticosteroids may potentiate the effects of Verkazia on the immune system. However, in clinical studies, 18 patients received Verkazia (4 times daily) in co-administration with 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 Verkazia. (see section 4.5).
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 Verkazia is used for more than 12 months.
Verkazia 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.
Verkazia contains cetalkonium chloride which may cause eye irritation.
Efficacy and safety of Verkazia have not been studied beyond 12 months. Therefore, regular examination of the eye(s) is recommended, e.g. every 3 to 6 months, when Verkazia is used for more than 12 months.
No interaction studies have been performed with Verkazia.
Co-administration of Verkazia with eye drops containing corticosteroids may potentiate the effects of Verkazia on the immune system. However, in clinical studies, 18 patients received Verkazia (4 times daily) in co-administration with eye drops containing corticosteroids and no increase of the risk of adverse reactions related to the immune system were identified. (see section 4.4).
Verkazia is not recommended in women of childbearing potential not using effective contraception.
There are no data from the use of Verkazia in pregnant women.
Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of Verkazia. Verkazia is not recommended during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
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 Verkazia therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
There are no data on the effects of Verkazia on human fertility.
No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section 5.3).
Verkazia 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.
The most common adverse reactions in the clinicial trials with Verkazia were eye pain (11%) and eye pruritus (9%) which were usually transitory and occurred during instillation.
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).
| MedDRA system organ class | MedDRA frequency | Adverse reaction |
|---|---|---|
| Infections and infestations | Common | Upper respiratory tract infection. |
| Uncommon | Keratitis bacterial, herpes zoster ophthalmic. | |
| Nervous system disorders | Common | Headache. |
| Eye disorders | Very common | Eye pain. |
| Common | Eye pruritus, ocular hyperaemia, eye irritation, ocular discomfort, foreign body sensation in eyes, lacrimation increased, vision blurred, erythema of eyelid, eyelid oedema. | |
| Uncommon | Blepharitis, conjunctival oedema. | |
| Respiratory, thoracic and mediastinal disorders | Common | Cough. |
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.
Not applicable.
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