RHOKIINSA

Treatment with Rhokiinsa should only be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology The recommended dose is one drop in the affected eye(s) once daily in the evening. Patients should not instill more than one drop in the affected eye(s) each day.

If one dose is missed, treatment should continue with the next dose in the evening. Paediatric population The safety and efficacy of Rhokiinsa in children below the age of 18 years have not been established. No data are available. Method of administration For ocular use.

5). If netarsudil is to be used concomitantly with other topical ophthalmic medicinal products, each medicinal product should be administered at least five (5) minutes apart. Due to netarsudil’s vasodilating properties, other eye drops should be administered before.

Eye ointments should be administered last. 4). The tip of the dispensing container should avoid contacting the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Summary of the safety profile The most common adverse reactions observed in the clinical trials were conjunctival hyperemia (51% of patients), cornea verticillata (17%), instillation site pain (17%), conjunctival haemorrhage (8%), instillation site erythema (8%), corneal staining (7%), blurred vision (6%), increased lacrimation (6%) and erythema of eyelid (5%).

Serious adverse reactions were not reported in clinical trials. Tabulated list of adverse reactions The following adverse reactions have been reported with netarsudil, dosed once daily. Reactions are classified according to the 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).

System organ classification Frequency Adverse reactions Immune system disorders Uncommon Hypersensitivity Nervous system disorders Common Headache Uncommon Dizziness Eye disorders Very common Conjunctival hyperaemia1, Cornea verticillata1, Instillation site pain Common Conjunctival haemorrhage, Vision blurred, Lacrimation increased, Erythema of eyelid, Eye pruritis, Eye irritation, Visual acuity reduced, Eyelid oedema, Punctate keratitis, Conjunctival oedema, Foreign body sensation in eyes, Conjunctivitis, Conjunctivitis allergic, Photophobia, Eyelid pruritus, Eye pain, Corneal opacity, Dry eye, Eye discharge, Instillation site erythema, Instillation site discomfort, Instillation site pruritis, Vital dye staining cornea present, Intraocular pressure increased Uncommon Ocular hyperaemia, Blepharitis, Corneal disorder, Eyelid margin crusting, Eye allergy, Conjunctival follicles, Ocular discomfort, Eye swelling, Corneal deposits, Eyelid disorder, Meibomian gland dysfuntion, Corneal pigmentation, Diplopia, Ectropion, Lenticular opacities, Noninfective conjunctivitis, Abnormal sensation in the eye, Asthenopia, Episcleral hyperaemia, Halo vision, Keratitis, Refraction disorder, Anterior chamber flare, Anterior chamber inflammation, Blindness, System organ classification Frequency Adverse reactions Conjunctival irritation, Conjunctivochalasis, Diabetic retinopathy, Eczema eyelids, Eyelid skin dryness, Glaucoma, Growth of eyelashes, Iris adhesions, Iris bombe, Iritis, Ocular hypertension, Visual impairment, Corneal dystrophy, Instillation site foreign body sensation, Instillation site irritation, Glassy eyes, Fatigue, Instillation site dryness, Instillation site oedema, Instillation site paraesthesia, Conjunctival staining, Optic nerve cup/disc ratio increased, Madarosis Visual field defect Not known Reticular epithelial corneal oedema2 Respiratory, thoracic and mediastinal disorders Uncommon Nasal discomfort, Rhinalgia Skin and subcutaneous tissue disorders Uncommon Dermatitis allergic, Dermatitis contact, Lichenification, Petechiae Musculoskeletal and connective tissue disorders Uncommon Polychondritis Injury, poisoning and procedural complications Uncommon Excoriation 1 See Description of selected adverse reactions for further information 2 Additional adverse reaction observed with netarsudil monotherapy Description of selected adverse reactions Conjunctival hyperaemia Conjunctival hyperaemia was the most frequently reported adverse reaction associated with netarsudil treatment in clinical trials and it is attributed to the vasodilation effect of the Rho kinase inhibitor drug class.

Ocular effects Twice a day dosing is not well tolerated and is not recommended. Netarsudil dosed twice daily provided slightly larger IOP reductions, but had a less favorable safety profile as reflected in a higher rate and increased severity of ocular adverse reactions.

8%) during a 12-month study. It is therefore recommended to dose netarsudil once daily. Reticular epithelial corneal oedema Reticular epithelial corneal oedema (RECE) has been reported following administration of medicinal products containing netarsudil, particularly in patients with preexisting corneal oedema or prior ocular surgery.

RECE typically resolves upon discontinuation of the medicinal product containing netarsudil. Patients should be advised to notify their physician if they experience decreased vision or eye pain while using Rhokiinsa. The efficacy of netarsudil has not been studied beyond 12 months.

Excipients with known effect Benzalkonium chloride This medicinal product contains benzalkonium chloride. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface and is known to discolour soft contact lenses.

It should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

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