ROCLANDA

Treatment with Roclanda 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 instil 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 Roclanda in children below the age of 18 years have not been established. No data are available. Method of administration For ocular use.

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

Eye ointments should be administered last. 4). As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop.

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 studies were conjunctival hyperaemia (46% of patients), instillation site pain (14%), cornea verticillata (12%) and eye pruritis (7%). Serious adverse reactions were not reported in clinical studies.

Tabulated list of adverse reactions The following adverse reactions have been reported with latanoprost + netarsudil, dosed once daily, and during clinical studies and post-marketing surveillance with the individual components latanoprost and netarsudil.

Adverse reactions are presented according to the MedDRA system organ classification. Within each system organ class, the adverse reactions are classified by frequency 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).

System organ classification Frequency Adverse reactions Infections and infestations Rare Herpetic keratitis2 Immune system disorders Uncommon Hypersensitivity Nervous system disorders Uncommon Headache, Muscle contractions involuntary, Dizziness, Visual field defect3 Very common Conjunctival hyperaemia1, Cornea verticillata1, Instillation site pain, Iris hyperpigmentation2, Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation and number of eyelashes)2 Common Conjunctival haemorrhage, Vision blurred, Lacrimation increased, Erythema of eyelid, Eye pruritus, Eye irritation, Visual acuity reduced, Eyelid oedema, Punctate keratitis, Corneal disorder, Conjunctival oedema, Conjunctivitis allergic, Eye pain, Dry eye, Foreign body sensation in eyes, Eyelid margin crusting, Blepharitis, Instillation site erythema, Instillation site discomfort, Vital dye staining cornea present Eye disorders Uncommon Eyelids pruritus, Conjunctival disorder, Corneal opacity, Eye discharge, Corneal deposits, Conjunctivitis, Dacryostenosis acquired, Eye inflammation, Eye paraesthesia, Conjunctival follicles, Eye swelling, Meibomian gland dysfunction, Corneal pigmentation, Diplopia, Noninfective conjunctivitis, Abnormal sensation in eye, System organ classification Frequency Adverse reactions Keratitis, Refraction disorder, Anterior chamber flare, Conjunctival irritation, Intraocular pressure increased, Eyelid rash, Eyelid skin dryness, Growth of eyelashes, Lacrimal disorder, Iritis, Visual impairment, Corneal dystrophy, Instillation site dryness, Instillation site pruritus, Instillation site reaction, Eye complication associated with device, fatigue, Instillation site paraesthesia, Macular oedema including cystoid macular oedema2, Uveitis2 Ocular hyperaemia Diabetic retinopathy3, Eye allergy3 Ocular discomfort, Eyelid disorder3, Ectropion3, Lenticular opacities3, Asthenopia3, Episcleral hyperaemia3, Halo vision3, Anterior chamber inflammation3, Blindness3, Conjunctivochalasis, Eczema eyelids3, Glaucoma3, Iris adhesions3, Iris bombe3, Ocular hypertension3, Instillation site irritation3, Glassy eyes3, Instillation site oedema3, Conjunctival staining3, Optic nerve cup/disc ratio increased3, Madarosis3, Blepharal pigmentation, Eye disorder, Retinal haemorrhage, Photophobia Rare Corneal oedema2, Corneal erosion2, Periorbital oedema2, Trichiasis2, System organ classification Frequency Adverse reactions Distichiasis2, Iris cyst2, Localised skin reaction on the eyelids2, Darkening of the palpebral skin of the eyelids2, Pseudopemphigoid of ocular conjunctiva2 Very rare Periorbital and lid changes resulting in deepening of the eyelid sulcus2 Not known Reticular epithelial corneal oedema3 Uncommon Angina2, Palpitations2 Cardiac disorders Very rare Angina unstable2 Uncommon Epistaxis, Nasal congestion, Nasal discomfort3, Rhinalgia3 Asthma2, Dyspnoea2 Respiratory, thoracic and mediastinal disorders Rare Asthma exacerbation2 Gastrointestinal disorders Uncommon Nausea, Vomiting Common Dermatitis contact Uncommon Lichenification, Dry skin, Erythema, Skin disorder, Dermatitis allergic3 Petechiae, Eczema Skin and subcutaneous tissue disorders Rare Pruritus2 Musculoskeletal and connective tissue disorders Uncommon Pain in jaw, Myalgia2, Arthralgia2, Polychondritis3, Muscular weakness, Sjogren’s syndrome General disorders and administration site conditions Uncommon Chest pain2 Injury, poisoning and procedural complications Uncommon Excoriation3 1 See Description of selected adverse reactions for further information 2 Additional adverse reaction observed with latanoprost monotherapy 3 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 latanoprost + netarsudil treatment in clinical studies and it is attributed to the vasodilation effect of the Rho kinase inhibitor medicinal product class.

Conjunctival hyperaemia was typically mild in severity and sporadic. However, there was a relatively small proportion of subjects with moderate or severe hyperaemia who discontinued treatment because of this adverse reaction (5% in Phase 3 clinical studies).

Cornea verticillata Cornea verticillata occurred in approximately 13% of the patients in controlled Phase 3 clinical studies. The cornea verticillata seen in latanoprost + netarsudil- treated patients were first noted at 4 weeks of daily dosing.

This reaction did not result in any apparent visual functional changes in patients. The majority of cornea verticillata resolved upon discontinuation of treatment. 8 vs. 8 vs. 7 vs. 5%). Iris pigmentation Roclanda contains latanoprost which is a prostaglandin F2α analogue.

The majority of adverse reactions associated with latanoprost are […]

Iris pigmentation Latanoprost may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a permanent change in eye colour.

Unilateral treatment can result in permanent heterochromia. Increased iris pigmentation has not been shown to have any negative clinical sequelae and treatment with medicinal products containing latanoprost can be continued if iris pigmentation ensues.

However, patients should be monitored regularly and if the clinical situation warrants, treatment with medicinal products containing latanoprost may be discontinued. Herpetic keratitis condition Medicinal product(s) containing latanoprost should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues.

Macular oedema risk Reports of macular oedema with medicinal products containing latanoprost have occurred mainly in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema (such as diabetic retinopathy and retinal vein occlusion).

Medicinal products containing latanoprost should be used with caution in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.

Iritis/uveitis risk In patients with known predisposing risk factors for iritis/uveitis, medicinal products containing latanoprost can be used with caution. Asthma exacerbation There is limited experience of latanoprost use in patients with asthma, but some cases of exacerbation of asthma and/or dyspnoea were reported in post marketing experience.

Asthmatic patients should therefore be treated with caution until there is sufficient experience with the combination. Periorbital skin discolouration Periorbital skin discolouration has been observed on treatment with medicinal products containing latanoprost, the majority of reports being in Japanese patients.

Experience to date shows that periorbital skin discolouration is not permanent and in some cases has reversed while continuing treatment with latanoprost. Eyelash changes Treatment with medicinal products containing latanoprost may gradually change eyelashes and vellus hair in the treated eye and surrounding areas; these changes include increased length, thickness, pigmentation, number of lashes or hairs and misdirected growth of eyelashes.

Eyelash changes are reversible upon discontinuation of treatment. 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 Roclanda. The efficacy of Roclanda has not been studied beyond 12 months.

Excipient 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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