Roclanda · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-099169 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most common adverse reactions observed in the clinical studies were conjunctival hyperaemia (46% of patients), eye pain (16%), 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, Dizziness Eye disorders Very Conjunctival hyperaemia1, common Cornea verticillata1, 5 System organ classification Frequency Adverse reactions Eye 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,

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HOS-099165 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

HOS-099164 · has-indication-information · PDF-Seite 2

Roclanda is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.

HOS-099167 · has-interaction-information · PDF-Seite 4

In vitro interaction studies have shown that precipitation can occur when eye drops containing thiomersal are mixed with latanoprost + netarsudil. Administer other eye drops at least five minutes apart (see section 4.2). In vitro studies have indicated netarsudil has the potential to inhibit CYP450 isoenzymes in the cornea, however no clinical evidence of local pharmacokinetic interactions has been observed to date. There have been reports of paradoxical elevations in IOP following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, the use of two or more prostaglandins, prostaglandin analogues or prostaglandin derivatives is not recommended.

HOS-099168 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no or limited amount of data from the use of latanoprost + netarsudil in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to netarsudil is negligible (see section 5.2). Animal studies with intravenous administration of netarsudil do not indicate direct or 4 indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3). Latanoprost has potentially harmful pharmacological effects during pregnancy and/or on the foetus/newborn child (see section 5.3). Therefore, latanoprost + netarsudil should not be used during pregnancy. Breast-feeding It is unknown whether netarsudil/metabolites are excreted in human milk. However, while no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding women to netarsudil is expected to be negligible, no relevant clinical data are available (see section 5.2). Latanoprost and its metabolites may pass into human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Roclanda therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility There are no data on the effects of netarsudil on male or female fertility. However, no effects are anticipated, since systemic exposure to netarsudil is negligible (see section 5.2). Latanoprost has not been found to have any effect on male or female fertility in animal studies (see section 5.3).

HOS-099166 · has-warning-information · PDF-Seite 3

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. 3 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 medi

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