Rhokiinsa

HOS-098459 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile The most common adverse reactions observed in the clinical trials were conjunctival hyperemia (51% of patients), eye pain (21%), cornea verticillata (17%), conjunctival haemorrhage (9%), erythema of eyelid (15%), corneal staining (7%), blurred vision (6%) and increased lacrimation (6%) . 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 Conjunctival hyperaemia1, common Cornea verticillata1, Eye pain, Erythema of eyelid, Common Conjunctival haemorrhage, Vision blurred, Lacrimation increased, Eye pruritus, Eye irritation, Visual acuity reduced, Eyelid oedema, Punctate keratitis, Conjunctival oedema, Foreign body sensation in eyes, Conjunctivitis, Conjunctivitis allergic,

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098455 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

HOS-098454 · has-indication-information · PDF-Seite 2

Rhokiinsa is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.

HOS-098457 · has-interaction-information · PDF-Seite 3

No interaction studies have been performed.

HOS-098458 · has-pregnancy-information · PDF-Seite 3

Pregnancy There are no or limited amount of data from the use of 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 do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3). Rhokiinsa should not be used during pregnancy unless the clinical condition of the woman requires treatment with netarsudil. 3 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). A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Rhokiinsa 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).

HOS-098456 · has-warning-information · PDF-Seite 3

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. Twice a day dosing was also associated with a higher discontinuation rate due to adverse reactions (53.8%) 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.