EYLEA

Eylea must only be administered by a qualified healthcare professional experienced in intravitreal injections. 07 ml solution. The posology is the same for the nAMD and DMO indications. 3 mg/ml. For patients who are initiating treatment, Eylea is administered with 1 injection per month for 3 consecutive doses.

Injection intervals may then be extended up to every 4 months based on the physician’s judgement of visual and/or anatomic outcomes. 1). 3 mg/ml, the treatment regimen can differ from that used for treatment-naïve patients. 1). 3 mg/ml, such as with a treat-and-extend dosing regimen.

3 mg/ml may begin with 1 injection per month for up to 3 consecutive doses followed by adjustment of injection intervals, such as with a treat-and-extend dosing regimen. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly based on the physician’s discretion.

The interval between 2 injections should not be shorter than 1 month. 3 mg/ml should be discontinued. Eylea at monthly doses of 8 mg has not been studied for more than 3 consecutive doses in the PULSAR (nAMD) and PHOTON (DMO) studies.

Available data support the administration of more than 3 consecutive monthly doses for certain patients, however the data are currently limited. The frequency of monitoring visits should be based on the patient’s status and at the physician’s discretion.

For events in which treatment should be withheld see section

4%). 8%). 3 mg/ml (N=1 808) and Eylea 40 mg/ml (N=857), and in patients with nAMD, DMO and RVO. 3 mg/ml up to 96 weeks constituted the safety population in 4 clinical phase II/III studies (CANDELA, PULSAR, PHOTON, QUASAR). The safety data described below include all adverse reactions with a reasonable possibility of causality to the injection procedure or medicinal product reported.

The adverse reactions are listed by system organ class and frequency using 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), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 3 mg/ml in phase II/III studies or during post marketing surveillance System organ class Frequency Adverse reaction Immune system disorders Common Hypersensitivity* Common Cataract, Intraocular pressure increased, Vitreous floaters, Vitreous detachment, Vitreous haemorrhage, Retinal haemorrhage, Visual acuity reduced, Eye pain, Conjunctival haemorrhage, Punctate keratitis, Corneal abrasion Eye disorders Uncommon Retinal detachment, Retinal tear, Retinal pigment epithelial tear, Detachment of the retinal pigment epithelium, Uveitis, Iritis, Iridocyclitis, Vitritis, Cataract cortical, Cataract nuclear, Cataract subcapsular, Corneal erosion, Vision blurred, Injection site pain, Foreign body sensation in eyes, Lacrimation increased, Injection site haemorrhage, Conjunctival hyperaemia, Lenticular opacities, Eyelid oedema, Ocular hyperaemia, Injection site irritation, Retinal degeneration, Corneal oedema Rare Blindness, Endophthalmitis, Eyelid irritation Not known Scleritis** * Reports of hypersensitivity included rash, pruritus, urticaria.

** From post marketing reporting. 3 mg/ml: abnormal sensation in eye, corneal epithelium defect, anterior chamber flare, traumatic cataract, hypopyon, severe anaphylactic/anaphylactoid reactions. Description of selected adverse reactions Product-class-related adverse reactions Arterial thromboembolic events (ATEs) are adverse reactions potentially related to systemic VEGF inhibition.

4. 07 ml solution. 3 mg/ml. For patients who are initiating treatment, Eylea is administered with 1 injection per month for 3 consecutive doses. 1). 3 mg/ml, the treatment regimen can differ from that used for treatment-naïve patients. 1).

3 mg/ml, such as with a treat-and-extend dosing regimen. 3 mg/ml may begin with 1 injection per month for up to 3 consecutive doses followed by adjustment of injection intervals, such as with a treat-and-extend dosing regimen. 1). The interval between 2 injections should not be shorter than 1 month.

3 mg/ml should be discontinued. The frequency of monitoring visits should be based on the patient’s status and at the physician’s discretion. 4. Special populations Renal or hepatic impairment No specific studies in patients with renal or hepatic impairment have been conducted.

2). Elderly Available data do not suggest a need for a dose adjustment with Eylea in these patients. 3 mg/ml in children and adolescents below 18 years have not been established. 3 mg/ml in the paediatric population in the nAMD, DMO and RVO indications.

Method of administration Eylea is for intravitreal injection only. Intravitreal injections must be carried out according to medical standards and applicable guidelines by a qualified healthcare professional experienced in administering intravitreal injections.

g. povidone iodine applied to the periocular skin, eyelid and ocular surface), have to be ensured. Surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent) are recommended. 0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.

07 ml is then delivered. A different scleral site should be used for subsequent injections. Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry.

1. - Ocular or periocular infection. - Active severe intraocular inflammation.