EYLEA® (Non-English)

Eylea is indicated for adults for the treatment of:

• Neovascular (wet) age-related macular degeneration (AMD)
• Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
• Visual impairment due to diabetic macular oedema (DME)
• Visual impairment due to myopic choroidal neovascularisation (myopic CNV)

EYLEA is indicated in preterm infants for the treatment of:

• Retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease.

EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema Following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)
• Retinopathy of Prematurity (ROP)

Eylea is a 40 mg/mL solution for injection in pre-filled syringe. 1 mL solution for injection contains 40 mg aflibercept. One pre-filled syringe contains an extractable volume of at least 0.09 mL, equivalent to at least 3.6 mg aflibercept. This provides a usable amount to deliver a single dose of 0.05 mL containing 2 mg aflibercept to adult patients or a single dose of 0.01 mL containing 0.4 mg aflibercept to preterm infants.

1. Preparation: The patient is seated comfortably. The eye area is cleaned and a solution may be used to numb the eye.
2. Anesthesia: An anesthetic injection may also be given near the eye to further numb it and reduce movement.
3. Speculum Insertion: A device called a lid speculum may be used to keep the eyelids open.
4. Injection: The healthcare provider will then inject the Eylea solution into the vitreous humor, which is the clear gel that fills the space between the lens and the retina of the eyeball.
5. Aftercare: Following the injection, the patient will need to have their eye monitored for potential side effects. They may be given antibiotic eye drops to prevent infection.

Contraindications

• Ocular or Periocular Infections: EYLEA is contraindicated in patients with ocular or periocular infections.
• Active Intraocular Inflammation: EYLEA is contraindicated in patients with active intraocular inflammation.
• Hypersensitivity: EYLEA is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in EYLEA. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation.

After-care

• In the days following EYLEA administration, patients are at risk of developing endophthalmitis, retinal detachment, or retinal vasculitis with or without occlusion. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients and/or caregivers to seek immediate care from an ophthalmologist.
• Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular endothelial growth factor (VEGF) inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
• Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations.
• Advise patients not to drive or use machinery until visual function has recovered sufficiently.