dling of the medicinal product, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1.
Active or suspected ocular or periocular infection.
Active severe intraocular inflammation.
4.4 Special warnings and precautions for use
Endophthalmitis
Intravitreal injections, including those with aflibercept, have been associated with endophthalmitis (see section 4.8). Proper aseptic injection techniques must always be used when administering Eylea. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay, and these should be managed appropriately.
Increase in intraocular pressure
Increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including those with Eylea (see section 4.8). Special precaution is needed in patients with poorly controlled glaucoma (do not inject Eylea while the intraocular pressure is ≥ 30 mmHg). In all cases, both the intraocular pressure and the perfusion of the optic nerve head must therefore be monitored and managed appropriately.
Immunogenicity
As this is a therapeutic protein, there is a potential for immunogenicity with Eylea (see section 4.8). Patients should be instructed to report any signs or symptoms of intraocular inflammation, e.g. pain, photophobia, or redness, which may be a clinical sign attributable to hypersensitivity.
Systemic effects
Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors, and there is a theoretical risk that these may relate to VEGF inhibition.
Other
As with other intravitreal anti-VEGF treatments for AMD and CRVO the following also applies:
• The safety and efficacy of Eylea therapy administered to both eyes concurrently have not been systematically studied.
• Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for wet AMD, include a large and/or high pigment epithelial retinal detachment. When initiating Eylea therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
• Treatment should be withheld in patients with rhegmatogenous retinal detachment or stage 3 or 4 macular holes.
• In the event of a retinal break the dose should be withheld and treatment should not be resumed until the break is adequately repaired.
• The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of:
• a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity;
• a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥50%, of the total lesion area.
• The dose should be withheld within the previous or next 28 days in the event of a performed or planned intraocular surgery.
• Eylea should not be used in pregnancy unless the potential benefit outweighs the potential risk to the foetus (see section 4.6).
• Women of childbearing potential have to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept (see section 4.6).
• There is limited experience with treatment of patients w |
