al injection, treatment is given monthly. The interval between two doses should not be shorter than one month.
If there is no improvement in visual and anatomic outcomes over the course of the first three injections, continued treatment is not recommended.
Monthly treatment continues until visual and anatomic outcomes are stable for three monthly assessments. Thereafter the need for continued treatment should be reconsidered.
If necessary, treatment may be continued with gradually increasing treatment intervals to maintain a stable visual and anatomic outcome. If treatment has been discontinued, visual and anatomic outcomes should be monitored and treatment should be resumed if these deteriorate.
Usually, monitoring should be done at the injection visits. During treatment interval extension through to completion of therapy, the monitoring schedule should be determined by the treating physician based on the individual patient's response and may be more frequent than the schedule of injections.
Special populations
Hepatic and/or renal impairment
No specific studies in patients with hepatic and/or renal impairment were conducted with Eylea.
Available data do not suggest a need for a dose adjustment with Eylea in these patients (see section 5.2).
Elderly population
No special considerations are needed.
Paediatric population
Safety and efficacy have not been established in children and adolescents. There is no relevant use of Eylea in the paediatric population in the indications wet AMD and CRVO.
Method of administration
Intravitreal injections must be carried out according to medical standards and applicable guidelines by a qualified physician experienced in administering intravitreal injections. In general, adequate anaesthesia and asepsis, including topical broad spectrum microbicide (e.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.
The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 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. If required, sterile equipment for paracentesis should be available.
Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g. eye pain, redness of the eye, photophobia, blurring of vision) without delay.
Each vial should only be used for the treatment of a single eye.
The vial contains more than the recommended dose of 2 mg aflibercept. The extractable volume of the vial (100 microlitres) is not to be used in total. The excess volume should be expelled before injecting.
Injecting the entire volume could result in overdose. To expel the air bubble along with excess medicinal product, slowly depress the plunger to align the cylindrical base of the dome plunger with the black dosing line on the syringe (equivalent to 50 microlitres i.e. 2 mg aflibercept).
After injection any unused product must be discarded.
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