Table of Contents
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
--------------------------------------------------------
1. Name of the medicinal product
 Eylea 40 mg/ml solution for injection in a vial.
2. Qualitative and quantitative composition
1 ml solution for injection contains 40 mg aflibercept*.
Each vial contains 100 microlitres, equivalent to 4 mg aflibercept. This provides a usable amount to deliver a single dose of 50 microlitres containing 2 mg aflibercept.
*Fusion protein consisting of portions of human VEGF (Vascular Endothelial Growth Factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
 Solution for injection (injection)
The solution is a clear, colourless to pale yellow and iso-osmotic solution.
4. Clinical particulars
4.1 Therapeutic indications
 Eylea is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AMD) (see section 5.1).
• visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) (see section 5.1).
4.2 Posology and method of administration
 Eylea is for intravitreal injection only.
Eylea must only be administered by a qualified physician experienced in administering intravitreal injections.
Posology
wet AMD
The recommended dose for Eylea is 2 mg aflibercept, equivalent to 50 microlitres.
Eylea treatment is initiated with one injection per month for three consecutive doses, followed by one injection every two months. There is no requirement for monitoring between injections.
After the first 12 months of treatment with Eylea, the treatment interval may be extended based on visual and anatomic outcomes. In this case the schedule for monitoring should be determined by the treating physician and may be more frequent than the schedule of injections.
Macular Oedema secondary to CRVO
The recommended dose for Eylea is 2 mg aflibercept equivalent to 50 microlitres.
After the initi