ith ischemic, chronic CRVO. In patients presenting with clinical signs of irreversible ischemic visual function loss, the treatment is not recommended.
• There is limited clinical data with Eylea in patients with diabetic retinopathy.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Adjunctive use of verteporfin photodynamic therapy (PDT) and Eylea has not been studied, therefore, a safety profile is not established.
4.6 Fertility, pregnancy and lactation
Women of childbearing potential
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 4.4).
Pregnancy
There are no data on the use of aflibercept in pregnant women.
Studies in animals have shown embryo-foetal toxicity (see section 5.3).
Although the systemic exposure after ocular administration is very low, Eylea should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Breastfeeding
It is unknown whether aflibercept is excreted in human milk. A risk to the breast-fed child cannot be excluded.
Eylea is not recommended during breastfeeding. A decision must be made whether to discontinue breastfeeding or to abstain from Eylea therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
Results from animal studies with high systemic exposure indicate that aflibercept can impair male and female fertility (see section 5.3). Such effects are not expected after ocular administration with very low systemic exposure.
4.7 Effects on ability to drive and use machines
Injection with Eylea has minor influence on the ability to drive and use machines due to possible temporary visual disturbances associated either with the injection or the eye examination. Patients should not drive or use machines until their visual function has recovered sufficiently.
4.8 Undesirable effects
Summary of the safety profile
wet AMD
A total of 1,824 patients constituted the safety population in the two phase 3 studies with up to 96 weeks of exposure to Eylea, of which 1,223 patients were treated with the 2 mg dose.
Serious adverse reactions related to the injection procedure have occurred in less than 1 in 1,000 intravitreal injections with Eylea and included endophthalmitis, traumatic cataract and transient increased intraocular pressure (see section 4.4).
The most common adverse reactions (in at least 5% of patients treated with Eylea) were conjunctival haemorrhage (26.7%), eye pain (10.3%), vitreous detachment (8.4%), cataract (7.9%), vitreous floaters (7.6%) and increased intraocular pressure (7.2%).
Macular Oedema secondary to CRVO
A total of 317 patients treated with at least one dose of Eylea constituted the safety population in the two phase III studies with up to 100 weeks exposure.
Serious adverse reactions related to the injection procedure occurred in 3 out of 2,728 intravitreal injections with Eylea and included endophthalmitis (see section 4.4), cataract and vitreous detachment.
The most common adverse reactions (in at least 5% of patients treated with Eylea) were conjunctival haemorrhage (15.8%), increased intraocular pressure (12.9%), eye pain (12.6%), vitreous detachment (6.9%), vitreous floaters |
