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  • Eylea
    / Bayer


    Active Ingredient
    Aflibercept 40 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 40 mg/ml

    partial basket chart 51050 5579

    Related information


    Dosage

    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, and based on visual and/or anatomic outcomes, the treatment interval may be extended, such as with a treat-and-extend dosing regimen, where the treatment intervals are gradually increased to maintain stable visual and/or anatomic outcomes; however there are insufficient data to conclude on the length of these intervals. If visual and/or
    anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
    The schedule for monitoring should therefore be determined by the treating physician and may be more frequent than the schedule of injections.
    Macular oedema secondary to RVO (branch RVO or central RVO): The recommended dose for Eylea is 2 mg aflibercept equivalent to 50 microlitres.
    After the initial injection, treatment is given monthly. The interval between two doses should not be shorter than one month.
    If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Eylea should be discontinued.
    Monthly treatment continues until maximum visual acuity is achieved and/or there are no signs of disease activity. Three or more consecutive, monthly injections may be needed.
    Treatment may then be continued with a treat-and-extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes, however there are insufficient data to conclude on the length of these intervals. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
    The monitoring and treatment schedule should be determined by the treating physician based on the individual patient’s response.
    Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
    Diabetic macular oedema: The recommended dose for Eylea is 2 mg aflibercept equivalent to 50 microlitres.
    Eylea treatment is initiated with one injection per month for five 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, and based on visual and/or anatomic outcomes, the treatment interval may be extended, such as with a treat-and-extend dosing regimen, where the treatment intervals are gradually increased to maintain stable visual and/or anatomic outcomes; however there are insufficient data to conclude on the length of these intervals. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
    The schedule for monitoring should therefore be determined by the treating physician and may be more frequent than the schedule of injections.
    If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Eylea should be discontinued.
    Myopic choroidal neovascularisation: The recommended dose for Eylea is a single intravitreal injection of 2 mg aflibercept equivalent to 50 microlitres.
    Additional doses may be administered if visual and/or anatomic outcomes indicate that the disease persists. Recurrences should be treated as a new manifestation of the disease.
    The schedule for monitoring should be determined by the treating physician.
    The interval between two doses should not be shorter than one month.
    Hepatic and/or renal impairment: No specific studies in patients with hepatic and/or renal impairment have been conducted with Eylea.
    Available data do not suggest a need for a dose adjustment with Eylea in these patients.
    Elderly population: No special considerations are needed. There is limited experience in patients older than 75 years with DME.
    Paediatric population: The safety and efficacy of Eylea have not been established in children and adolescents. There is no relevant use of Eylea in the paediatric population for the indications of wet AMD, CRVO, BRVO, DME and myopic CNV.
    For Method of administration please see prescribing information.


    Indications

    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).


    Contra-Indications

    Hypersensitivity to the active substance aflibercept or to any of the excipients. Active or suspected ocular or periocular infection. Active severe intraocular inflammation.


    Special Precautions

    Intravitreal injection-related reactions: Intravitreal injections, including those with Eylea, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract. Proper aseptic injection techniques must always be used when administering Eylea. In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs. Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
    Increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including those with Eylea. 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.
    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. There are limited data on safety in the treatment of patients with CRVO, BRVO, DME or myopic CNV with a history of stroke or transient ischaemic attacks or myocardial infarction within the last 6 months. Caution should be exercised when treating such patients.
    See prescribing information for full details.


    Side Effects

    Serious ocular adverse reactions in the study eye related to the injection procedure have occurred in less than 1 in 1,900 intravitreal injections with Eylea and included blindness, endophthalmitis, retinal detachment, cataract traumatic, cataract, vitreous haemorrhage, vitreous detachment, and intraocular pressure increased.
    The most frequently observed adverse reactions (in at least 5% of patients treated with Eylea) were conjunctival haemorrhage (25%), visual acuity reduced (11%), eye pain (10%), cataract (8%), intraocular pressure increased (8 %), vitreous detachment (7 %), and vitreous floaters (7%).
    See prescribing information for full details.


    Drug interactions

    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.


    Pregnancy and Lactation

    Pregnancy: Women of childbearing potential have to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept. There are no data on the use of aflibercept in pregnant women. Although the systemic exposure after ocular administration is very low, this product should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
    Lactation: It is unknown whether aflibercept is excreted in human milk. A risk to the breast-fed child cannot be excluded.
    See prescribing information for full details.


    Overdose

    In clinical trials doses of up to 4 mg in monthly intervals have been used and isolated cases of overdoses with 8 mg occurred. Overdosing with increased injection volume may increase intraocular pressure. Therefore, in case of overdose intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.


    Important notes

    Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
    Storage: Store in a refrigerator (2°C to 8°C), do not freeze. Keep the vial, in the outer carton in order to protect from light. Prior to usage, the unopened vial may be kept at room temperature (below 25°C) for up to 24 hours. After opening the vial, proceed under aseptic conditions. The vial is for single use only. Since the vial contains more volume (100 microlitres) than the recommended dose (50 microlitres), a part of the volume contained in the vial has to be discarded prior to the administration.
    Effects on ability to drive and use machines: Injection with this product has a 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.
    See prescribing information for full details.


    Manufacturer
    Bayer Pharma AG
    Licence holder
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