These highlights do not include all the information needed to use EYLEA safely and effectively. See full prescribing information for EYLEA.
EYLEA ® (aflibercept) Injection
For Intravitreal Injection
Initial U.S. Approval: 2011
RECENT MAJOR CHANGES
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Indications and Usage, Macular Edema Following Retinal Vein Occlusion (RVO) (1.2)
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10/2014 |
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Indications and Usage, Diabetic Macular Edema (DME) (1.3)
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7/2014 |
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Indications and Usage, Diabetic Retinopathy (DR) in Patients with DME (1.4)
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3/2015 |
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Dosage and Administration, Macular Edema Following Retinal Vein Occlusion (RVO) (2.3)
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10/2014 |
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Dosage and Administration, Diabetic Macular Edema (DME) (2.4)
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7/2014 |
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Dosage and Administration, Diabetic Retinopathy (DR) in Patients with DME (2.5)
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3/2015 |
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Warnings and Precautions, Thromboembolic Events (5.3)
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10/2014 |
INDICATIONS AND USAGE
EYLEA is indicated for the treatment of patients with:
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Neovascular (Wet) Age-Related Macular Degeneration (AMD) (1.1)
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Macular Edema Following Retinal Vein Occlusion (RVO) (1.2)
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Diabetic Macular Edema (DME) (1.3)
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Diabetic Retinopathy (DR) in Patients with DME (1.4)
DOSAGE AND ADMINISTRATION
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
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The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first 3 months, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). (2.2)
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Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks. (2.2)
Macular Edema Following Retinal Vein Occlusion (RVO)
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The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection once every 4 weeks (monthly). (2.3)
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in Patients with Diabetic Macular Edema
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The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). (2.4, 2.5)
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Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks. (2.4, 2.5)
DOSAGE FORMS AND STRENGTHS
40 mg/mL solution for intravitreal injection in a single-use vial (3)
CONTRAINDICATIONS
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Ocular or periocular infection (4.1)
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Active intraocular inflammation (4.2)
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Hypersensitivity (4.3)
WARNINGS AND PRECAUTIONS
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Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. (5.1)
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Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. (5.2)
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There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. (5.3)
ADVERSE REACTIONS
The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-855-395-3248 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2015
