HIGHLIGHTS OF PRESCRIBING INFORMATION
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
Dosage and Administration, Neovascular (Wet) Age-Related Macular Degeneration (AMD)
：5/2016
Dosage and Administration, Diabetic Macular Edema (DME)：5/2016
Dosage and Administration, Diabetic Retinopathy (DR) in Patients with DME：5/2016
Contraindications, Hypersensitivity：10/2016
INDICATIONS AND USAGE
EYLEA is indicated for the treatment of patients with:
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME)：
Diabetic Retinopathy (DR) in Patients with DME。
DOSAGE AND ADMINISTRATION
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
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).
Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months).
Macular Edema Following Retinal Vein Occlusion (RVO)
The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection once every 4 weeks (monthly).
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in Patients with Diabetic Macular Edema
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).
Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months).
DOSAGE FORMS AND STRENGTHS
40 mg/mL solution for intravitreal injection in a single-use vial：
CONTRAINDICATIONS
Ocular or periocular infection。
Active intraocular inflammation。
Hypersensitivity。
WARNINGS AND PRECAUTIONS
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.
Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
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.
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: 10/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Neovascular (Wet) Age-Related Macular Degeneration ( |
