Aflibercept 8 mg · intravitreal injection
Injections & Implants
EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Macular Edema Following Retinal Vein Occlusion (RVO)
Contraindications
Ocular or periocular infection Active intraocular inflammation Hypersensitivity.
8 mg, 0.07 mL, 114.3 mg/mL vial
Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells. PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes. Activation of these receptors by VEGF-A can result in neovascularization and vascular permeability.
Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week.
Warnings & Precautions
- Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion: Intravitreal injections including those with aflibercept have been associated with endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or without occlusion . Proper aseptic injection technique must always be used when administering EYLEA HD.
- Increase in Intraocular Pressure: Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA HD . Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular endothelial growth factor (VEGF) inhibitors.
- Thromboembolic Events: There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA HD. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
Common Side Effects
The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment, and vitreous floaters.
Pregnancy: Adequate and well-controlled studies with EYLEA HD have not been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations.
Lactation: There is no information regarding the presence of aflibercept in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion.
The safety and effectiveness of EYLEA HD in pediatric patients have not been established.