Eylea Aflibercept Intravitreous Solution for Injection

1. Indications and Usage
Neovascular (Wet) Age-Related Macular Degeneration (nAMD):
Treatment of patients with nAMD.
Diabetic Macular Edema (DME):
Treatment of patients with DME.
Retinal Vein Occlusion (RVO):
Treatment of macular edema following either central (CRVO) or branch (BRVO) retinal vein occlusion.
Myopic Choroidal Neovascularization (mCNV):
Treatment of patients with mCNV.
2. Dosage and Administration
Route of Administration:
For Intravitreal Injection ONLY. Must be administered by an ophthalmologist.
Recommended Dosage (Standard):
Dose: 2 mg (0.05 mL) per injection.
Schedule:
Initial Phase: Once every 4 weeks (monthly) for the first 3 months.
Maintenance Phase: Once every 8 weeks (every 2 months) thereafter.
Dose Adjustment: The physician may adjust the dosing interval based on disease activity.
Critical Administration Instructions:
Sterile Technique: Administer under sterile conditions with appropriate anesthesia and topical broad-spectrum bacteriostatic agent.
Injection Site: Typically injected into the vitreous cavity (e.g., 3.5 mm posterior to the limbus).
3. Mechanism of Action
Soluble Decoy Receptor:
Aflibercept is a recombinant fusion protein containing parts of human VEGF receptors (VEGFR-1 and VEGFR-2) and the Fc portion of human IgG1.
VEGF Trap:
It binds with high affinity to all isoforms of VEGF-A, VEGF-B, and Placental Growth Factor (PlGF).
Therapeutic Result: By acting as a “trap,” it prevents these growth factors from binding to their natural receptors on the surface of endothelial cells. This inhibits pathological angiogenesis (new blood vessel growth) and reduces vascular permeability (leakage/edema).
4. Safety and Warnings
Endophthalmitis and Retinal Detachment:
Intravitreal injections carry a risk of intraocular infection (endophthalmitis) and retinal detachment.
Intraocular Pressure (IOP) Spikes:
IOP may increase transiently immediately following injection.
Thromboembolic Events:
Non-fatal stroke, myocardial infarction, or vascular death may occur, although the risk is generally low.
Contraindications:
Active or suspected ocular or periocular infections.
Severe active intraocular inflammation.
Hypersensitivity to the drug.
5.Adverse Reactions
Most Common:
Conjunctival hemorrhage (25%), visual acuity decreased (11%), eye pain (10%), cataract (8%), intraocular pressure increased (8%), vitreous detachment (7%), vitreous floaters (7%).
6.Drug Interactions
No Clinical Significance:
No specific drug-drug interaction studies have been conducted. However, concomitant use with other anti-VEGF agents or anti-inflammatory drugs is generally avoided due to lack of safety data.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Aflibercept.
Appearance: Clear, colorless to pale yellow solution.
Packaging: Single-dose vial (2 mg/0.05 mL or 8 mg/0.05 mL depending on region/version).
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake.