Eylea Aflibercept Intravitreal Injection Solution

1. Indications and Usage
Neovascular (Wet) Age-Related Macular Degeneration (nAMD):
Indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) .
Diabetic Macular Edema (DME):
Indicated for the treatment of patients with diabetic macular edema (DME) .
Macular Edema following Retinal Vein Occlusion (RVO):
Indicated for the treatment of macular edema following both central (CRVO) and branch (BRVO) retinal vein occlusion .
2. Dosage and Administration
Route of Administration:
For Intravitreal Injection ONLY. Must be administered by an ophthalmologist experienced in vitreoretinal injections .
Recommended Dosage:
Dose: 2 mg (50 μL) administered via intravitreal injection .
nAMD Dosing Schedule: Administer once every 4 weeks for the first 3 months, followed by a dose of 2 mg (50 μL) every 8 weeks .
DME Dosing Schedule: Administer once every 4 weeks until maximum improvement in best-corrected visual acuity (BCVA) is achieved, followed by dosing at intervals of up to 8 weeks .
Injection Procedure:
Strict adherence to aseptic injection technique (including use of sterile gloves, mask, drape, lid speculum, and sterile eye drops) is required .
3. Mechanism of Action
Soluble Decoy Receptor:
Aflibercept is a recombinant fusion protein that acts as a soluble decoy receptor .
VEGF and PIGF Inhibition:
It binds to VEGF-A, VEGF-B, and Placental Growth Factor (PlGF), preventing them from interacting with their endogenous receptors (VEGFR-1 and VEGFR-2) on the surface of endothelial cells. This inhibits VEGF-mediated pathological neovascularization and vascular permeability .
4. Safety and Warnings
Intraocular Inflammation and Infection:
Intravitreal injections may be associated with endophthalmitis, uveitis, or intraocular inflammation. Monitor patients after injection .
Retinal Detachment and Vitreous Hemorrhage:
Monitor for signs of retinal detachment and vitreous hemorrhage .
Elevated Intraocular Pressure (IOP):
IOP increases can occur within 60 minutes of injection. Monitor IOP and perform iridectomy if necessary .
Arterial Thromboembolic Events (ATEs):
The risk of stroke or myocardial infarction should be considered. Use with caution in patients with a history of ATEs .
5. Adverse Reactions
Most Common:
Conjunctival hemorrhage (25%), visual acuity reduced (11%), eye pain (10%), cataract (8%), increased IOP (8%), vitreous detachment (7%), and photopsia (7%) .
6. Drug Interactions
Anti-thrombotic Agents:
There is no evidence of drug-drug interactions. However, concomitant use of anti-thrombotic agents may increase the risk of conjunctival hemorrhage .
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Aflibercept. Available in single-use prefilled syringes or vials (2 mg/0.05 mL or 4 mg/0.1 mL depending on formulation) .
Storage:
Store in a refrigerator at 2-8°C. Do not freeze or shake. Protect from light .