Aflibercept Application Scope

Eylea (aflibercept) is indicated for the treatment of: neovascular (wet) age‑related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and retinopathy of prematurity (ROP) in preterm infants.

Aflibercept Characteristics

Ingredients:Active: aflibercept (recombinant fusion protein VEGFR‑1/VEGFR‑2 extracellular domains fused to human IgG1 Fc) at 40 mg/mL (2 mg/0.05 mL dose).
Excipients (vial/prefilled syringe formulations, 40 mg/mL): sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, sucrose, water for injections.
Properties:Sterile, clear to pale yellow aqueous solution; preservative‑free; administered via intravitreal injection.
Packaging Specification:Single‑dose vial or single‑dose pre‑filled glass syringe: 2 mg (0.05 mL) of aflibercept at 40 mg/mL.
Storage:Store refrigerated at 2 °C to 8 °C; do not freeze; keep in original carton to protect from light. Unopened vial may be kept at ≤ 25 °C for up to 24 hours.
Expiry Date:Shelf life: 2 years from manufacture. Expiry is the last day of the stated month.
Executive Standard: EU marketing authorization number EU/1/12/797/001.
Approval Number:FDA: BLA 125387, first approved November 18, 2011 (US label updated October 2024).
Date of Revision:US prescribing information revised October 2024. EU product monograph revision April 14, 2025.
Manufacturer:Regeneron Pharmaceuticals, Inc. (US); Marketing Authorization Holder: Bayer AG, Leverkusen, Germany (EU).

Guidelines for the Use of Eylea

Dosage and Administration:
- Recommended Dose: 2 mg (0.05 mL of 40 mg/mL solution) intravitreal injection once every 4 weeks (≈28 days) for initial induction (e.g., first 3 months for AMD, first 5 injections for DME/DR), followed by maintenance dosing every 8 weeks. Some patients may require continuing monthly dosing beyond initial period.
- Administration: Administer via intravitreal injection using single‑dose vial or pre‑filled syringe under aseptic conditions by a qualified physician. Discard unused portion.
- Missed Dose: If a dose is missed, administer as soon as possible and resume monthly dosing from the date of the most recently administered dose (aligns with “every 4‑week” guidance).

Adverse Reactions:

Common Adverse Reactions (≥5% and >3% higher than placebo):

Conjunctival hemorrhage, eye pain, cataract, vitreous detachment, floaters, ocular hypertension.(These ocular injection‑related events often meet incidence thresholds.)

Serious Adverse Reactions:

Hypersensitivity reactions, including bronchospasm, diffuse erythema, facial swelling, urticaria, chills, myalgias. Endophthalmitis and retinal detachment have been reported following injection.
Contraindications:Patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA.
Precautions:
- Hypersensitivity Reactions: Monitor for symptoms; discontinue use if reaction occurs.
- Platelet Count Monitoring: Although systemic exposure is minimal, monitor as appropriate in patients with risk factors.
- Pregnancy and Lactation: Advise patients to inform HCP if pregnant, planning pregnancy, or breastfeeding.

Aflibercep Interactions

No known significant drug interactions described with intravitreal aflibercept.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.