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Generic Name
Aflibercept
Brand Names
Eylea, Pavblu, Zaltrap
FDA approval date: November 21, 2011
Classification: Vascular Endothelial Growth Factor Inhibitor
Form: Injection, Solution
What is Eylea (Aflibercept)?
EYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor inhibitor indicated for the treatment of patients with: Neovascular Age-Related Macular Degeneration .
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Brand Information
EYLEA HD (aflibercept)
1INDICATIONS AND USAGE
EYLEA HD is indicated for the treatment of:
2DOSAGE FORMS AND STRENGTHS
EYLEA HD is a clear to slightly opalescent, colorless to pale yellow solution available as:
- Injection: 8 mg (0.07 mL of a 114.3 mg/mL solution) in a single-dose glass vial
3ADVERSE REACTIONS
The following potentially serious adverse reactions are described elsewhere in the labeling:
- Hypersensitivity
- Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion
- Increase in intraocular pressure
- Thromboembolic events
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice.
A total of 1755 patients were treated with EYLEA HD and 804 patients were treated with EYLEA 2 mg in three clinical studies. The most common adverse reactions reported in ≥3% of 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.
Neovascular (Wet) Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)
The data described below reflect exposure to EYLEA HD administered every 12 weeks (HDq12), EYLEA HD administered every 16 weeks (HDq16), or EYLEA 2 mg administered every 8 weeks (2q8) in controlled clinical studies (PULSAR and PHOTON), each for 96 weeks
Adverse drug reactions (ADRs) reported in <1% of participants treated with EYLEA HD were lacrimation increased, eyelid edema, hypersensitivity (includes adverse events of rash, urticaria, pruritus), and injection site hemorrhage.
Macular Edema Following Retinal Vein Occlusion (RVO)
The data described below reflects 36 weeks exposure to EYLEA HD administered every 8 weeks (HDq8) after 3 or 5 initial monthly doses (HDq4), or EYLEA 2 mg administered every 4 weeks (2q4) in a controlled clinical study (QUASAR).
Adverse reactions reported in <1% of the patients treated with EYLEA HD in the RVO study were foreign body sensation in eyes (includes foreign body sensation in eyes and sensation of foreign body), ocular hyperaemia (includes conjunctival hyperemia, conjunctival irritation, ocular hyperemia), retinal hemorrhage, retinal pigment epithelial detachment (includes detachment of retinal pigment epithelium), retinal pigment epithelial tear/epitheliopathy (includes retinal pigment epitheliopathy), and retinal tear.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of aflibercept. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye disorders:
- Retinal vasculitis and occlusive retinal vasculitis related to intravitreal injection with aflibercept (reported at a rate of 0.6 and 0.2 per 1 million injections, respectively, based on postmarketing experience from November 2011 until November 2023).
- Scleritis.
4OVERDOSAGE
Overdosing with increased injection volume may increase intraocular pressure. Therefore, in case of overdosage, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.
5DESCRIPTION
Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.
EYLEA HD (aflibercept) injection is a sterile, clear to slightly opalescent, and colorless to pale yellow solution. EYLEA HD is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose glass vial designed to deliver 0.07 mL (70 microliters) of solution containing 8 mg of aflibercept in a buffer containing arginine hydrochloride (0.737 mg), histidine (0.04 mg), L-histidine hydrochloride monohydrate (0.093 mg), polysorbate 20 (0.021 mg), sucrose (3.5 mg) and water for injection with a pH of 5.8. EYLEA HD does not contain an anti-microbial preservative.
6PATIENT COUNSELING INFORMATION
In the days following EYLEA HD administration, patients are at risk of developing endophthalmitis, retinal detachment, or retinal vasculitis with or without occlusion. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients and/or caregivers to seek immediate care from an ophthalmologist
Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA HD and the associated eye examinations
7PRINCIPAL DISPLAY PANEL - 0.07 mL Vial Carton - 050
NDC 61755-050-01
Rx ONLY
EYLEA
8 mg (0.07 mL of a 114.3 mg/mL solution)
For Intravitreal Injection.
Carton contents:
- one aflibercept 8 mg/0.07 mL single-dose glass vial
- one 18-gauge × 1½-inch, 5-micron, filter needle for withdrawal
- one 30-gauge × ½-inch injection needle for intravitreal injection
- one 1-mL syringe for administration
- one Prescribing Information
REGENERON
8PRINCIPAL DISPLAY PANEL - 0.07 mL Vial Carton - 051
NDC 61755-051-01
Rx ONLY
EYLEA
8 mg (0.07 mL of a 114.3 mg/mL solution)
For Intravitreal Injection.
Carton contents:
- one aflibercept 8 mg/0.07 mL single-dose glass vial
- one Prescribing Information
REGENERON
