Version May 2024
Age-related macular degeneration: Intravitreal:
Eylea: 2 mg (0.05 mL) once every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg (0.05 mL) once every 8 weeks (every 2 months). Although may be administered every 4 weeks, additional efficacy has not been demonstrated (compared with every-8-week administration); some patients may require every-4-week (monthly) dosing after the first 12 weeks of therapy (first 3 injections). Some patients may also be treated every 12 weeks (3 months) after one year of effective treatment (not as effective as every-8-week administration).
Eylea HD: 8 mg (0.07 mL) once every 4 weeks (approximately every 21 to 35 days) for the first 3 doses, followed by 8 mg (0.07 mL) once every 8 to 16 weeks (±1 week).
Diabetic macular edema: Intravitreal:
Eylea: 2 mg (0.05 mL) once every 4 weeks (monthly) for the first 5 injections, followed by 2 mg (0.05 mL) once every 8 weeks (every 2 months). Although may be administered every 4 weeks, additional efficacy has not been demonstrated (compared with every-8-week administration); some patients may require every-4-week (monthly) dosing after the first 20 weeks of therapy (first 5 injections).
Eylea HD: 8 mg (0.07 mL) once every 4 weeks (approximately every 21 to 35 days) for the first 3 doses, followed by 8 mg (0.07 mL) once every 8 to 16 weeks (±1 week).
Diabetic retinopathy: Intravitreal:
Eylea: 2 mg (0.05 mL) once every 4 weeks (monthly) for the first 5 injections, followed by 2 mg (0.05 mL) once every 8 weeks (every 2 months). Although may be administered every 4 weeks, additional efficacy has not been demonstrated (compared with every-8-week administration); some patients may require every-4-week (monthly) dosing after the first 20 weeks of therapy (first 5 injections).
Eylea HD: 8 mg (0.07 mL) once every 4 weeks (approximately every 21 to 35 days) for the first 3 doses, followed by 8 mg (0.07 mL) once every 8 to 12 weeks (±1 week).
Macular edema following retinal vein occlusion: Intravitreal: Eylea: 2 mg (0.05 mL) once every 4 weeks (monthly).
No dosage adjustment necessary.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, no adjustment expected due to minimal systemic absorption.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults who were administered Eylea, unless otherwise noted.
>10%: Ophthalmic: Cataract (neonates and infants: 1%; adults: ≤19%, Eylea HD: 3% to 6%), conjunctival hemorrhage (neonates and infants: 5% to 9%; adults: 12% to 31%, Eylea HD: 2% to 4%), eye pain (9% to 13%; Eylea HD: ≤4%)
1% to 10%:
Cardiovascular: Arterial thrombosis (2% to 6%; Eylea HD: ≤3%)
Immunologic: Antibody development (neonates, infants, and adults: ≤3%, Eylea HD: 3%)
Local: Bleeding at injection site (≤2%; Eylea HD: <1%), pain at injection site (1% to 3%)
Ophthalmic: Blurred vision (1% to 4%; Eylea HD: 3% to 6%), corneal edema (neonates, infants, and adults: ≤1%), epithelial keratopathy (neonates and infants: 1%; adults: 2% to 7%, Eylea HD 2% to 6%), eye discomfort (Eylea HD: ≤4%), eye irritation (Eylea HD: ≤4%), eyelid edema (neonates, infants, and adults: ≤3%, Eylea HD: ≤1%), foreign body sensation of eye (3% to 4%; Eylea HD: ≤1%), increased intraocular pressure (neonates, infants, and adults: 2% to 9%; Eylea HD: 1% to 4%), increased lacrimation (3% to 4%; Eylea HD: <1%), intraocular inflammation (1% to 3%; Eylea HD: 1%), ocular epitheliopathy (Eylea HD: ≤2%), ocular hyperemia (2% to 5%; Eylea HD: <1%; including conjunctival irritation and conjunctival hyperemia), retinal detachment (neonates and infants: 5% to 6%; adults: <1%, Eylea HD: ≤1%), retinal hemorrhage (Eylea HD: 3% to 4%), retinal pigment epithelium detachment (3% to 5%; Eylea HD: 1%), retinal pigment epithelium tear (2%; Eylea HD: ≤2%), vitreous detachment (2% to 8%; Eylea HD: 2% to 4%), vitreous hemorrhage (Eylea HD: ≤2%), vitreous opacity (1% to 8%; Eylea HD: 1% to 5%)
<1%:
Hypersensitivity: Hypersensitivity reaction (Eylea, Eylea HD)
Ophthalmic: Endophthalmitis
Known hypersensitivity to aflibercept or any component of the formulation; current ocular or periocular infection; active intraocular inflammation
Concerns related to adverse effects:
• Endophthalmitis/retinal detachment/retinal vasculitis: Intravitreous injections are associated with endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion (rare). Use proper aseptic injection techniques. Instruct patients to report any signs of endophthalmitis, retinal detachment, or retinal vasculitis immediately; manage appropriately.
• Hypersensitivity reactions: Hypersensitivity may present as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation.
• Increased intraocular pressure: Following intravitreal injection, intraocular pressure may increase (acute). Onset is seen within 60 minutes. Sustained increases in intraocular pressure have also been reported (with repeated dosing of intravitreal VEGF inhibitors). Monitor intraocular pressure and optic nerve head perfusion.
• Thromboembolic events: Risk of thromboembolic events (eg, nonfatal stroke/MI, vascular death) may be increased following intravitreal administration of VEGF inhibitors, including aflibercept.
Disease-related concerns:
• Retinopathy of prematurity (ROP): Following intravitreal injection, abnormal angiogenesis and tortuosity may recur. Infants should be closely monitored until retinal vascularization is complete or assurance that reactivation of ROP will not occur.
Systemic absorption of vascular endothelial growth factor (VEGF) inhibitors along with subsequent suppression of VEGF serum concentrations has been reported following intravitreal administration of VEGF inhibitors, including aflibercept, for treatment of retinopathy of prematurity (ROP); aflibercept concentrations were detected in systemic circulation at 4 weeks and VEGF concentrations were suppressed for at least 8 weeks postinjection (Furuncuoglu 2022). A report of ischemic stroke in a preterm neonate 1 week following aflibercept intravitreal injection for the treatment of aggressive posterior ROP has been documented; the infant had a history of hypertension; evaluate the risks and benefits of aflibercept therapy in patients at risk for thromboembolic events (Bazvand 2020). The neurodevelopmental impact of systemic exposure and suppression of VEGF concentrations is unknown; monitoring is recommended.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravitreal [preservative free]:
Eylea: 2 mg/0.05 mL (0.05 mL)
Eylea HD: 8 mg/0.07 mL (0.07 mL)
Solution Prefilled Syringe, Intravitreal [preservative free]:
Eylea: 2 mg/0.05 mL (0.05 mL)
No
Solution (Eylea HD Intravitreal)
8MG/0.07ML (per 0.07 mL): $3,150.00
Solution (Eylea Intravitreal)
2 mg/0.05 mL (per 0.05 mL): $2,220.00
Solution Prefilled Syringe (Eylea Intravitreal)
2 mg/0.05 mL (per 0.05 mL): $2,220.00
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravitreal:
Eylea: 2 mg/0.05 mL (0.05 mL)
Solution Prefilled Syringe, Intravitreal:
Eylea: 2 mg/0.05 mL (0.05 mL)
Intravitreal: For ophthalmic intravitreal injection under controlled aseptic conditions. Each vial or prefilled syringe should only be used for the treatment of a single eye. Press plunger carefully and with constant pressure during administration; do not apply additional pressure once the plunger has reached the bottom of the syringe. A small residual volume may remain in the prefilled syringe after dose is injected; do not administer any residual solution remaining in syringe. If the contralateral eye requires treatment, a new vial or prefilled syringe should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before aflibercept is administered to the other eye. Should be administered using a 30-gauge 1/2-inch sterile needle. Adequate anesthesia and a topical broad-spectrum antimicrobial agent should be administered prior to the procedure.
Eylea: Intravitreal injection:
Retinopathy of prematurity (ROP): Premature neonates: Use vial only; prefilled syringe not recommended for treatment of ROP. For ophthalmic intravitreal injection under controlled aseptic conditions. Each vial should only be used for the treatment of a single eye. Prior to injection, administer adequate anesthesia and a topical broad-spectrum antimicrobial agent. Administer aflibercept using a 30-gauge, 1/2-inch sterile needle. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before aflibercept is administered to the other eye. See manufacturer's labeling for detailed information.
Age-related macular degeneration (Eylea, Eylea HD): Treatment of neovascular (wet) age-related macular degeneration.
Diabetic macular edema (Eylea, Eylea HD): Treatment of diabetic macular edema.
Diabetic retinopathy (Eylea, Eylea HD): Treatment of diabetic retinopathy.
Macular edema (Eylea only): Treatment of macular edema following retinal vein occlusion.
Retinopathy of prematurity (Eylea only): Treatment of retinopathy of prematurity.
Aflibercept may be confused with Ziv-aflibercept
None known.
There are no known significant interactions.
Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception prior to initial dose, during treatment, and for at least 3 months (Eylea) or 4 months (Eylea HD) after the last intravitreal injection.
Outcome data following maternal use of ophthalmic aflibercept (Sakai 2022) and other intravitreal vascular endothelial growth factor (VEGF) inhibitors during pregnancy are limited (Naderan 2021).
Based on studies in nonpregnant adults, VEGF inhibitors can alter systemic concentrations of VEGF and placental growth factor following intravitreal administration (Peracha 2016; Zehtner 2015). Aflibercept is a VEGF inhibitor; VEGF is required to achieve and maintain normal pregnancies. Until additional data are available, intravitreal use during the first trimester should be avoided and use later in pregnancy should be based on patient specific risks versus benefits (Peracha 2016; Polizzi 2015).
Aflibercept is present in breast milk following intravitreal administration (Juncal 2020).
Data related to the presence of aflibercept in breast milk are available from one patient diagnosed with diabetic macular edema. Aflibercept 2 mg was injected intravitreally 1 week postpartum. Breast milk was collected prior to the injection and over the next 4 days. The patient did not breastfeed or pump breast milk outside of the study visits. Aflibercept was detected in breast milk on study day 4 (10.9 ng/mL). Levels of vascular endothelial growth factor-A in breast milk decreased from baseline (10.6 ng/mL) to 4.9 ng/mL on study day 1 (Juncal 2020).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Intraocular pressure immediately following injection; signs of infection/inflammation (for first week following injection); optic nerve head perfusion or tonometry; signs/symptoms of endophthalmitis or retinal detachment; visual acuity; signs/symptoms of hypersensitivity reaction.
Evaluate pregnancy status prior to use in patients who could become pregnant.
Aflibercept is a recombinant fusion protein that acts as a decoy receptor for vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PLGF). Aflibercept binds to VEGF-A and PLGF and inhibits binding and activating of endothelial cell receptors, thereby suppressing neovascularization and slowing vision loss.
Absorption: Low levels are detected in the serum following intravitreal injection; levels undetectable 2 weeks after administration.
Distribution: ~6 to 7 L (IV).
Half-life elimination: Plasma: ~5 to 6 days (IV).
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