Age-related macular degeneration: Intravitreal: 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).
Diabetic macular edema: Intravitreal: 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).
Diabetic retinopathy: Intravitreal: 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).
Macular edema following retinal vein occlusion: Intravitreal: 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.
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)
Solution Prefilled Syringe, Intravitreal [preservative free]:
Eylea: 2 mg/0.05 mL (0.05 mL)
No
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.
Age-related macular degeneration: Treatment of neovascular (wet) age-related macular degeneration.
Diabetic macular edema: Treatment of diabetic macular edema.
Diabetic retinopathy: Treatment of diabetic retinopathy.
Macular edema: Treatment of macular edema following retinal vein occlusion.
Aflibercept may be confused with Ziv-aflibercept
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Ophthalmic: Conjunctival hemorrhage (12% to 31%), cataract (≤19%), eye pain (9% to 13%)
1% to 10%:
Cardiovascular: Arterial thrombosis (2% to 6%)
Central nervous system: Foreign body sensation of eye (3% to 4%)
Immunologic: Antibody development (1% to 3%)
Local: Pain at injection site (1% to 3%), bleeding at injection site (≤2%)
Ophthalmic: Increased intraocular pressure (2% to 9%), vitreous detachment (2% to 8%), vitreous opacity (1% to 8%), epithelial keratopathy (2% to 7%), ocular hyperemia (4% to 5%), retinal pigment epithelium detachment (3% to 5%), increased lacrimation (3% to 4%), blurred vision (1% to 4%), intraocular inflammation (1% to 3%), retinal pigment epithelium tear (2%), eyelid edema (≤2%), corneal edema (≤1%), retinal detachment (<1%)
<1%, postmarketing, and/or case reports: Endophthalmitis, hypersensitivity reaction
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: Intravitreous injections are associated with endophthalmitis, retinal detachments, retinal tear, retinal pigment epithelium tear, and cataract, including traumatic cataract. Use proper aseptic injection techniques. Instruct patients to report any signs of infection (eg, eye pain or redness, photophobia, blurred vision) 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.
None known.
There are no known significant interactions.
Evaluate pregnancy status prior to use in females of reproductive potential. Women of reproductive potential should use effective contraception prior to initial dose, during treatment, and for at least 3 months after the last intravitreal injection.
Aflibercept (ophthalmic) is a vascular endothelial growth factor (VEGF) inhibitor; VEGF is required to achieve and maintain normal pregnancies. Reports of intravitreal VEGF inhibitor use in pregnancy are limited and information specific to use of aflibercept (ophthalmic) has not been located (Peracha 2016). 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). Until additional information is 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).
It is not known if aflibercept (ophthalmic) is present in breast milk.
Due to the potential for adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.
Intraocular pressure immediately following injection; signs of infection/inflammation (for first week following injection); optic nerve head perfusion; signs/symptoms of endophthalmitis or retinal detachment; visual acuity; signs/symptoms of hypersensitivity reaction.
Evaluate pregnancy status prior to use in females of reproductive potential.
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 L (IV)
Half-life elimination: Plasma: ~5 to 6 days (IV)
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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