Eylea Hd (Aflibercept): Uses, Dosage, Side Effects & Warnings

Q: Who makes Eylea Hd?

Eylea Hd is listed by 1 labeler in the FDA NDC directory, including Regeneron Pharmaceuticals, Inc.

Uses

1 INDICATIONS AND USAGE EYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Diabetic Retinopathy (DR) 1.4 Macular Edema Following Retinal Vein Occlusion (RVO)

Dosage and administration

Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week. ( 2.2 ) Some patients did not maintain a response with 8 mg once every 8 to 16 weeks, +/- 1 week, after successful response to the three initial monthly doses. These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). ( 2.2 ) Extended dosing intervals (8 mg once every 20 weeks, +/- 1 week) may be considered after one year of successful response based on visual and anatomic outcomes. ( 2.2 ). Diabetic Macular Edema (DME) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week. ( 2.3 ) Some patients did not maintain a response with 8 mg once every 8 to 16 weeks, +/- 1 week, after successful response to the three initial monthly doses. These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). ( 2.3 ) Extended dosing intervals (8 mg once every 20 weeks, +/- 1 week) may be considered after one year of successful response based on visual and anatomic outcomes. ( 2.3 ) Diabetic Retinopathy (DR) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 12 weeks, +/- 1 week. ( 2.4 ) Some patients did not maintain a response with 8 mg once every 8 to 12 weeks, +/- 1 week, after successful response to the three initial monthly doses. These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). ( 2.4 ) Macular Edema Following Retinal Vein Occlusion (RVO) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three to five doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 weeks, +/- 1 week. ( 2.5 ) Some patients did not maintain a response with extended dosing intervals after successful response to the first three to five initial monthly doses. These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). ( 2.5 ) 2.1 Important Injection Instructions For ophthalmic intravitreal injection. EYLEA HD must only be administered by a qualified physician. A 5-micron sterile filter needle (18-gauge × 1½-inch), a 1-mL Luer lock syringe and a 30-gauge × ½-inch sterile injection needle are needed. EYLEA HD is available packaged as follows: Vial Only Vial Kit with Injection Components (filter needle, syringe, injection needle) [see How Supplied/Storage and Handling (16) ] . 2.2 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week. Some patients did not maintain a response with 8 mg once every 8 to 16 weeks,+/- 1 week, after successful response to the three initial monthly doses [see Clinical Studies (14.1) ] . These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). Extended dosing intervals (8 mg once every 20 weeks, +/- 1 week) may be considered after one year of successful response based on visual and anatomic outcomes [see Clinical Studies (14.1) ]. 2.3 Diabetic Macular Edema (DME) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week. Some patients did not maintain a response with 8 mg once every 8 to 16 weeks, +/- 1 week, after successful response to the three initial monthly doses [see Clinical Studies (14.2) ] . These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). Extended dosing intervals (8 mg once every 20 weeks, +/- 1 week) may be considered after one year of successful response based on visual and anatomic outcomes [see Clinical Studies (14.2) ]. 2.4 Diabetic Retinopathy (DR) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 12 weeks, +/- 1 week. Some patients did not maintain a response with 8 mg once every 8 to 12 weeks, +/- 1 week, after successful response to the three initial monthly doses [see Clinical Studies (14.3) ] . These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). 2.5 Macular Edema Following Retinal Vein Occlusion (RVO) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three to five doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 weeks, +/- 1 week.

Dosage forms and strengths

3 DOSAGE 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 Injection: 8 mg (0.07 mL of 114.3 mg/mL solution) in a single-dose vial ( 3 )

Contraindications

Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections EYLEA HD is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation EYLEA HD is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity EYLEA HD is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in EYLEA HD. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation.

Warnings and precautions

Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. ( 5.2 ) There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ( 5.3 ) 5.1 Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion Intravitreal injections including those with aflibercept have been associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] and, more rarely, retinal vasculitis with or without occlusion [see Adverse Reactions (6.2) ] . Proper aseptic injection technique must always be used when administering EYLEA HD. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately [see Dosage and Administration (2.7) and Patient Counseling Information (17) ]. 5.2 Increase in Intraocular Pressure Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA HD [see Adverse Reactions (6.1) ]. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular endothelial growth factor (VEGF) inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately [see Dosage and Administration (2.7) ]. 5.3 Thromboembolic Events There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA HD. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in the wet AMD study (PULSAR) from baseline through week 96 was 1.8% (12 out of 673) in the combined group of patients treated with EYLEA HD compared with 3.3% (11 out of 336) in patients treated with EYLEA 2 mg. The incidence of reported thromboembolic events in the DME study (PHOTON) from baseline to week 96 was 6.7% (33 out of 491) in the combined group of patients treated with EYLEA HD compared with 7.2% (12 out of 167) in patients treated with EYLEA 2 mg. The incidence of reported thromboembolic events in the RVO study (QUASAR) from baseline to week 36 was 0.5% (3 out of 591) in the combined group of patients treated with EYLEA HD compared with 1.7% (5 out of 301) in patients treated with EYLEA 2 mg.

Side effects

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥3%) reported in 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-855-395-3248 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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 [see Clinical Studies (14.1 , 14.2) ]. Table 1: Adverse Reactions (≥1%) in at least one group in the PULSAR or PHOTON studies Adverse Reactions PULSAR PHOTON EYLEA HDq12 EYLEA HDq16 EYLEA 2q8 EYLEA HDq12 EYLEA HDq16 EYLEA 2q8 n=335 n=338 n=336 n=328 n=163 n=167 Cataract Represents grouping of related terms 10% 10% 10% 10% 13% 7% Vision blurred 9% 9% 8% 5% 4% 6% Intraocular pressure increased 5% 4% 3% 4% 1% 5% Conjunctival hemorrhage 3% 3% 3% 5% 5% 4% Ocular discomfort/eye pain/eye irritation 3% 4% 4% 5% 4% 4% Vitreous floaters 2% 6% 5% 6% 4% 4% Vitreous detachment 2% 4% 2% 5% 3% 4% Corneal epithelium defect 3% 3% 4% 4% 9% 2% Retinal hemorrhage 5% 6% 6% 0 4% 1% Dry eye 3% 3% 5% 2% 4% 2% Intraocular inflammation 2% 1% 2% 2% 1% 1% Retinal pigment epithelial tear/epitheliopathy 2% 2% 2% 1% 0 0 Vitreous hemorrhage <1% 1% 1% 2% 3% 2% Retinal Detachment 1% 1% <1% <1% 1% 0 Foreign body sensation in eyes 1% 2% 2% <1% 1% 0 Ocular hyperemia 1% <1% 1% <1% 0 0 Retinal pigment epithelial detachment 1% 1% 3% 0 0 0 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). [see Clinical Studies (14.4) ] . Table 2: Most Common Adverse Reactions (≥1%) in at least one group in the QUASAR study Adverse Reactions EYLEA HDq8 following 3 initial doses (HDq4) (N=293) EYLEA HDq8 following 5 initial doses (HDq4) (N=298) EYLEA 2q4 (N=301) Intraocular pressure increased Represents grouping of related terms 7% 6% 3% Vision blurred 5% 3% 2% Conjunctival hemorrhage 3% 2% 2% Ocular discomfort/eye pain/eye irritation 3% 3% 1% Vitreous detachment 3% 3% 1% Cataract 2% 4% 3% Corneal epithelium defect 2% 2% 2% Dry eye 2% 2% 2% Vitreous floaters 1% 1% 1% Intraocular inflammation 1% <1% 1% Vitreous hemorrhage 1% 1% 0 Hypersensitivity Represents reported non-ocular adverse events of hypersensitivity, rash, urticaria and pruritus 1% 1% 1% 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. 6.2 Postmarketing 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.

Use in specific populations

8.1 Pregnancy Risk Summary Adequate and well-controlled studies with EYLEA HD have not been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. A fetal No Observed Adverse Effect Level (NOAEL) was not identified. At the lowest dose shown to produce adverse embryofetal effects, systemic exposure (based on AUC for free aflibercept) was approximately 0.9 -fold of the population pharmacokinetic estimated exposure in humans after an intravitreal dose of 8 mg (see Data ) . Animal reproduction studies are not always predictive of human response, and it is not known whether EYLEA HD can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for aflibercept [see Clinical Pharmacology (12.1) ] , treatment with EYLEA HD may pose a risk to human embryofetal development. EYLEA HD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In two embryofetal development studies, aflibercept produced adverse embryofetal effects when administered every three days during organogenesis to pregnant rabbits at intravenous doses ≥3 mg per kg, or every six days during organogenesis at subcutaneous doses ≥0.1 mg per kg. Adverse embryofetal effects included increased incidences of postimplantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, heart and major vessel defects, and skeletal malformations (fused vertebrae, sternebrae, and ribs; supernumerary vertebral arches and ribs; and incomplete ossification). The maternal No Observed Adverse Effect Level (NOAEL) in these studies was 3 mg per kg. Aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal NOAEL was not identified. At the lowest dose shown to produce adverse embryofetal effects in rabbits (0.1 mg per kg), systemic exposure (AUC) of free aflibercept was approximately 0.9-fold of the population pharmacokinetic estimated systemic exposure (AUC) in humans after an intravitreal dose of 8 mg. 8.2 Lactation Risk Summary There is no information regarding the presence of aflibercept in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, EYLEA HD is not recommended during breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EYLEA HD and any potential adverse effects on the breastfed child from EYLEA HD. 8.3 Females and Males of Reproductive Potential Contraception Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment, and for at least 4 months after the last intravitreal injection of EYLEA HD. Infertility There are no data regarding the effects of EYLEA HD on human fertility. Aflibercept adversely affected female and male reproductive systems in cynomolgus monkeys when administered by intravenous injection at a dose 91 times higher (based on AUC of free aflibercept) than the corresponding systemic level estimated based on population pharmacokinetic analysis in humans following an intravitreal dose of 8 mg. A No Observed Adverse Effect Level (NOAEL) was not identified. These findings were reversible within 20 weeks after cessation of treatment [see Nonclinical Toxicology (13.1) ]. 8.4 Pediatric Use The safety and effectiveness of EYLEA HD in pediatric patients have not been established. 8.5 Geriatric Use In the clinical studies, approximately 66% (1156/1755) of the patients in the HD groups were 65 years of age or older and approximately 31% (543/1755) of the patients were 75 years of age or older. No overall differences in safety or effectiveness of EYLEA HD have been observed.

Pregnancy

8.1 Pregnancy Risk Summary Adequate and well-controlled studies with EYLEA HD have not been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. A fetal No Observed Adverse Effect Level (NOAEL) was not identified. At the lowest dose shown to produce adverse embryofetal effects, systemic exposure (based on AUC for free aflibercept) was approximately 0.9 -fold of the population pharmacokinetic estimated exposure in humans after an intravitreal dose of 8 mg (see Data ) . Animal reproduction studies are not always predictive of human response, and it is not known whether EYLEA HD can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for aflibercept [see Clinical Pharmacology (12.1) ] , treatment with EYLEA HD may pose a risk to human embryofetal development. EYLEA HD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In two embryofetal development studies, aflibercept produced adverse embryofetal effects when administered every three days during organogenesis to pregnant rabbits at intravenous doses ≥3 mg per kg, or every six days during organogenesis at subcutaneous doses ≥0.1 mg per kg. Adverse embryofetal effects included increased incidences of postimplantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, heart and major vessel defects, and skeletal malformations (fused vertebrae, sternebrae, and ribs; supernumerary vertebral arches and ribs; and incomplete ossification). The maternal No Observed Adverse Effect Level (NOAEL) in these studies was 3 mg per kg. Aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal NOAEL was not identified. At the lowest dose shown to produce adverse embryofetal effects in rabbits (0.1 mg per kg), systemic exposure (AUC) of free aflibercept was approximately 0.9-fold of the population pharmacokinetic estimated systemic exposure (AUC) in humans after an intravitreal dose of 8 mg.

Pediatric use

8.4 Pediatric Use The safety and effectiveness of EYLEA HD in pediatric patients have not been established.

Geriatric use

8.5 Geriatric Use In the clinical studies, approximately 66% (1156/1755) of the patients in the HD groups were 65 years of age or older and approximately 31% (543/1755) of the patients were 75 years of age or older. No overall differences in safety or effectiveness of EYLEA HD have been observed.

Overdosage

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.

Description

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.

Mechanism of action

12.1 Mechanism of Action Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells. PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes. Activation of these receptors by VEGF-A can result in neovascularization and vascular permeability. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and PlGF, and thereby can inhibit the binding and activation of these cognate VEGF receptors.

How supplied

16.1 How Supplied EYLEA HD (aflibercept) is a clear to slightly opalescent, colorless to pale yellow solution supplied in the following presentations [see Dosage and Administration (2.6) and (2.7) ]. Each vial is for single eye use only. Discard unused portion. NDC NUMBER CARTON TYPE CARTON CONTENTS 61755-050-01 Vial Kit with Injection Components one EYLEA HD 8 mg (0.07 mL of a 114.3 mg/mL solution), single-dose glass vial one 18-gauge × 1½-inch, 5-micron, filter needle for withdrawal of the vial contents one 30-gauge × ½-inch injection needle for intravitreal injection one 1-mL syringe for administration one Prescribing Information 61755-051-01 Vial Only one EYLEA HD 8 mg (0.07 mL of a 114.3 mg/mL solution) single-dose glass vial one Prescribing Information 16.2 Storage and Handling Refrigerate EYLEA HD at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use beyond the date stamped on the carton and container label. Store in the original carton until time of use to protect from light.

Storage

16.2 Storage and Handling Refrigerate EYLEA HD at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use beyond the date stamped on the carton and container label. Store in the original carton until time of use to protect from light.

Patient 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 [see Warnings and Precautions (5.1) ] . Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA HD and the associated eye examinations [see Adverse Reactions (6.1) ] . Advise patients not to drive or use machinery until visual function has recovered sufficiently.

Active ingredients

Aflibercept in 2 products

Eylea Hd NDC products (2)

NDC	Strength & form	Labeler	Type
61755-050	Aflibercept 8 mg/.07mL Injection, Solution	Regeneron Pharmaceuticals, Inc	BLA
61755-051	Aflibercept 8 mg/.07mL Injection, Solution	Regeneron Pharmaceuticals, Inc	BLA

Frequently asked questions

What is Eylea Hd used for?

1 INDICATIONS AND USAGE EYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 1.1 Neovascular (Wet)…

What are the side effects of Eylea Hd?

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ]… See the full label for the complete list.

Who makes Eylea Hd?

Eylea Hd is listed by 1 labeler in the FDA NDC directory, including Regeneron Pharmaceuticals, Inc.