Eylea Hd
(Aflibercept)Dosage & Administration
By using PrescriberAI, you agree to the AI Terms of Use.
Eylea HD Prescribing Information
Indications and Usage (1.4 Macular Edema Following Retinal Vein Occlusion (RVO) | 11/2025 |
Dosage and Administration (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 extended dosing intervals 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).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 extended dosing intervals 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).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 extended dosing intervals 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).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. Some patients did not maintain a response with extended dosing intervals after successful response to the first three to five initial monthly doses [see Clinical Studies (14.4)] . These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). | 11/2025 |
Warnings and Precautions (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 48 was 0.4% (3 out of 673) in the combined group of patients treated with EYLEA HD compared with 1.5% (5 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 48 was 3.1% (15 out of 491) in the combined group of patients treated with EYLEA HD compared with 3.6% (6 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. | 11/2025 |
EYLEA HD is indicated for the treatment of:
- 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 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 extended dosing intervals 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). - Some patients did not maintain a response with extended dosing intervals 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 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 extended dosing intervals 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).
- 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. (
- 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 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 extended dosing intervals 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). - Some patients did not maintain a response with extended dosing intervals 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 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 extended dosing intervals 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).
- 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. (
- 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 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 extended dosing intervals 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). - Some patients did not maintain a response with extended dosing intervals 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 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 extended dosing intervals 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).
- 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. (
- 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 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.Some patients did not maintain a response with extended dosing intervals after successful response to the first three to five initial monthly doses[see Clinical Studies (14.4)]. These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). - 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 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.Some patients did not maintain a response with extended dosing intervals after successful response to the first three to five initial monthly doses[see Clinical Studies (14.4)]. These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days).
- 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. (
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
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
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.
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
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.
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.
- Ocular or periocular infection ()
4.1 Ocular or Periocular InfectionsEYLEA HD is contraindicated in patients with ocular or periocular infections.
- Active intraocular inflammation ()
4.2 Active Intraocular InflammationEYLEA HD is contraindicated in patients with active intraocular inflammation.
- Hypersensitivity ()
4.3 HypersensitivityEYLEA 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.