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warnings and cautions
5 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.
6 ADVERSE REACTIONS 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.