Eylea® HD
GoodRxAflibercept 8 mg · intravitreal injection
Injections & Implants
IndicationEYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO).
Contraindications
- Ocular or periocular infections
- Active intraocular inflammation
- Known hypersensitivity to aflibercept or any of the excipients in EYLEA HD
Available Forms8 mg (0.07 mL of a 114.3 mg/mL solution) single-dose glass vial, Vial Kit with Injection Components, Vial Only
Mechanism of ActionVascular 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 leukocytes. 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.
Dosage8 mg (0.07 mL of 114.3 mg/mL solution) by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg once every 8 to 16 weeks, +/- 1 week, for nAMD and DME, or once every 8 to 12 weeks, +/- 1 week, for DR. For RVO, 8 mg every 4 weeks (approximately every 28 days +/- 7 days) for the first three to five doses, followed by 8 mg once every 8 weeks, +/- 1 week. Some patients did not maintain a response with these intervals after successful response to the initial monthly doses, and these patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). For nAMD and DME, 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.
Warnings & Precautions
- Endophthalmitis, Retinal Detachments, and Retinal Vasculitis: Intravitreal injections including those with aflibercept have been associated with endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or without occlusion. Proper aseptic injection technique must always be used when administering EYLEA HD. Patients should be instructed to report any symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
- Increase in Intraocular Pressure: Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA HD. 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.
- 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). Reported rates with EYLEA HD versus EYLEA 2 mg were 1.8% vs 3.3% in PULSAR (wet AMD) and 6.7% vs 7.2% in PHOTON (DME) through week 96, and 0.5% vs 1.7% in QUASAR (RVO) through week 36.
Common Side Effects
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.
Pregnancy & LactationPregnancy: 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. Based on the anti-VEGF mechanism of action for aflibercept, 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.
Females and Males of Reproductive Potential: 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.
Lactation: 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.
Pediatric UseThe safety and effectiveness of EYLEA HD in pediatric patients have not been established.