eylea hd
Pharmaranks rates Eylea Hd 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Eylea Hd (Aflibercept) is a medication used to treat Diabetic Retinopathy, Macular Edema.
Aflibercept · by Regeneron Pharmaceuticals
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Aflibercept
- Form
- Injectable
- Strength
- Aflibercept 8MG(0.07ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- diabetic retinopathy, macular edema
- Manufacturer
- Regeneron Pharmaceuticals
- FDA application
- BLA761355
What is Eylea Hd?
From the FDA label: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.
How to use
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…
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,…
Warnings
Important safety information
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.
Who should not take Eylea Hd
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.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Eylea Hd treat?
- Eylea Hd (Aflibercept) may be used to treat diabetic retinopathy, macular edema, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Eylea Hd rated?
- pharmaranks gives Eylea Hd a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Eylea Hd?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Eylea Hd. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Eylea Hd?
- Eylea Hd is marketed by Regeneron Pharmaceuticals. You can see Regeneron Pharmaceuticals's full profile, rating, and other products on pharmaranks.
- Is Eylea Hd a brand-name or generic drug?
- Eylea Hd is a brand-name product with the active ingredient Aflibercept.
- Is Eylea Hd available over the counter?
- No. Eylea Hd is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Eylea Hd come in?
- Eylea Hd is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Eylea Hd FDA-registered?
- Eylea Hd is on record with the U.S. FDA under application number BLA761355. You can verify this on its official FDA label.
- Has Eylea Hd been recalled by the FDA?
- Eylea Hd has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Eylea Hd safe?
- There's no single safe-or-not verdict. pharmaranks gives Eylea Hd a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Eylea Hd?
- Eylea Hd's side effects are taken directly from its FDA label. From the label: The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis, Retinal Detachments,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
pavblu
Aflibercept-Ayyh
lucentis
Ranibizumab
susvimo
Ranibizumab
vabysmo
Faricimab-Svoa
cimerli
Ranibizumab-Eqrn
ahzantive
Aflibercept-Mrbb
Compare Eylea Hd head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
eylea hd
70/100