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EYLEA HD aflibercept 8 mg/.07mL Injection, Solution, 1 vial — NDC 61755-0051-01 package photo

EYLEA HD aflibercept 8 mg/.07mL Injection, Solution, 1 vial

by Regeneron Pharmaceuticals, Inc · 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-051-01) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-051-00)
NDC 61755-0051-01
🏷️ FDA NDC (as labeled) 61755-051-01 billing pads the product segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Also comes in: 1 vial 61755-0051-51
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 61755-051-01
Product NDC 61755-051
11-digit billing NDC 61755005101
RxCUI 2645305, 2645308
UNII 15C2VL427D
Application # BLA761355
SPL Set ID 86d8848b-111b-4da9-8957-7cccef1b8f66
Established class (EPC) Vascular Endothelial Growth Factor Inhibitor
Mechanism of action Vascular Endothelial Growth Factor Inhibitors
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-18
Route INTRAVITREAL
Dosage form INJECTION, SOLUTION
Substance AFLIBERCEPT
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 61755-051-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 61755-0051-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Vascular Endothelial Growth Factor Inhibitor class.

Pharmacologic class Vascular Endothelial Growth Factor Inhibitor
Drug family (ATC) Other antineoplastic agents, Antineovascularisation agents
How it works Vascular Endothelial Growth Factor Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerRegeneron Pharmaceuticals, Inc
FDA applicationBLA761355 (BLA)
Labeler code61755
First marketedAug 2023
Product typeHuman Prescription Drug
Portfolio8 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Right now, injecting aflibercept directly into the eye is the only way the medication works for these conditions. It needs to reach the retina in high enough concentrations to bloc...
  • Why do I need injections in my eye — is there any other way to take this?
  • It depends on your specific condition. For wet AMD and diabetic conditions, you'll typically start with monthly injections for a few months, and then your doctor will likely space...
  • How often will I need to come in for injections?
📖 Read our full Aflibercept Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F7LTH1E20Y
    Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 vial
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eylea Hd 8 mg/.07mL 61755-0050-01 Regeneron 1 vial — — FDA listed —
Eylea Hd 8 mg/.07mLthis 61755-0051-01 Regeneron 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2023
First FDA approval
Aug 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
2026
Biosimilars listed
6 FDA-licensed
🧬FDA-licensed biosimilars listed

5 biosimilars and 1 interchangeable are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)

🛡️ Latest patent/protection date listed: Biosimilars are already FDA-licensed for this product — the last listed patent runs to May 2042.
📅 FDA approved Aug 18, 2023

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Eyleaaflibercept Eylea HDaflibercept
Interchangeable 1
Opuvizaflibercept-yszy
Biosimilars 5
Ahzantiveaflibercept-mrbb Enzeevuaflibercept-abzv Eydenzeltaflibercept-boav Pavbluaflibercept-ayyh Yesafiliaflibercept-jbvf
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
US 11,084,865 — biologic patent
US 11,104,715 — biologic patent
US D934,069 — biologic patent
US 11,160,918 — biologic patent
US 11,174,283 — biologic patent
US 11,186,625 — biologic patent
US 11,253,572 — biologic patent
US 11,299,532 — biologic patent
US 11,306,135 — biologic patent
US 11,332,771 — biologic patent
US D961,376 — biologic patent
US D961,377 — biologic patent
US 11,433,186 — biologic patent
US 11,439,758 — biologic patent
US 11,459,373 — biologic patent
US 11,459,374 — biologic patent
US 11,472,861 — biologic patent
US 11,478,588 — biologic patent
US 11,485,770 — biologic patent
US 11,505,593 — biologic patent
US 11,649,273 — biologic patent
US 11,821,001 — biologic patent
US 12,077,570 — biologic patent
US 12,268,730 — biologic patent
US 12,282,004 — biologic patent
US 12,280,093 — biologic patent
US 11,559,564 — biologic patent
US 11,732,024 — biologic patent
US 11,535,663 — biologic patent
US 11,542,317 — biologic patent
US 11,707,506 — biologic patent
US 11,753,459 — biologic patent
US 11,769,597 — biologic patent
US 11,788,102 — biologic patent
US 11,793,926 — biologic patent
US 7,771,997 — biologic patent
US 9,315,281 — biologic patent
US 9,932,605 — biologic patent
US 10,182,969 — biologic patent
US 11,103,552 — biologic patent
US 11,268,109 — biologic patent
US 11,312,936 — biologic patent
US 11,525,833 — biologic patent
US 9,562,238 — biologic patent
US 11,549,154 — biologic patent
US 11,680,930 — biologic patent
US 11,850,407 — biologic patent
US 11,548,932 — biologic patent
US 11,555,176 — biologic patent
US 10,669,594 — biologic patent
US 11,732,025 — biologic patent
US 7,070,959 — biologic patent
US 9,222,106 — biologic patent
US 9,254,338 — biologic patent
US 9,669,069 — biologic patent
US 9,816,110 — biologic patent
US 10,130,681 — biologic patent
US D858,754 — biologic patent
US 10,406,226 — biologic patent
US 10,415,055 — biologic patent
US 10,464,992 — biologic patent
US 11,066,458 — biologic patent
US 10,828,345 — biologic patent
US 10,857,205 — biologic patent
US 10,857,231 — biologic patent
US D906,102 — biologic patent
US 10,888,601 — biologic patent
US 10,905,786 — biologic patent
US 10,918,754 — biologic patent
US 10,927,342 — biologic patent
US 10,973,879 — biologic patent
US 11,053,280 — biologic patent
US 12,054,533 — biologic patent
US 11,918,785 — biologic patent
US 11,970,724 — biologic patent
US 11,975,045 — biologic patent
US 11,986,511 — biologic patent
US D1,035,436 — biologic patent
US D1,042,107 — biologic patent
US 12,116,622 — biologic patent
US D1,047,700 — biologic patent
US 12,163,122 — biologic patent
US 12,168,036 — biologic patent
US 12,202,883 — biologic patent
US 11,577,025 — biologic patent
US 12,221,619 — biologic patent
US 10,961,500 — biologic patent
US 11,286,460 — biologic patent
Exclusivity RefProduct
2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

Listed patents (88)
PatentTypeUse codeExpires
US 11,084,865 ↗ Biologic patent — Jun 14, 2027
US 11,104,715 ↗ Biologic patent — Aug 18, 2040
US D934,069 ↗ Biologic patent — Oct 26, 2036
US 11,160,918 ↗ Biologic patent — Jul 29, 2040
US 11,174,283 ↗ Biologic patent — Aug 18, 2040
US 11,186,625 ↗ Biologic patent — Aug 18, 2040
US 11,253,572 ↗ Biologic patent — Jan 11, 2032
US 11,299,532 ↗ Biologic patent — Aug 18, 2040
US 11,306,135 ↗ Biologic patent — Aug 18, 2040
US 11,332,771 ↗ Biologic patent — Mar 14, 2034
US D961,376 ↗ Biologic patent — Aug 23, 2037
US D961,377 ↗ Biologic patent — Aug 23, 2037
US 11,433,186 ↗ Biologic patent — Dec 12, 2038
US 11,439,758 ↗ Biologic patent — Jun 4, 2040
US 11,459,373 ↗ Biologic patent — Aug 18, 2040
US 11,459,374 ↗ Biologic patent — Aug 18, 2040
US 11,472,861 ↗ Biologic patent — Aug 18, 2040
US 11,478,588 ↗ Biologic patent — Jul 25, 2040
US 11,485,770 ↗ Biologic patent — Aug 18, 2040
US 11,505,593 ↗ Biologic patent — Aug 18, 2040
US 11,649,273 ↗ Biologic patent — Aug 18, 2040
US 11,821,001 ↗ Biologic patent — Jan 27, 2040
US 12,077,570 ↗ Biologic patent — Aug 18, 2040
US 12,268,730 ↗ Biologic patent — Jan 11, 2032
US 12,282,004 ↗ Biologic patent — Dec 9, 2041
US 12,280,093 ↗ Biologic patent — May 17, 2039
US 11,559,564 ↗ Biologic patent — Jan 11, 2032
US 11,732,024 ↗ Biologic patent — Jun 14, 2027
US 11,535,663 ↗ Biologic patent — Aug 18, 2040
US 11,542,317 ↗ Biologic patent — Aug 18, 2040
US 11,707,506 ↗ Biologic patent — Jan 11, 2032
US 11,753,459 ↗ Biologic patent — Aug 18, 2040
US 11,769,597 ↗ Biologic patent — Aug 15, 2038
US 11,788,102 ↗ Biologic patent — Oct 21, 2035
US 11,793,926 ↗ Biologic patent — Jul 29, 2040
US 7,771,997 ↗ Biologic patent — Jul 2, 2028
US 9,315,281 ↗ Biologic patent — Sep 16, 2034
US 9,932,605 ↗ Biologic patent — Jun 4, 2028
US 10,182,969 ↗ Biologic patent — Jul 13, 2037
US 11,103,552 ↗ Biologic patent — May 15, 2039
US 11,268,109 ↗ Biologic patent — Oct 21, 2035
US 11,312,936 ↗ Biologic patent — Aug 3, 2036
US 11,525,833 ↗ Biologic patent — Nov 29, 2040
US 9,562,238 ↗ Biologic patent — Jun 4, 2028
US 11,549,154 ↗ Biologic patent — Dec 25, 2036
US 11,680,930 ↗ Biologic patent — Oct 25, 2037
US 11,850,407 ↗ Biologic patent — Sep 18, 2039
US 11,548,932 ↗ Biologic patent — Aug 18, 2040
US 11,555,176 ↗ Biologic patent — Jan 27, 2040
US 10,669,594 ↗ Biologic patent — Feb 12, 2037
US 11,732,025 ↗ Biologic patent — Aug 18, 2040
US 7,070,959 ↗ Biologic patent — Jun 16, 2023
US 9,222,106 ↗ Biologic patent — Jul 2, 2028
US 9,254,338 ↗ Biologic patent — May 22, 2032
US 9,669,069 ↗ Biologic patent — Jan 11, 2032
US 9,816,110 ↗ Biologic patent — Oct 21, 2035
US 10,130,681 ↗ Biologic patent — Jan 11, 2032
US D858,754 ↗ Biologic patent — Sep 3, 2034
US 10,406,226 ↗ Biologic patent — Mar 22, 2026
US 10,415,055 ↗ Biologic patent — Jun 4, 2028
US 10,464,992 ↗ Biologic patent — Jun 14, 2027
US 11,066,458 ↗ Biologic patent — Jun 14, 2027
US 10,828,345 ↗ Biologic patent — Jan 11, 2032
US 10,857,205 ↗ Biologic patent — Jan 11, 2032
US 10,857,231 ↗ Biologic patent — —
US D906,102 ↗ Biologic patent — Dec 29, 2035
US 10,888,601 ↗ Biologic patent — Jan 11, 2032
US 10,905,786 ↗ Biologic patent — Mar 6, 2038
US 10,918,754 ↗ Biologic patent — Mar 6, 2038
US 10,927,342 ↗ Biologic patent — Aug 3, 2036
US 10,973,879 ↗ Biologic patent — May 17, 2039
US 11,053,280 ↗ Biologic patent — Aug 18, 2040
US 12,054,533 ↗ Biologic patent — Aug 18, 2040
US 11,918,785 ↗ Biologic patent — Jun 29, 2037
US 11,970,724 ↗ Biologic patent — Mar 14, 2034
US 11,975,045 ↗ Biologic patent — Jan 11, 2032
US 11,986,511 ↗ Biologic patent — Jan 11, 2032
US D1,035,436 ↗ Biologic patent — Jul 16, 2039
US D1,042,107 ↗ Biologic patent — Sep 17, 2039
US 12,116,622 ↗ Biologic patent — May 25, 2038
US D1,047,700 ↗ Biologic patent — Oct 22, 2039
US 12,163,122 ↗ Biologic patent — May 10, 2042
US 12,168,036 ↗ Biologic patent — May 10, 2039
US 12,202,883 ↗ Biologic patent — Aug 18, 2040
US 11,577,025 ↗ Biologic patent — Oct 6, 2037
US 12,221,619 ↗ Biologic patent — Aug 3, 2036
US 10,961,500 ↗ Biologic patent — Jan 27, 2040
US 11,286,460 ↗ Biologic patent — Jan 27, 2040
FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateAug 18, 2035
Common questions
Is there a biosimilar for this drug?
Yes — at least one FDA-licensed biosimilar is listed for this biologic. See the Purple Book family above for the available products.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Eylea Hd — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Eylea Hd. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.98M
Claims incl. refills
805
Beneficiaries
557
Spend / beneficiary
$5,353.23
Spend / claim
$3,704.03
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61755-0051-01 You're viewing this 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-051-01) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-051-00) 2023-08-18 Active
61755-0051-51 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-051-51) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-051-50) 2023-08-18 Active

Pack size FAQ

What quantity is in NDC 61755-0051-01?
NDC 61755-0051-01 contains 1 vial — 1 vial, single-dose in 1 carton / .07 ml in 1 vial, single-dose.
What is the difference between NDC 61755-0051-01 and NDC 61755-0051-51?
Both are EYLEA HD aflibercept 8 mg/.07mL Injection, Solution — the drug itself is identical. NDC 61755-0051-01 is the 1 vial package, while NDC 61755-0051-51 is the 1 vial package.
What NDC number is used to bill for this package of EYLEA HD aflibercept 8 mg/.07mL Injection, Solution?
Bill NDC 61755-0051-01 — the 11-digit billing format is 61755005101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 61755-051-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61755-0051-01, written without dashes as 61755005101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61755-0051-01, the first segment (61755) is the labeler code FDA assigned to Regeneron Pharmaceuticals, Inc; the middle segment (0051) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Regeneron Pharmaceuticals, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (61755-0051-51). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Regeneron Pharmaceuticals, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

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🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 85 words ▾

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 ~3 min read ▾

2 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 )

2.1Important 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) ] .

2.2Neovascular (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…

💊 Dosage Forms and Strengths 51 words ▾

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 85 words ▾

4 CONTRAINDICATIONS Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 )

4.1Ocular or Periocular Infections EYLEA HD is contraindicated in patients with ocular or periocular infections.

4.2Active Intraocular Inflammation EYLEA HD is contraindicated in patients with active intraocular inflammation.

4.3Hypersensitivity 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 Cautions ~2 min read ▾

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 )

5.1Endophthalmitis, 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) ].

5.2Increase 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) ].

5.3Thromboembolic 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.

🤒 Adverse Reactions ~3 min read ▾

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 .

6.1Clinical 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…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation 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.

8.3Females 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 wit…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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 17 words ▾

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

🧓 Geriatric Use 51 words ▾

8.5Geriatric 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 34 words ▾

10 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics Increased retinal thickness, assessed by optical coherence tomography (OCT), is associated with nAMD, DME, and RVO. Reductions in central subfield thickness (CST) were observed across all treatment arms throughout the three Phase 3 studies in nAMD, DME, and RVO.

12.3Pharmacokinetics EYLEA HD is administered intravitreally to exert local effects in the eye. In patients with wet AMD, or DME, following intravitreal administration of EYLEA HD, a fraction of the administered dose is expected to bind with endogenous VEGF in the eye to form an inactive aflibercept: VEGF complex. Once absorbed into the systemic circulation, aflibercept presents in the plasma as free aflibercept (unbound to VEGF) and a more predominant stable inactive form with circulating endogenous VEGF (i.e., aflibercept: VEGF complex).

Absorption/Distribution As no relevant differences in pharmacokinetics between the nAMD, DME, and RVO populations were observed based on a population pharmacokinetic analysis of the data, population pharmacokinetic estimated parameters are presented for the combined populations. Following unilateral intravitreal administration of 8 mg aflibercept, the mean (SD) C max of free aflibercept in plasma was 0.32 (0.27) mg/L, and the median time to maximal concentration in plasma was 2.9 days. The accumulation of free aflibercept in plasma following three initial monthly intravitreal doses was minimal (mean accumulation ratio 1.2); subsequently, no further accumulation was observed.

The volume of distribution of free aflibercept following intravenous (I.V.) administration of aflibercept is approximately 7 L. Metabolism/Elimination Aflibercept is a therapeutic protein and no drug metabolism studies have been conducted. Aflibercept is expected to undergo elimination through both target-mediated disposition via binding to free endogenous VEGF and metabolism via proteolysis.

The median time to reach non-quantifiable concentrations of free aflibercept in plasma for 8 mg administered intravitreally was 3.5 weeks. Specific Populations Renal and Hepatic Impairment Population pharmacokinetic analysis revealed that systemic exposures to aflibercept in patients with mild to severe renal impairment (eGFR 15 to < 90 mL/min, estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation for eGFR were similar to those with normal renal function. Mild hepatic impairment had no influence on systemic exposures to aflibercept compared to patients with normal hepatic function .

No data for patients with moderate and severe hepatic impairment are available. No dose adjustment based on renal or hepatic impairment status is needed. Other No dosage adjustment is required for any of the populations that have been studied (e.g., age and race).

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies for other products. In the nAMD [PULSAR] and DME [PHOTON] studies, the pre-treatment incidence of anti-aflibercept antibodies in the 8 mg treatment groups wa…

🧬 Mechanism of Action 105 words ▾

12.1Mechanism 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 / Storage and Handling 167 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How 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

16.2Storage 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 and Handling 43 words ▾

16.2Storage 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.

📋 Description 160 words ▾

11 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.

💬 Information for Patients 98 words ▾

17 PATIENT COUNSELING 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61755-0050-01 · Regeneron 61755-0054-01 · Regeneron →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.