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EYLEA aflibercept 40 mg/mL Injection, Solution, 1 syringe — NDC 61755-0005-01 package photo

EYLEA aflibercept 40 mg/mL Injection, Solution, 1 syringe

by Regeneron Pharmaceuticals, Inc. · 1 SYRINGE, GLASS in 1 CARTON (61755-005-01) / .05 mL in 1 SYRINGE, GLASS
NDC 61755-0005-01
🏷️ FDA NDC (as labeled) 61755-005-01 billing pads the product segment with a zero
This package
Contains1 syringe Medicaid pays$26,707.86 / unit · 12 mo Per package$1,335.39 / 0.05 ml · Medicaid Pack sizes4 compare ↓
Also comes in: 1 vial 61755-0005-02 1 syringe 61755-0005-54 1 vial 61755-0005-55
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 6, 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

Past resolved recalls for this product (2)
Class II · May 15, 2024 · Terminated — Lack of Assurance of Sterility: Complaints of syringe breakage (Regeneron Pharmaceuticals Inc) · FDA recall D-0531-2024
Class II · Apr 23, 2024 · Terminated — Lack of Assurance of Sterility: Complaints of syringe breakage (Regeneron Pharmaceuticals Inc) · FDA recall D-0479-2024

🆔 Identity & classification

FDA NDC (as labeled) 61755-005-01
Product NDC 61755-005
11-digit billing NDC 61755000501
NCPDP billing unit ML — per mL (volume)
RxCUI 1232154, 1232159, 2693564, 2693567
UNII 15C2VL427D
Application # BLA125387
SPL Set ID f96cfd69-da34-41ee-90a9-610a4655cd1c
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 2011-11-21
Route INTRAVITREAL
Dosage form INJECTION, SOLUTION
Substance AFLIBERCEPT
GCN Seq No 071121
GCN 34816
HICL code 038209
Ingredient (HICL) Aflibercept
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q2
Therapeutic class — intermediate (HIC2) Drugs Acting On The Eye
HIC3 code Q2D
Therapeutic class — specific (HIC3) Ophth Vasc. Endothelial Growth Factor Antagonists
AHFS code 52:56.00.00
AHFS class Vascular Endothelial Growth Factor Antag
FDB label name EYLEA 2 MG/0.05 ML SYRINGE
FDB brand name Eylea
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 61755-005-01 — 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 → 61755-0005-01. 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 applicationBLA125387 (BLA)
Labeler code61755
First marketedNov 2011
Product typeHuman Prescription Drug
Portfolio27 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

Label name EYLEA 2 MG/0.05 ML SYRINGE Ingredient Aflibercept
📗 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 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII SE337SVY37
    A mineral salt used as a buffer to help maintain the medicine's pH level and prevent breakdown of active ingredients. It also acts as a thickening agent 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.

4 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 $26,707.86 $1,335.39 / 0.05 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J0178 $743.605 / J0178 unit —
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)61755-005-01
11-digit billing NDC61755-0005-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0178
DescriptorINJECTION, AFLIBERCEPT, 1 MG
Billing units / pkg40 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eylea 40 mg/mLthis 61755-0005-01 Regeneron 1 syringe — — 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

🏛️
2011
First FDA approval
Nov 2011
📍
2026
Currently FDA-listed
15 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 Nov 18, 2011

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
2011 2013 2015 2017 2019 2021 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 dateNov 18, 2023
Common questions
Is there a biosimilar for EYLEA 2 MG/0.05 ML SYRINGE?
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 61755-0005-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
124.1K
Units reimbursed last 4 qtrs
7.8K
Gross reimbursed last 4 qtrs
$208.88M
Avg / prescription
$1,683.28
Avg / unit
$26,708.25
Latest quarter Q4 2025
22.1KRx
Fee-for-service vs managed care ⓘ
50% FFS 50% MCO
Fee-for-service · 61,651 Rx Managed care · 62,441 Rx
State Medicaid map
Alaska: 8 units · 1.1 per 100k residents AK Maine: 38 units · 2.7 per 100k residents ME Washington: 299 units · 3.8 per 100k residents WA Idaho: 14 units · 0.7 per 100k residents ID Montana: 14 units · 1.2 per 100k residents MT North Dakota: 20 units · 2.6 per 100k residents ND Minnesota: 156 units · 2.7 per 100k residents MN Wisconsin: 131 units · 2.2 per 100k residents WI Michigan: 252 units · 2.5 per 100k residents MI New York: 704 units · 3.6 per 100k residents NY Vermont: 15 units · 2.3 per 100k residents VT New Hampshire: 10 units · 0.7 per 100k residents NH Oregon: 157 units · 3.7 per 100k residents OR Nevada: 62 units · 1.9 per 100k residents NV Wyoming: 8 units · 1.4 per 100k residents WY South Dakota: 9 units · 1.0 per 100k residents SD Iowa: 48 units · 1.5 per 100k residents IA Illinois: 333 units · 2.7 per 100k residents IL Indiana: 145 units · 2.1 per 100k residents IN Ohio: 225 units · 1.9 per 100k residents OH Pennsylvania: 573 units · 4.4 per 100k residents PA New Jersey: 190 units · 2.0 per 100k residents NJ Massachusetts: 364 units · 5.2 per 100k residents MA California: 704 units · 1.8 per 100k residents CA Utah: 23 units · 0.7 per 100k residents UT Colorado: 172 units · 2.9 per 100k residents CO Nebraska: 26 units · 1.3 per 100k residents NE Missouri: 126 units · 2.0 per 100k residents MO Kentucky: 156 units · 3.4 per 100k residents KY West Virginia: 64 units · 3.6 per 100k residents WV Virginia: 225 units · 2.6 per 100k residents VA Maryland: 200 units · 3.2 per 100k residents MD Connecticut: 459 units · 12.7 per 100k residents CT Rhode Island: 72 units · 6.6 per 100k residents RI Arizona: 157 units · 2.1 per 100k residents AZ New Mexico: 135 units · 6.4 per 100k residents NM Kansas: 19 units · 0.6 per 100k residents KS Arkansas: 17 units · 0.6 per 100k residents AR Tennessee: 34 units · 0.5 per 100k residents TN North Carolina: 299 units · 2.8 per 100k residents NC South Carolina: 186 units · 3.5 per 100k residents SC Delaware: 22 units · 2.1 per 100k residents DE Oklahoma: 66 units · 1.6 per 100k residents OK Louisiana: 70 units · 1.5 per 100k residents LA Mississippi: 88 units · 3.0 per 100k residents MS Alabama: 30 units · 0.6 per 100k residents AL Georgia: 216 units · 2.0 per 100k residents GA D.C.: 54 units · 8.0 per 100k residents DC Hawaii: 22 units · 1.5 per 100k residents HI Texas: 132 units · 0.4 per 100k residents TX Florida: 244 units · 1.1 per 100k residents FL
Units reimbursed · per 100k residents
0.412.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 12.7 /100k
2 D.C. 8.0 /100k
3 Rhode Island 6.6 /100k
4 New Mexico 6.4 /100k
5 Massachusetts 5.2 /100k
6 Pennsylvania 4.4 /100k
7 Washington 3.8 /100k
8 Oregon 3.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 syringe this page61755-0005-01 124,092 Rx · $208,882,197
1 vial61755-0005-02 43,970 Rx · $69,301,041
1 vial61755-0005-55 13 Rx · $6,704
1 syringe61755-0005-54 No Medicaid data
Drug total (last 4 qtrs): 168,075 Rx · 10,406 units · $278,189,942 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Eylea — 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. 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
$10.8M
Claims incl. refills
4.1K
Beneficiaries
2.6K
Spend / beneficiary
$4,186.77
Spend / claim
$2,639.75
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for EYLEA (this brand).

Top reported reactions

Death7,868
Visual Impairment2,004
Blindness1,427
Endophthalmitis1,336
Visual Acuity Reduced1,228
Eye Pain1,151
Vision Blurred1,129

Reporter sex

0 reports

Serious outcomes

Death8,868
Disabling1,989
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,417 905
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61755-0005-01 You're viewing this 1 SYRINGE, GLASS in 1 CARTON (61755-005-01) / .05 mL in 1 SYRINGE, GLASS 2019-12-09 Active
61755-0005-02 1 VIAL, SINGLE-USE in 1 CARTON (61755-005-02) / .05 mL in 1 VIAL, SINGLE-USE 2011-11-21 Active
61755-0005-54 1 SYRINGE, GLASS in 1 CARTON (61755-005-54) / .05 mL in 1 SYRINGE, GLASS 2019-12-09 Active
61755-0005-55 1 VIAL, SINGLE-USE in 1 CARTON (61755-005-55) / .05 mL in 1 VIAL, SINGLE-USE 2014-01-16 Active

In Medicaid, this is the most-dispensed pack of this product — about 74% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 61755-0005-01?
NDC 61755-0005-01 contains 1 syringe — 1 syringe, glass in 1 carton / .05 ml in 1 syringe, glass.
What is the difference between NDC 61755-0005-01 and NDC 61755-0005-02?
Both are EYLEA aflibercept 40 mg/mL Injection, Solution — the drug itself is identical. NDC 61755-0005-01 is the 1 syringe package, while NDC 61755-0005-02 is the 1 vial package.
What NDC number is used to bill for this package of EYLEA aflibercept 40 mg/mL Injection, Solution?
Bill NDC 61755-0005-01 — the 11-digit billing format is 61755000501. 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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 61755-005-01, 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: 61755-0005-01, written without dashes as 61755000501. 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 61755-0005-01, the first segment (61755) is the labeler code FDA assigned to Regeneron Pharmaceuticals, Inc.; the middle segment (0005) 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 3 other package presentations of this same product, including 1 vial (61755-0005-02), 1 syringe (61755-0005-54), 1 vial (61755-0005-55). 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0178 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 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 95 words ▾

1 INDICATIONS AND USAGE EYLEA is indicated for the treatment of: EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) Diabetic Macular Edema (DME) ( 1.3 ) Diabetic Retinopathy (DR) ( 1.4 ) Retinopathy of Prematurity (ROP) ( 1.5 )

1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD)

1.2 Macular Edema Following Retinal Vein Occlusion (RVO)

1.3 Diabetic Macular Edema (DME)

1.4 Diabetic Retinopathy (DR)

1.5 Retinopathy of Prematurity (ROP)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Neovascular (Wet) Age-Related Macular Degeneration (AMD) The recommended dose for EYLEA is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months). ( 2.5 ) Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks.

Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months). ( 2.5 ) Although not as effective as the recommended every 8 week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly.

( 2.5 ) Macular Edema Following Retinal Vein Occlusion (RVO) The recommended dose for EYLEA is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection once every 4 weeks (approximately every 25 days, monthly). ( 2.6 ) Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) The recommended dose for EYLEA is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months).

( 2.7 , 2.8 ) Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months). (2.7 , 2.8 ) Retinopathy of Prematurity (ROP) The recommended dose for EYLEA is 0.4 mg (0.01 mL or 10 microliters of 40 mg/mL solution) administered by intravitreal injection.

Treatment may be given bilaterally on the same day. Injections may be repeated in each eye. The treatment interval between doses injected into the same eye should be at least 10 days.

( 2.9 )

2.1Important Injection Instructions For ophthalmic intravitreal injection. EYLEA must only be administered by a qualified physician. Pre-filled Syringe: A 30-gauge × ½-inch sterile injection needle is needed but not provided.

Vial: 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 is available packaged as follows: Pre-filled Syringe Vial Kit with Injection Components (filter needle, syringe, injection needle) [see How Supplied/Storage and Handling (16) ].

2.2Preparation for Administration – Pre-filled Syringe The EYLEA pre-filled glass syringe is sterile and for one-time use in one eye only. Do not use the EYLEA pre-filled syringe for the treatment of ROP. The pre-filled syringe should be inspected visually prior to administration.

Do not use if particulates, cloudiness, or discoloration are visible, or if the package is open or damaged. The appearance of the syringe cap on the pre-filled syringe may vary (for example, color and design). Do not use if any part of the pre-filled syringe is damaged or if the syringe cap is detached from the Luer lock.

The intravitreal injection should be performed with a 30-gauge × ½-inch injection needle (not provided). The pre-filled syringe contains more than the recommended dose of 2 mg aflibercept (equivalent to 50 microliters). The excess volume must be discarded prior to the administration.

PRE-FILLED SYRINGE DESCRIPTION – Figure 1: Use aseptic technique to carry out the following steps: 1. PREPARE When ready to administer EYLEA, open the carton and remove sterilized blister pack. Carefully peel open the sterilized blister pack ensuring the sterility of its contents.

Keep the syringe in the sterile tray until you are ready for assem…

💊 Dosage Forms and Strengths 80 words ▾

3 DOSAGE FORMS AND STRENGTHS EYLEA is a clear, colorless to pale yellow solution available as: Injection: 2 mg (0.05 mL of a 40 mg/mL solution) in a single-dose pre-filled glass syringe Injection: 2 mg (0.05 mL of a 40 mg/mL solution) in a single-dose glass vial Injection: 2 mg (0.05 mL of 40 mg/mL) solution in a single-dose pre-filled syringe ( 3 ) Injection: 2 mg (0.05 mL of 40 mg/mL) solution in a single-dose vial ( 3 )

⛔ Contraindications 81 words ▾

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

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

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

4.3Hypersensitivity EYLEA is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in EYLEA. 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 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. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.

( 5.2 ) In infants with ROP, treatment with EYLEA will necessitate extended periods of ROP monitoring ( 5.3 ) There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ( 5.4 )

5.1Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion Intravitreal injections, including those with EYLEA, 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. 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 (2.4) 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 [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 (2.4) ].

5.3Extended Monitoring and Additional Treatment in ROP Reactivation of abnormal angiogenesis and tortuosity may occur following treatment with EYLEA. Infants should be monitored closely after injection with EYLEA until retinal vascularization has completed or until the examiner is assured that reactivation of ROP will not occur. In infants with ROP, treatment with EYLEA will necessitate extended periods of ROP monitoring and additional EYLEA injections and/or laser treatments may be necessary.

5.4Thromboembolic Events There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group.

The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.

🤒 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 (5.4) ] The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.

( 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 2980 adult patients treated with EYLEA constituted the safety population in eight phase 3 studies. Among those, 2379 patients were treated with the recommended dose of 2 mg.

Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment. The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. Neovascular (Wet) Age-Related Macular Degeneration (AMD) The data described below reflect exposure to EYLEA in 1824 patients with wet AMD, including 1223 patients treated with the 2-mg dose, in 2 double-masked, controlled clinical studies (VIEW1 and VIEW2) for 24 months (with active control in year 1) [see Clinical Studies (14.1) ].

Safety data observed in the EYLEA group in a 52-week, double-masked, Phase 2 study were consistent with these results. Table 1: Most Common Adverse Reactions (≥1%) in Wet AMD Studies Adverse Reactions Baseline to Week 52 Baseline to Week 96 EYLEA (N=1824) Active Control (ranibizumab) (N=595) EYLEA (N=1824) Control (ranibizumab) (N=595) Conjunctival hemorrhage 25% 28% 27% 30% Eye pain 9% 9% 10% 10% Cataract 7% 7% 13% 10% Vitreous detachment 6% 6% 8% 8% Vitreous floaters 6% 7% 8% 10% Intraocular pressure increased 5% 7% 7% 11% Ocular hyperemia 4% 8% 5% 10% Corneal epithelium defect 4% 5% 5% 6% Detachment of the retinal pigment epithelium 3% 3% 5% 5% Injection site pain 3% 3% 3% 4% Foreign body sensation in eyes 3% 4% 4% 4% Lacrimation increased 3% 1% 4% 2% Vision blurred 2% 2% 4% 3% Intraocular inflammation 2% 3% 3% 4% Retinal pigment epithelium tear 2% 1% 2% 2% Injection site hemorrhage 1% 2% 2% 2% Eyelid edema 1% 2% 2% 3% Corneal edema 1% 1% 1% 1% Retinal detachment <1% <1% 1% 1% Less common serious adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal tear, and endophthalmitis.

Macular Edema Following Retinal Vein Occlusion (RVO) The data described below reflect 6 months exposure to EYLEA with a monthly 2 mg dose in 218 patients following central retinal vein occlusion (CRVO) in 2 clinical studies (COPERNICUS and GALILEO) and 91 patients following branch retinal vein occlusion (BRVO) in one clinical study (VIBRANT) [see Clinical Studies (14.2) , (14.3) ]. Table 2: Most Common Adverse Reactions (≥1%) in RVO Studies Adverse Reactions CRVO BRVO EYLEA (N=218) Control (N=142) EYLEA (N=91) Control (N=92) Eye pain 13% 5% 4% 5% Conjunctival hemorrhage 12% 11% 20% 4% Intraocular pressure increased 8% 6% 2% 0% Corneal epithelium defect 5% 4% 2% 0% Vitreous floaters 5% 1% 1% 0% Ocular hyperemia 5% 3% 2% 2% Foreign body sensation in eyes 3% 5% 3% 0% Vitreous detachment 3% 4% 2% 0% Lacrimation increased 3% 4% 3% 0% Injection site pain 3% 1% 1% 0% Vision blurred 1% <1% 1% 1%…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Adequate and well-controlled studies with EYLEA 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 exposures (based on AUC for free aflibercept) were approximately 6 times higher than AUC values observed in humans after a single intravitreal treatment at the recommended clinical dose [see Animal Data ]. Animal reproduction studies are not always predictive of human response, and it is not known whether EYLEA 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 may pose a risk to human embryofetal development.

EYLEA 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 6 times higher than systemic exposure (AUC) observed in adult patients after a single intravitreal dose of 2 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 is not recommended during breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EYLEA and any potential adverse effects on the breastfed child from EYLEA.

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 3 months after the last intravitreal injection of EYLEA. Infertility There are no data regarding the effects of EYLEA on human fertility. Aflibercept adversely affected female and male reproductive systems in cynomolgus monkeys when administered by intravenous injection at a dose approximately 1500 times higher than the systemic level observed in adult patients with an intravitreal dose of 2 mg.

A No Observed Adverse Effect Level (NOAEL) was not identified. These findings were reversible within 20 weeks after cessation of treatment [see Nonclinical Toxicology (13.1) ].

8.4 Pediatric…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Adequate and well-controlled studies with EYLEA 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 exposures (based on AUC for free aflibercept) were approximately 6 times higher than AUC values observed in humans after a single intravitreal treatment at the recommended clinical dose [see Animal Data ]. Animal reproduction studies are not always predictive of human response, and it is not known whether EYLEA 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 may pose a risk to human embryofetal development.

EYLEA 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 6 times higher than systemic exposure (AUC) observed in adult patients after a single intravitreal dose of 2 mg.

🧒 Pediatric Use 76 words ▾

8.4Pediatric Use The safety and effectiveness of EYLEA have been demonstrated in two clinical studies of pre-term infants with ROP. These two studies randomized pre-term infants between initial treatment with EYLEA or laser. Efficacy of each treatment is supported by the demonstration of a clinical course which was better than would have been expected without treatment [see Dosage and Administration (2.9) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Studies (14.6) ] .

🧓 Geriatric Use 46 words ▾

8.5Geriatric Use In the clinical studies, approximately 76% (2049/2701) of patients randomized to treatment with EYLEA were ≥65 years of age and approximately 46% (1250/2701) were ≥75 years of age. No significant differences in efficacy or safety were seen with increasing age in these studies.

🆘 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 Neovascular (Wet) Age-Related Macular Degeneration (AMD) In the clinical studies anatomic measures of disease activity improved similarly in all treatment groups from baseline to week 52. Anatomic data were not used to influence treatment decisions during the first year. Macular Edema Following Retinal Vein Occlusion (RVO) Reductions in mean retinal thickness were observed in COPERNICUS, GALILEO, and VIBRANT at week 24 compared to baseline.

Anatomic data were not used to influence treatment decisions [see Clinical Studies (14.2) , (14.3) ]. Diabetic Macular Edema (DME) Reductions in mean retinal thickness were observed in VIVID and VISTA at weeks 52 and 100 compared to baseline. Anatomic data were not used to influence EYLEA treatment decisions [see Clinical Studies (14.4) ].

12.3Pharmacokinetics EYLEA is administered intravitreally to exert local effects in the eye. In patients with wet AMD, RVO, or DME, following intravitreal administration of EYLEA, 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 Following intravitreal administration of 2 mg per eye of EYLEA to patients with wet AMD, RVO, and DME, the mean C max of free aflibercept in the plasma was 0.02 mcg/mL (range: 0 to 0.054 mcg/mL), 0.05 mcg/mL (range: 0 to 0.081 mcg/mL), and 0.03 mcg/mL (range: 0 to 0.076 mcg/mL), respectively and was attained in 1 to 3 days. The free aflibercept plasma concentrations were undetectable two weeks post-dosing in all patients. Aflibercept did not accumulate in plasma when administered as repeated doses intravitreally every 4 weeks.

It is estimated that after intravitreal administration of 2 mg to patients, the mean maximum plasma concentration of free aflibercept is more than 100 fold lower than the concentration of aflibercept required to half-maximally bind systemic VEGF. The volume of distribution of free aflibercept following intravenous (I.V.) administration of aflibercept has been determined to be approximately 6L. 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 terminal elimination half-life (t1/2) of free aflibercept in plasma was approximately 5 to 6 days after I.V. administration of doses of 2 to 4 mg/kg aflibercept. Specific Populations Pediatric Patients Pharmacokinetics of aflibercept were evaluated in pre-term infants with ROP at a dose of 0.4 mg aflibercept (per eye) administered unilaterally or bilaterally.

In the BUTTERFLEYE study, mean concentrations of free aflibercept in plasma declined from a maximum of 0.583 mcg/mL at Day 1 to 0.0406 mcg/mL at Day 28 in bilaterally treated patients. In the FIREFLEYE study, mean concentrations of free aflibercept in plasma for all patients (bilateral and unilateral administration combined) d…

🧬 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 186 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Each pre-filled syringe or vial is a clear, colorless to pale yellow solution and is for single eye use only. EYLEA is supplied in the following presentations [see Dosage and Administration (2.1) , (2.2) , (2.3) , (2.4) and (2.9) ]. Discard unused portion.

NDC NUMBER CARTON TYPE CARTON CONTENTS 61755-005-01 Pre-filled Syringe one blister pack containing one EYLEA 2 mg (0.05 mL of a 40 mg/mL solution) sterile, single-dose pre-filled glass syringe one Prescribing Information 61755-005-02 Vial Kit with Injection Components one EYLEA 2 mg (0.05 mL of a 40 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

16.2Storage and Handling Refrigerate EYLEA 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. Do not open sealed blister tray until time of use.

📦 Storage and Handling 52 words ▾

16.2Storage and Handling Refrigerate EYLEA 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. Do not open sealed blister tray until time of use.

📋 Description 169 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 with a protein molecular weight of 97 kilodaltons (kDa) 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 (aflibercept) Injection is a sterile, clear, and colorless to pale yellow solution. EYLEA does not contain anti-microbial preservative and is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose pre-filled glass syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept in polysorbate 20 (0.015 mg), sodium chloride (0.117 mg), sodium phosphate monobasic monohydrate (0.055 mg), sodium phosphate dibasic heptahydrate (0.027 mg), sucrose (2.5 mg) and water for injection with a pH of 6.2.

💬 Information for Patients 110 words ▾

17 PATIENT COUNSELING INFORMATION In the days following EYLEA 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 and the associated eye examinations [see Adverse Reactions (6) ] .

Advise patients not to drive or use machinery until visual function has recovered sufficiently. In infants with ROP, treatment with EYLEA will necessitate extended periods of ROP monitoring.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61748-0054-16 · Akorn 61755-0008-01 · 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.