Home › NDC Lookup › Ingredients › Pegfilgrastim › 55513-0192-01
Neulasta pegfilgrastim Kit — NDC 55513-0192-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Neulasta pegfilgrastim Kit — NDC 55513-192-01 (Billing 55513-0192-01)

by Amgen, Inc · 1 KIT in 1 CARTON * .6 mL in 1 SYRINGE

This is a package of Neulasta pegfilgrastim Kit from Amgen, Inc, marketed since Apr 2002 and currently FDA-listed. It is this product's only package size.

NDC 55513-0192-01
🏷️ FDA NDC (as labeled) 55513-192-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55513-192-01
Product NDC 55513-192
11-digit billing NDC 55513019201
NCPDP billing unit ML — per mL (volume)
RxCUI 727539, 727542, 2549331, 2549333, 2739503, 2739504
UNII 3A58010674
Application # BLA125031
SPL Set ID fdfe5d72-6b80-435a-afa4-c5d74dd852ce
Established class (EPC) Leukocyte Growth Factor
Physiologic effect Increased Myeloid Cell Production
Chemical class Granulocyte Colony-Stimulating Factor
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-04-01
Dosage form KIT
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 073319
GCN 37706
HICL code 023255
Ingredient (HICL) Pegfilgrastim
HIC1 code N
Therapeutic class — broad (HIC1) Bone Marrow
HIC2 code N1
Therapeutic class — intermediate (HIC2) Affecting Blood, Non-Iron Hematinics And Others
HIC3 code N1C
Therapeutic class — specific (HIC3) Leukocyte (Wbc) Stimulants
AHFS code 20:16.00.00
AHFS class Hematopoietic Agents
FDB label name NEULASTA ONPRO 6 MG/0.6 ML KIT
FDB brand name Neulasta Onpro
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073319
  • GCN: 37706
  • HICL (First Databank): 023255
  • AHFS class code: 20:16.00.00
  • RxCUI (RxNorm): 727539
Why two NDCs? The FDA registers this code as 55513-192-01 — 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 → 55513-0192-01. 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 Leukocyte Growth Factor class.

Pharmacologic class Leukocyte Growth Factor
Drug family (ATC) Colony stimulating factors
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.

Clinical

Label name NEULASTA ONPRO 6 MG/0.6 ML KIT Ingredient Pegfilgrastim
📖 What it is MedlinePlus · NLM

Pegfilgrastim injection products are used to reduce the chance of infection in people who have certain types of cancer and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection). Pegfilgrastim injectionis also used to increase the chance of survival in people who have been exposed to harmful amounts of radiation, which can cause severe and life-threatening damage to bone marrow. Pegfilgrastim is in a class of medications called colony stimulating factors. It works by helping the body make more neutrophils.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps lower the risk of serious infection with fever in people with non-myeloid cancers getting chemotherapy. Neulasta is also used to improve survival after exposure to dangero...
  • For chemotherapy, Neulasta is given once per cycle. It is not given in the 14 days before or the 24 hours after chemotherapy. Your care team will set the exact timing.
  • Bone pain and pain in the arms or legs are the most common. Rash, flushing and injection site reactions can also happen.
  • Get help for trouble breathing, facial swelling, or hives. Also report pain in the left upper belly or shoulder, fever with breathing problems, or a sickle cell crisis.
📖 Read our full Pegfilgrastim 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.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $4,836.83 —
Medicare drug plans payPart D · Q2 2026 $10,634.70 —
Medicare Part B allowsASP · J2506 $143.233 / J2506 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)55513-192-01
11-digit billing NDC55513-0192-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2506
DescriptorINJECTION, PEGFILGRASTIM, EXCLUDES BIOSIMILAR, 0.5 MG
Billing units / pkg20 units
How the units are derivedThis package is 0.6 ML; the HCPCS unit is 0.5 MG, so one package = 20 billing units.
Medicare Part B spend (2026 (Q1))$31,452,186 · 20,607 claims · $1,526.29 per claim (all NDCs under J2506)
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55513-0192-01 You're viewing this Main listing 1 KIT in 1 CARTON * .6 mL in 1 SYRINGE 2015-02-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Neulastathis 55513-0192-01 Amgen, 1 kit — — 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

🏛️
2002
First FDA approval
Jan 2002
📍
2026
Currently FDA-listed
24 years listed
🔓
2026
Biosimilars listed
8 FDA-licensed
🧬FDA-licensed biosimilars listed

8 biosimilars 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 Jun 2030.
📅 FDA approved Jan 31, 2002

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
Neulastapegfilgrastim Neulasta Onpropegfilgrastim
Biosimilars 8
Armlupegpegfilgrastim-unne Fulphilapegfilgrastim-jmdb Fylnetrapegfilgrastim-pbbk Nyvepriapegfilgrastim-apgf Stimufendpegfilgrastim-fpgk Udenycapegfilgrastim-cbqv Udenyca Onbodypegfilgrastim-cbqv Ziextenzopegfilgrastim-bmez
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
US 9,856,287 — biologic patent
2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030
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 (1)
PatentTypeUse codeExpires
US 9,856,287 ↗ Biologic patent — Jun 21, 2030
Common questions
Is there a biosimilar for NEULASTA ONPRO 6 MG/0.6 ML KIT?
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.

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.

The FDA label contains product information, but this exact NDC could not be matched safely to one product block. We intentionally withheld sibling strengths’ ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerAmgen, Inc
FDA applicationBLA125031 (BLA)
Labeler code55513
First marketedApr 2002
Product typeHuman Prescription Drug
Portfolio81 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 196 words ▾

1 INDICATIONS AND USAGE Neulasta is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

1.1Patients with Cancer Receiving Myelosuppressive Chemotherapy Neulasta is indicated in adult and pediatric patients to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1) ] . Limitations of Use Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

1.2Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Neulasta is indicated to increase survival in adults and pediatric patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Patients with cancer receiving myelosuppressive chemotherapy For adult patients of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is 6 mg subcutaneously once per chemotherapy cycle. ( 2.1 ) For pediatric patients weighing less than 45 kg, use weight-based dosing; refer to Table 1. ( 2.1 ) Do not administer between 14 days before and 24 hours after administration of chemotherapy.

( 2.1 ) Patients acutely exposed to myelosuppressive doses of radiation For adults of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is two doses, 6 mg each, subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after. ( 2.2 ) For pediatric patients weighing less than 45 kg, use weight-based dosing; refer to Table 1.

( 2.1 )

2.1Patients with Cancer Receiving Myelosuppressive Chemotherapy The recommended dosage of Neulasta for adults of any weight and pediatric patients weighing at least 45 kg with cancer receiving myelosuppressive chemotherapy is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administer Neulasta between 14 days before and 24 hours after administration of chemotherapy.

Table 1. Dosing of Neulasta for Pediatric Patients Weighing Less Than 45 kg Body Weight Neulasta Dose Volume to Administer Less than 10 kg For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of Neulasta. See below See below 10 kg to 20 kg 1.5 mg 0.15 mL 21 kg to 30 kg 2.5 mg 0.25 mL 31 kg to 44 kg 4 mg 0.4 mL

2.2Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome The recommended dosage of Neulasta for adults of any weight and pediatric patients weighing at least 45 kg with hematopoietic subsyndrome of acute radiation syndrome is two doses, 6 mg each, administered subcutaneously one week apart. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1 [see Dosage and Administration (2.1) ] . Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy).

Administer the second dose one week after the first dose. Obtain a baseline complete blood count (CBC). Do not delay administration of Neulasta if a CBC is not readily available.

Estimate a patient's absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.

2.3Preparation and Administration Neulasta is supplied in single-dose prefilled syringes for manual use or for use with the on-body injector (OBI) for Neulasta, which is co-packaged with a single-dose prefilled syringe for the OBI, and in single-dose vials [see Dosage Forms and Strengths (3) ] . Before using any of the Neulasta presentations: Remove the carton from the refrigerator and allow the Neulasta prefilled syringe or vial to reach room temperature, 20°C to 25°C (68°F to 77°F), for a minimum of 30 minutes. Do not warm in any other way.

Discard any prefilled syringe or vial left at room temperature for greater than 48 hours. Neulasta is a clear, colorless, preservative-free solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not administer Neulasta if discoloration or particulates are observed. Prefilled Syringe for Manual Use For adult patients of any weight and pediatric patients weighing 45 kg and greater, the single-dose prefilled syringe for manual use is intended for subcutaneous administration of a single 6 mg/0.6 mL dose of Neulasta. The syringe does not bear graduation marks and therefore does… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 104 words ▾

3 DOSAGE FORMS AND STRENGTHS Neulasta is a clear, colorless, preservative-free solution available as: Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only. Injection: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector (OBI) for Neulasta (Neulasta Onpro kit). Injection: 4 mg/0.4 mL in a single-dose vial.

Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe for manual use only. ( 3 ) Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe co-packaged with the on-body injector for Neulasta. ( 3 ) Injection: 4 mg/0.4 mL solution in a single-dose vial.

( 3 )

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS Neulasta is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim or filgrastim. Reactions have included anaphylaxis [see Warnings and Precautions (5.3) ] . In patients with a history of serious hypersensitivity reaction to pegfilgrastim or filgrastim. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. ( 5.1 ) Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Neulasta in patients with ARDS.

( 5.2 ) Serious hypersensitivity reactions, including anaphylaxis: Permanently discontinue Neulasta in patients with serious hypersensitivity reactions. ( 5.3 ) The on-body injector for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

( 5.4 ) Fatal sickle cell crises: Discontinue Neulasta if sickle cell crisis occurs. ( 5.5 ) Glomerulonephritis: Evaluate and consider dose-reduction or interruption of Neulasta if causality is likely. ( 5.6 ) Thrombocytopenia: Monitor platelet counts.

( 5.8 ) Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using Neulasta in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. ( 5.11 ) Potential device failures: Instruct patients to notify their healthcare provider if they suspect the on-body injector may not have performed as intended. ( 5.12 ) Large and Medium Vessel Arteritis: Discontinue Neulasta if arteritis is suspected.

( 5.13 )

5.1Splenic Rupture Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

5.2Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta, for ARDS. Discontinue Neulasta in patients with ARDS.

5.3Serious Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Hypersensitivity reactions, including anaphylaxis, can recur within days after the discontinuation of initial therapies to manage the reaction.

Permanently discontinue Neulasta in patients with serious hypersensitivity reactions. Neulasta is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim or filgrastim.

5.4Allergies to Acrylics The on-body injector (OBI) for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

5.5Use in Patients with Sickle Cell Disorders Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Discontinue Neulasta if sickle cell crisis occurs.

5.6Glomerulonephritis Glomerulonephritis has occurred in patients receiving Neulasta. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of Neulasta. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Neulasta.

5.7Leukocytosis White blood cell (WBC) counts of 100 × 10 9 /L or greater have been observed in patients receiving Neulasta. Monitoring of complete blood count (CBC) during Neulasta therapy is recommended.

5.8Thrombocytopenia Neulasta can cause thrombocytopenia. Monitor platelet counts during Neulasta therapy.

5.9Capillary Leak Syndrome Capillary leak syndrome has been reported after G-CSF administration, including Neulasta, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Allergies to Acrylics [see Warnings and Precautions (5.4) ] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions (5.5) ] Glomerulonephritis [see Warnings and Precautions (5.6) ] Leukocytosis [see Warnings and Precautions (5.7) ] Thrombocytopenia [see Warnings and Precautions (5.8) ] Capillary Leak Syndrome [see Warnings and Precautions (5.9) ] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.10) ] Myelodysplastic syndrome [see Warnings and Precautions (5.11) ] Acute myeloid leukemia [see Warnings and Precautions (5.11) ] Large and Medium Vessel Arteritis [see Warnings and Precautions (5.13) ] Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) 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 with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Neulasta clinical trials safety data are based upon 932 patients receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female.

The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received Neulasta after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.

The following adverse reaction data in Table 2 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m 2 every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female.

The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and < 1% Asian, Native American, or other. The most common adverse reactions occurring in ≥ 5% of patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim arm in placebo-controlled clinical trials are bone pain and pain in extremity. Table 2.

Adverse Reactions with ≥ 5% Higher Incidence in Neulasta Patients Compared to Placebo in Study 3 Body System Adverse Reaction Placebo (N = 461) Neulasta 6 mg SC on Day 2 (N = 467) Musculoskeletal and connective tissue disorders Bone pain 26% 31% Pain in extremity 4% 9% Leukocytosis In clinical studies, leukocytosis (WBC counts > 100 × 10 9 /L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies.

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Splenic rupture and splenomegaly (enlarged spleen) [see Warnings and Precautions (5.1) ] Acute respiratory distress syndrome (ARDS) [see Warnings and Precautions (5.2) ] Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, urticaria, generalized erythema, and flushing [see Warnings and Precautions (5.3) ] Sickle c… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Although available data with Neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area).

In pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study.

Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation.

No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).

8.2Lactation Risk Summary There are no data on the presence of pegfilgrastim in human milk, the effects on the breastfed child, or the effects on milk production. Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neulasta and any potential adverse effects on the breastfed child from Neulasta or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Neulasta for chemotherapy-induced neutropenia and hematopoietic subsyndrome of acute radiation syndrome have been established in pediatric patients. Use of Neulasta in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 8 months and older with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ] . The use of Neulasta to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on efficacy studies cond… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Although available data with Neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area).

In pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study.

Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation.

No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).

🧒 Pediatric Use 181 words ▾

8.4Pediatric Use The safety and effectiveness of Neulasta for chemotherapy-induced neutropenia and hematopoietic subsyndrome of acute radiation syndrome have been established in pediatric patients. Use of Neulasta in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 8 months and older with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ] . The use of Neulasta to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on efficacy studies conducted in animals and clinical data supporting the use of Neulasta in patients with cancer receiving myelosuppressive chemotherapy.

Efficacy studies of Neulasta could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Results from population modeling and simulation indicate that two doses of Neulasta (Table 1), administered one week apart provide pediatric patients with exposures comparable to that in adults receiving two 6 mg doses one week apart [see Dosage and Administration (2.1 , 2.2) , Clinical Pharmacology (12.3) and Clinical Studies (14.2) ] .

🧓 Geriatric Use 48 words ▾

8.5Geriatric Use Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. No overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

🆘 Overdosage 70 words ▾

10 OVERDOSAGE Overdosage of Neulasta may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered Neulasta on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6) ] .

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

12.2Pharmacodynamics Animal data and clinical data in humans suggest a correlation between pegfilgrastim exposure and the duration of severe neutropenia as a predictor of efficacy. Selection of the dosing regimen of Neulasta is based on reducing the duration of severe neutropenia.

12.3Pharmacokinetics The pharmacokinetics of pegfilgrastim was studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim was nonlinear, and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils.

In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed.

The half-life of Neulasta ranged from 15 to 80 hours after subcutaneous injection. In healthy volunteers, the pharmacokinetics of pegfilgrastim were comparable when delivered subcutaneously via a manual prefilled syringe versus via the on-body injector (OBI) for Neulasta. Specific Populations No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥ 65 years of age) compared with younger patients (< 65 years of age) [see Use in Specific Populations (8.5) ] .

Renal Impairment In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. Pediatric Patients with Cancer Receiving Myelosuppressive Chemotherapy The pharmacokinetics and safety of pegfilgrastim were studied in 37 pediatric patients with sarcoma in Study 4 [see Clinical Studies (14.1) ] . The mean (± standard deviation [SD]) systemic exposure (AUC 0-inf ) of Neulasta after subcutaneous administration at 100 mcg/kg was 47.9 (± 22.5) mcg ∙ hr/mL in the youngest age group (0 to 5 years, n = 11), 22.0 (± 13.1) mcg ∙ hr/mL in the 6 to 11 years age group (n = 10), and 29.3 (± 23.2) mcg ∙ hr/mL in the 12 to 21 years age group (n = 13).

The terminal elimination half-lives of the corresponding age groups were 30.1 (± 38.2) hours, 20.2 (± 11.3) hours, and 21.2 (± 16.0) hours, respectively. Patients Acutely Exposed to Myelosuppressive Doses of Radiation The pharmacokinetics of pegfilgrastim is not available in patients acutely exposed to myelosuppressive doses of radiation. Based on limited pharmacokinetic data in irradiated non-human primates, the area under the concentration-time curve (AUC), reflecting the exposure to pegfilgrastim in non-human primates following a 300 mcg/kg dose of Neulasta, appears to be greater than in humans receiving a 6 mg dose.

Results from population modeling and simulation indicate that two 6 mg doses of Neulasta administered one week apart in adults result in clinically relevant effects on duration of grade 3 and 4 neutropenia. In addition, weight-based dosing in pediatric patients weighing less than 45 kg [see Dosage and Administration (2.1 , Table 1 and 2.2) ] provides exposures comparable to those in adults receiving two 6 mg doses one week apart.

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 in other studies, including those of pegfilgrastim or of other pegfilgrastim products.… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 31 words ▾

12.1Mechanism of Action Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Neulasta single-dose prefilled syringe for manual use Neulasta injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe ® Needle Guard. The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex). Neulasta is provided in a carton containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 55513-190-01).

Neulasta prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light or physical damage. Discard syringes stored at room temperature for more than 48 hours.

Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once. Do not shake.

Neulasta Onpro ® kit Neulasta Onpro kit is provided in a carton containing one sterile prefilled syringe and one sterile on-body injector (OBI) for Neulasta (NDC 55513-192-01). The Neulasta injection single-dose prefilled syringe contains 0.64 mL of a clear, colorless solution that delivers 6 mg/0.6 mL of pegfilgrastim when used with the OBI for Neulasta. The prefilled syringe is supplied with a 27-gauge, 1/2-inch needle.

The syringe does not bear graduation marks and is only to be used with the OBI for Neulasta. The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex). Store Neulasta Onpro kit refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

Because the OBI for Neulasta is at room temperature during the period of use, Neulasta Onpro kit should not be held at room temperature longer than 12 hours prior to use. Discard Neulasta Onpro kit if stored at room temperature for more than 12 hours. Do not freeze the kit.

Do not shake the prefilled syringe. Do not use the OBI for Neulasta if its packaging has been previously opened. Neulasta single-dose vial Neulasta injection is a clear, colorless, solution, supplied in a vial containing 4 mg pegfilgrastim.

Neulasta is provided in a carton containing one 4 mg/0.4 mL vial (NDC 55513-099-01). Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.

Discard vials stored at room temperature for more than 48 hours. Do not shake.

📦 Storage and Handling 34 words ▾

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Discard vials stored at room temperature for more than 48 hours. Do not shake.

📋 Description ~1 min read ▾

11 DESCRIPTION Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E. coli transformed with a genetically engineered plasmid containing the human G-CSF gene.

To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD. Neulasta (pegfilgrastim) is a sterile, clear, colorless, preservative-free solution with a pH of 4.0, supplied in single-dose prefilled syringes for manual use or for use with the on-body injector (OBI) for Neulasta, which is co-packaged with a single-dose prefilled syringe, or in single-dose vials.

Prefilled Syringe for Manual Use or for Use with OBI Neulasta for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). On-body injector (OBI) for Neulasta is supplied with a prefilled syringe containing 0.64 mL of Neulasta in solution that delivers 0.6 mL of Neulasta in solution when used with the OBI for Neulasta.

The syringe does not bear graduation marks and is only to be used with the OBI for Neulasta. The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection or the OBI for Neulasta contains pegfilgrastim (6 mg based on protein weight), acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP. Vial Neulasta for subcutaneous injection is supplied in 4 mg/0.4 mL single-dose vials.

Each 0.4 mL vial contains pegfilgrastim (4 mg based on protein weight), acetate (0.24 mg), polysorbate 20 (0.02 mg), sodium (0.01 mg), and sorbitol (20 mg) in Water for Injection, USP.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Advise patients of the following risks and potential risks with Neulasta: Splenic rupture and splenomegaly Acute Respiratory Distress Syndrome Serious hypersensitivity reactions Sickle cell crisis Glomerulonephritis Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive Neulasta in conjunction with chemotherapy and/or radiation therapy Capillary Leak Syndrome Arteritis, including aortitis Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of Neulasta for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.2) ] .

Instruct patients who self-administer Neulasta using the prefilled syringe of the: Importance of following the Instructions for Use. Dangers of reusing syringes. Importance of following local requirements for proper disposal of used syringes.

Advise patients on the use of the on-body injector (OBI) for Neulasta: Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient. Refer the patient to the dose delivery information written on the Patient Instructions for Use. Tell the patient when their dose delivery of Neulasta will begin and when their dose delivery should be completed.

Advise the patient that serious hypersensitivity reactions can happen with Neulasta. Patients should have a caregiver nearby for the first use. Patients should plan to be in a place where they can appropriately monitor the OBI for Neulasta during the approximately 45 minute Neulasta delivery and for an hour after the delivery.

Advise the patient to avoid traveling, driving, or operating heavy machinery during hours 26 to 29 following application of the OBI for Neulasta. If the OBI for Neulasta is placed on the back of the arm, remind the patient that a caregiver must be available to monitor the OBI for Neulasta. If a patient calls the healthcare provider regarding any OBI for Neulasta problems, the healthcare provider is advised to call Amgen at 1-800-772-6436.

Advise the patient: to call their healthcare provider immediately if the status light on the OBI for Neulasta is flashing red (see the Patient Instructions for Use) . to inform their healthcare provider if the adhesive on the OBI for Neulasta becomes saturated with fluid, or there is dripping, as this may be evidence of significant product leakage, resulting in inadequate or missed dose (see the Patient Instructions for Use) . to keep the OBI for Neulasta dry for approximately the last 3 hours prior to the dose delivery start to better enable potential leak detection. that the OBI for Neulasta should only be exposed to temperatures between 5°C to 40°C (41°F and 104°F). to keep the OBI for Neulasta at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves, and other common appliances.

Failure to keep the OBI for Neulasta at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta. that if the needle is exposed after OBI for Neulasta removal, place the used OBI for Neulasta in a sharps disposal container to avoid accidental needle stick and call their healthcare provider immediately. to remove the OBI for Neulasta after the green light shines continuously and to place the used OBI for Neulasta in a sharps disposal container (see the Patient Instructions for Use) .

Advise the patient: do not reapply the OBI for Neulasta if the OBI for Neulasta comes off before full dose is delivered and instead call their healthcare provider immediately, as they may need a replacement do… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The pharmacokinetics of pegfilgrastim was studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim was nonlinear, and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils.

In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed.

The half-life of Neulasta ranged from 15 to 80 hours after subcutaneous injection. In healthy volunteers, the pharmacokinetics of pegfilgrastim were comparable when delivered subcutaneously via a manual prefilled syringe versus via the on-body injector (OBI) for Neulasta. Specific Populations No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥ 65 years of age) compared with younger patients (< 65 years of age) [see Use in Specific Populations (8.5) ] .

Renal Impairment In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. Pediatric Patients with Cancer Receiving Myelosuppressive Chemotherapy The pharmacokinetics and safety of pegfilgrastim were studied in 37 pediatric patients with sarcoma in Study 4 [see Clinical Studies (14.1) ] . The mean (± standard deviation [SD]) systemic exposure (AUC 0-inf ) of Neulasta after subcutaneous administration at 100 mcg/kg was 47.9 (± 22.5) mcg ∙ hr/mL in the youngest age group (0 to 5 years, n = 11), 22.0 (± 13.1) mcg ∙ hr/mL in the 6 to 11 years age group (n = 10), and 29.3 (± 23.2) mcg ∙ hr/mL in the 12 to 21 years age group (n = 13).

The terminal elimination half-lives of the corresponding age groups were 30.1 (± 38.2) hours, 20.2 (± 11.3) hours, and 21.2 (± 16.0) hours, respectively. Patients Acutely Exposed to Myelosuppressive Doses of Radiation The pharmacokinetics of pegfilgrastim is not available in patients acutely exposed to myelosuppressive doses of radiation. Based on limited pharmacokinetic data in irradiated non-human primates, the area under the concentration-time curve (AUC), reflecting the exposure to pegfilgrastim in non-human primates following a 300 mcg/kg dose of Neulasta, appears to be greater than in humans receiving a 6 mg dose.

Results from population modeling and simulation indicate that two 6 mg doses of Neulasta administered one week apart in adults result in clinically relevant effects on duration of grade 3 and 4 neutropenia. In addition, weight-based dosing in pediatric patients weighing less than 45 kg [see Dosage and Administration (2.1 , Table 1 and 2.2) ] provides exposures comparable to those in adults receiving two 6 mg doses one week apart.

🧬 Pharmacodynamics 42 words ▾

12.2Pharmacodynamics Animal data and clinical data in humans suggest a correlation between pegfilgrastim exposure and the duration of severe neutropenia as a predictor of efficacy. Selection of the dosing regimen of Neulasta is based on reducing the duration of severe neutropenia.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Patients with Cancer Receiving Myelosuppressive Chemotherapy Neulasta was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active-controlled studies that employed doxorubicin 60 mg/m 2 and docetaxel 75 mg/m 2 administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of Neulasta.

Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC < 0.5 × 10 9 /L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of Neulasta was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia.

In Study 1, 157 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of Neulasta (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia of Neulasta-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy.

The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the Neulasta arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI - 0.2, 0.6)] and in Study 2 were 1.7 days in the Neulasta arm compared to 1.6 days in the filgrastim arm [difference in means 0.1 (95% CI - 0.2, 0.4)]. A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1. Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m 2 administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer.

In this study, 928 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥ 38.2°C and ANC ≤ 0.5 × 10 9 /L) was lower for Neulasta-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the Neulasta-treated patients compared to the placebo-treated patients.

Study 4 was a multicenter, randomized, open-label study to evaluate the efficacy, safety, and pharmacokinetics [see Clinical Pharmacology (12.3) ] of Neulasta in pediatric and young adult patients with sarcoma. Patients with sarcoma receiving chemotherapy age 0 to 21 years were eligible. Patients were randomized to receive subcutaneous Neulasta as a single-dose of 100 mcg/kg (n = 37) or subcutaneous filgrastim at a dose 5 mcg/kg/day (n = 6) following myelosuppressive chemotherapy.

Recovery of neutrophil counts was similar in the Neulasta and filgrastim groups. The most common adverse reaction reported was bone pain.

14.2Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Efficacy studies of Neulasta could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Approval of this indication was based on efficacy studies conducted in animals… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 52 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim. Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 49 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim. Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).

📄 Patient Package Insert ~3 min read ▾

Patient Information Neulasta ® (nu-las-tah) (pegfilgrastim) injection Single-Dose Prefilled Syringe and Single-Dose Vial This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 08/2026 What is Neulasta?

Neulasta is a prescription medicine that is used: in adults and children to reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count. to increase survival in adults and children with sudden exposure to high levels of radiation that damage the bone marrow so it cannot make enough blood cells (this is called hematopoietic syndrome of acute radiation syndrome [H-ARS]).

The effectiveness of Neulasta for this use was only studied in animals, because it could not be studied in people. Do not take Neulasta if you have had a serious allergic reaction to pegfilgrastim or filgrastim. Before you receive Neulasta, tell your healthcare provider about all of your medical conditions, including if you: have a sickle cell disorder. have kidney problems. are allergic to latex.

The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give Neulasta using the prefilled syringe if you have latex allergies. are pregnant or plan to become pregnant. It is not known if Neulasta will harm your unborn baby. are breastfeeding or plan to breastfeed.

It is not known if Neulasta passes into your breast milk. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive Neulasta?

Neulasta is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed "Instructions for Use" that comes with your Neulasta for information on how to prepare and inject a dose of Neulasta using the prefilled syringe. For adults of any weight and children weighing 99 pounds (45 kg) or more: You and your caregiver will be shown how to prepare and inject Neulasta using the prefilled syringe before you use it.

For children weighing less than 99 pounds (45 kg): Do not inject a dose from a Neulasta prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Neulasta prefilled syringes. Your healthcare provider will prepare and give the dose of Neulasta using the vials.

If you are receiving Neulasta because you are also receiving chemotherapy, the last dose of Neulasta should be injected at least 14 days before and 24 hours after your dose of chemotherapy. If you miss a dose of Neulasta, talk to your healthcare provider about when you should give your next dose. If you inject too much Neulasta, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are possible side effects of Neulasta? Neulasta can cause serious side effects, including: Spleen rupture. Your spleen may become enlarged and can rupture.

A ruptured spleen can cause death. Tell your healthcare provider right away if you develop pain in the left upper stomach area or your left shoulder. A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).

Tell your healthcare provider or get emergency help right away if you develop shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing. Serious allergic reactions. Allergic reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating.

If you develop any of these symptoms, stop using Neulasta and tell your healthcare provider or get emergency medical help right away. Sickle cell crises in people with sickle cell disorder. You may… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Neulasta ® (pegfilgrastim) Onpro ® kit Healthcare Provider INSTRUCTIONS FOR USE Guide to Parts Neulasta Prefilled Syringe On-body Injector for Neulasta Important READ THE FOLLOWING INSTRUCTIONS BEFORE USING NEULASTA ONPRO KIT Prescribing Information See Prescribing Information for information on Neulasta. The on-body injector is for adult patients only. The on-body injector is not recommended for patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome.

Neulasta prefilled syringe gray needle cap contains dry natural rubber, which is derived from latex. For patients who have had severe skin reactions to acrylic adhesives, consider the benefit:risk profile before administering pegfilgrastim via the on-body injector for Neulasta. Application Information The on-body injector should be applied to intact, non-irritated skin on the abdomen or back of the arm.

The back of the arm may only be used if there is a caregiver available to monitor the status of the on-body injector. The on-body injector has a self-adhesive backing to attach it to the skin, do not use additional materials to hold it in place as this could dislodge the cannula and lead to a missed or incomplete dose of Neulasta. Environmental Information Do not expose the on-body injector for Neulasta to the following environments as the on-body injector may be damaged and the patient could be injured: Diagnostic imaging (e.g., CT Scan, MRI, Ultrasound, X-ray) Radiation treatment Oxygen rich environments such as hyperbaric chambers Cautions Do not use Neulasta Onpro kit to deliver any other drug product Do not use the on-body injector if its packaging has been previously opened, or the expiration date on the carton or any components has passed.

Do not use if the name Neulasta does not appear on Neulasta Onpro kit carton. Do not modify the on-body injector. Do not attempt to reapply the on-body injector.

Do not use if either the on-body injector or prefilled syringe is dropped. Start again with a new kit Storage Information Store the kit in the refrigerator at 36 ° F to 46 ° F (2 ° C to 8 ° C) until ready for use. If the kit is stored at room temperature (68°F to 77°F [20°C to 25°C] ), for more than 12 hours, do not use.

Start again with a new kit. Keep the prefilled syringe in the kit carton until use to protect from light. Do not freeze the kit.

Do not separate the components of Neulasta Onpro kit until ready for use. For all questions, or if a patient calls you regarding any injector problems, call Amgen at 1-800-772-6436. Step 1: Prepare A Place the syringe tray and the on-body injector tray on a clean, well-lit work surface.

Allow the syringe and on-body injector to come naturally to room temperature for 30 minutes prior to activating. Do not warm the kit components using a heat source. B Choose the patient's injection site.

Ask the patient about their ability to monitor and remove the on-body injector. Use the left or right side of the abdomen, except for a two-inch area right around navel. Use the back of upper arm only if there is a caregiver available to monitor the status of the on-body injector.

Apply the on-body injector to intact, non-irritated skin. Do not apply the on-body injector on surgical sites or areas with scar tissue, moles, or excessive hair. In case of excessive hair, carefully trim hair to get the on-body injector close to the skin.

Do not apply the on-body injector on areas where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the on-body injector. Do not apply the on-body injector on areas where the on-body injector will be affected by folds in the skin. C Clean an area on the injection site larger than the on-body injector adhesive backing.

Thoroughly clean the site with alcohol to enhance on-body adherence to the skin. Only use alcohol to clean the skin. Make sure the skin is oil-free prior to applying the on-body injector.

Allow the skin to completely dry before attaching the on-body injector . Do not touch th… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 19 words ▾

Dosage and Administration ( 2 ) 08/2025 Warnings and Precautions, Large and Medium Vessel Arteritis ( 5.13 ) 08/2026

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - Kit Carton 1 - Single Dose Neulasta Prefilled Syringe 1 - Sterile On-body Injector for Neulasta NDC 55513-192-01 AMGEN Neulasta ® (pegfilgrastim) injection Onpro ® kit Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. Coli 6 mg/ 0.6 mL* 6 mg/0.6 mL* * Prefilled syringe contains 0.64 mL to deliver 6 mg/0.6 mL when used with on-body injector For Subcutaneous Use Only Carton Contents (intended to be dispensed as a unit): 1 sterile On-body Injector for Neulasta 1 Neulasta prefilled syringe labeled for use with on-body injector only 1 patient instructions for use 1 healthcare provider instructions for use, 1 Prescribing Information This Product Contains Dry Natural Rubber Store kit refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

Do Not Freeze or Shake. See full Prescribing Information and Instructions for Use Rx Only LearnOnpro.com PRINCIPAL DISPLAY PANEL - Kit Carton

PRINCIPAL DISPLAY PANEL - 0.6 mL Single Dose Prefilled Syringe NDC 55513-190-01 1 – 0.6 mL Single Dose Prefilled Syringe AMGEN Neulasta ® (pegfilgrastim) injection Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E Coli 6 mg/ 0.6 mL 6 mg/0.6 mL Single Dose Prefilled Syringe For Subcutaneous Use Only This Product Contains Dry Natural Rubber Sterile Solution - No Preservative Rx Only Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799 U.S.A. U.S.

License No. 1080 PRINCIPAL DISPLAY PANEL - 0.6 mL Single Dose Prefilled Syringe

PRINCIPAL DISPLAY PANEL - 0.4 mL Vial Carton One 0.4 mL Single-Dose Vial. Discard Unused Portion AMGEN NDC 55513-099-01 Neulasta ® (pegfilgrastim) injection 4 mg/0.4 mL 4 mg/ 0.4 mL For Subcutaneous Use Only Must be administered by a healthcare provider Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. Coli Rx Only PRINCIPAL DISPLAY PANEL - 0.4 mL Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
4.4K
Units reimbursed last 4 qtrs
2.6K
Gross reimbursed last 4 qtrs
$12.77M
Avg / prescription
$2,905.18
Avg / unit
$4,836.74
Latest quarter Q1 2026
656Rx
Fee-for-service vs managed care ⓘ
41% FFS 59% MCO
Fee-for-service · 1,810 Rx Managed care · 2,587 Rx
State Medicaid map
Alaska: no data reported AK Maine: 27 units · 1.9 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: 20 units · 1.8 per 100k residents MT North Dakota: 7 units · 0.9 per 100k residents ND Minnesota: 85 units · 1.5 per 100k residents MN Wisconsin: no data reported WI Michigan: 123 units · 1.2 per 100k residents MI New York: 308 units · 1.6 per 100k residents NY Vermont: 37 units · 5.7 per 100k residents VT New Hampshire: 26 units · 1.9 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 103 units · 0.8 per 100k residents IL Indiana: 94 units · 1.4 per 100k residents IN Ohio: 59 units · 0.5 per 100k residents OH Pennsylvania: 30 units · 0.2 per 100k residents PA New Jersey: 132 units · 1.4 per 100k residents NJ Massachusetts: 705 units · 10.1 per 100k residents MA California: 176 units · 0.5 per 100k residents CA Utah: 1 units · 0.0 per 100k residents UT Colorado: 7 units · 0.1 per 100k residents CO Nebraska: 5 units · 0.3 per 100k residents NE Missouri: 74 units · 1.2 per 100k residents MO Kentucky: 46 units · 1.0 per 100k residents KY West Virginia: 106 units · 6.0 per 100k residents WV Virginia: 79 units · 0.9 per 100k residents VA Maryland: 10 units · 0.2 per 100k residents MD Connecticut: 20 units · 0.6 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 11 units · 0.5 per 100k residents NM Kansas: 5 units · 0.2 per 100k residents KS Arkansas: 8 units · 0.3 per 100k residents AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 35 units · 3.4 per 100k residents DE Oklahoma: 7 units · 0.2 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 7 units · 0.1 per 100k residents GA D.C.: no data reported DC Hawaii: 20 units · 1.4 per 100k residents HI Texas: 224 units · 0.7 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.010.1
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 Massachusetts 10.1 /100k
2 West Virginia 6.0 /100k
3 Vermont 5.7 /100k
4 Delaware 3.4 /100k
5 Maine 1.9 /100k
6 New Hampshire 1.9 /100k
7 Montana 1.8 /100k
8 New York 1.6 /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.

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

Medicare Part D (outpatient prescription) spending for Neulasta — 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 Neulasta. 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
$9.22M
Claims incl. refills
1.3K
Beneficiaries
596
Spend / beneficiary
$15,462.26
Spend / claim
$7,348.89
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.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Amgen, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amgen, 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 J2506 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.
← 55513-0190-01 · Amgen, 55513-0206-01 · Amgen, →
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.