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NYVEPRIA pegfilgrastim-apgf 6 mg/.6mL Injection, Solution, 1 syringe — NDC 0069-0324-01 (Billing 00069-0324-01)

by Pfizer Laboratories Div Pfizer Inc · 1 CARTON in 1 CARTON / 1 SYRINGE in 1 CARTON / .6 mL in 1 SYRINGE

This is a package of 1 syringe of NYVEPRIA pegfilgrastim-apgf 6 mg/.6mL Injection, Solution from Pfizer Laboratories Div Pfizer Inc, marketed since Dec 2020 and currently FDA-listed. It is this product's only package size.

NDC 00069-0324-01
🏷️ FDA NDC (as labeled) 0069-0324-01 billing pads the labeler 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 Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

NDC database record

One package, one record: these facts belong to NDC 0069-0324-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0069 labeler · 0324 product · 01 package
Package marketed since
Dec 15, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0069032401 2
Medicaid fills, this package
4,621 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0069-0324-01
Product NDC 0069-0324
11-digit billing NDC 00069032401
NCPDP billing unit ML — per mL (volume)
RxCUI 2469335, 2469340
UNII 3A58010674
Application # BLA761111
SPL Set ID 99d30b99-2743-446b-98f3-0430bf4ea869
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 2020-12-15
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance PEGFILGRASTIM
Biologic (Purple Book) 351(k) Biosimilar · biosimilar
Reference product pegfilgrastim

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

GPI-14 8240157002E520
GPI class Nyvepria
GCN Seq No 081179
GCN 48222
HICL code 046612
Ingredient (HICL) Pegfilgrastim-Apgf
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 NYVEPRIA 6 MG/0.6 ML SYRINGE
FDB brand name Nyvepria
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 081179
  • GCN: 48222
  • GPI-14 (Medi-Span): 8240157002E520
  • HICL (First Databank): 046612
  • AHFS class code: 20:16.00.00
  • RxCUI (RxNorm): 2469335
Why two NDCs? The FDA registers this code as 0069-0324-01 — a 4-4-2 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 labeler segment → 00069-0324-01. 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 NYVEPRIA 6 MG/0.6 ML SYRINGE Ingredient Pegfilgrastim-Apgf
📖 What it is MedlinePlus · NLM

Pegfilgrastim injection is used to increase white blood cells and decrease the risk of infection in patients receiving chemotherapy for certain types of cancer. Pegfilgrastim injection is 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 (a type of blood cell needed to fight infection).

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $5,285.06 $3,171.04 / 0.6 ml
Medicare drug plans payPart D · Q2 2026 $6,227.53 $3,736.52 / 0.6 ml
Medicare Part B allowsASP · Q5122 $136.911 / Q5122 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)0069-0324-01
11-digit billing NDC00069-0324-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeQ5122
DescriptorInjection, pegfilgrastim-apgf (nyvepria), biosimilar, 0.5 mg
Billing units / pkg12 units
How the units are derivedThis package is 0.6; the HCPCS unit is 0.5 MG, so one package = 12 billing units.
Medicare Part B spend (2026 (Q1))$3,098,777 · 2,011 claims · $1,540.91 per claim (all NDCs under Q5122)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
00069-0324-01 You're viewing this Main listing 1 CARTON in 1 CARTON / 1 SYRINGE in 1 CARTON / .6 mL in 1 SYRINGE 2020-12-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nyvepria 6 mg/.6mLthis 00069-0324-01 Pfizer 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

🏛️
2020
First FDA approval
Jun 2020
📍
2026
Currently FDA-listed
6 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 2032.
📅 FDA approved Jun 10, 2020

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
Exclusivity RefProduct
2020 2022 2024 2026 2028 2030 2032
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.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJun 10, 2032
Common questions
Is there a biosimilar for NYVEPRIA 6 MG/0.6 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerPfizer Laboratories Div Pfizer Inc
FDA applicationBLA761111 (BLA)
Labeler code00069
First marketedDec 2020
Product typeHuman Prescription Drug
Portfolio242 products on file

More NDCs from Pfizer Laboratories Div Pfizer Inc labeler code 00069

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 153 words ▾

1 INDICATIONS AND USAGE Patients with Cancer Receiving Myelosuppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older 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 Dosage and Administration (2.1) and Clinical Studies (14) ] . NYVEPRIA is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older 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 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

⏱️ Dosage and Administration ~1 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 ) • Do not administer between 14 days before and 24 hours after administration of chemotherapy. ( 2.1 )

2.1Patients with Cancer Receiving Myelosuppressive Chemotherapy The recommended dosage of NYVEPRIA 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. Do not administer NYVEPRIA between 14 days before and 24 hours after administration of chemotherapy.

2.2Preparation and Administration NYVEPRIA is supplied in a single-dose prefilled syringe for manual use [see Dosage Forms and Strengths (3) ] . Before using NYVEPRIA: • Remove the carton from the refrigerator and allow the NYVEPRIA prefilled syringe 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 left at room temperature for greater than 15 days. • NYVEPRIA 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 NYVEPRIA if discoloration or particulates are observed.

Prefilled Syringe for Manual Use For adult patients of any weight and pediatric patients weighing at least 45 kg, the single-dose prefilled syringe for manual use is intended for subcutaneous administration of a single 6 mg/0.6 mL dose of NYVEPRIA. The syringe does not bear graduation marks and therefore does not allow for direct administration of doses less than 6 mg/0.6 mL. There is no presentation for NYVEPRIA that allows weight-based dosing for pediatric patients below 45 kg.

The NYVEPRIA syringe plunger stopper and needle cover are not made with natural rubber latex.

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS NYVEPRIA 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 solution in a single-dose prefilled syringe for manual use only. ( 3 )

⛔ Contraindications 50 words ▾

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

⚠️ Warnings and Cautions ~2 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 NYVEPRIA in patients with ARDS.

( 5.2 ) • Serious hypersensitivity reactions, including anaphylaxis: Permanently discontinue NYVEPRIA in patients with serious hypersensitivity reactions. ( 5.3 ) • Fatal sickle cell crises: Discontinue NYVEPRIA if sickle cell crisis occurs. ( 5.4 ) • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of NYVEPRIA if causality is likely.

( 5.5 ) • Thrombocytopenia: Monitor platelet counts. ( 5.7 ) • Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using NYVEPRIA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. ( 5.10 ) • Aortitis: Discontinue NYVEPRIA if aortitis is suspected.

( 5.11 )

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

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

5.3Serious Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. 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 NYVEPRIA in patients with serious hypersensitivity reactions. NYVEPRIA is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products.

5.4Use in Patients with Sickle Cell Disorders Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue NYVEPRIA if sickle cell crisis occurs.

5.5Glomerulonephritis Glomerulonephritis has occurred in patients receiving pegfilgrastim products. 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 pegfilgrastim products.

If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of NYVEPRIA.

5.6Leukocytosis White blood cell (WBC) counts of 100 × 10 9 /L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during NYVEPRIA therapy is recommended.

5.7Thrombocytopenia Pegfilgrastim products can cause thrombocytopenia. Monitor platelet counts during NYVEPRIA therapy.

5.8Capillary Leak Syndrome Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, 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 syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

5.9Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte-colony stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as… [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) ] • Use in Patients with Sickle Cell Disorders [see Warnings and Precautions (5.4) ] • Glomerulonephritis [see Warnings and Precautions (5.5) ] • Leukocytosis [see Warnings and Precautions (5.6) ] • Thrombocytopenia [see Warnings and Precautions (5.7) ] • Capillary Leak Syndrome [see Warnings and Precautions (5.8) ] • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.9) ] • Myelodysplastic Syndrome [see Warnings and Precautions (5.10) ] • Acute Myeloid Leukemia [see Warnings and Precautions (5.10) ] • Aortitis [see Warnings and Precautions (5.11) ] 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 Pfizer Inc. at 1-800-438-1985 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. Pegfilgrastim clinical trials safety data are based upon 932 patients receiving pegfilgrastim 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 pegfilgrastim 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 1 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 pegfilgrastim (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 1.

Adverse Reactions with ≥5% Higher Incidence in Pegfilgrastim Patients Compared to Placebo in Study 3 Body System Adverse Reaction Placebo (N = 461) Pegfilgrastim 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 pegfilgrastim. No complications attributable to leukocytosis were reported in clinical studies.

6.3Postmarketing Experience The following adverse reactions have been identified during post-approval use of pegfilgrastim products. 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 cell crisis [see Warnings an… [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 pegfilgrastim product 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 to 4% and 15 to 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 products 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 NYVEPRIA and any potential adverse effects on the breastfed child from NYVEPRIA or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of NYVEPRIA for chemotherapy-induced neutropenia have been established in pediatric patients aged newborn and older. Use of NYVEPRIA in pediatric patients weighing at least 45 kg for chemotherapy-induced neutropenia is supported by evidence from adequate and well-controlled studies of pegfilgrastim in adults with additional pharmacokinetic and safety data of pegfilgrastim in pediatric patients aged 8 months and older with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] .

8.5Geriatric Use Of the 932 patients with cancer who received pegfilgrastim in clin… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Although available data with pegfilgrastim product 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 to 4% and 15 to 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 77 words ▾

8.4Pediatric Use The safety and effectiveness of NYVEPRIA for chemotherapy-induced neutropenia have been established in pediatric patients aged newborn and older. Use of NYVEPRIA in pediatric patients weighing at least 45 kg for chemotherapy-induced neutropenia is supported by evidence from adequate and well-controlled studies of pegfilgrastim in adults with additional pharmacokinetic and safety data of pegfilgrastim in pediatric patients aged 8 months and older with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] .

🧓 Geriatric Use 48 words ▾

8.5Geriatric Use Of the 932 patients with cancer who received pegfilgrastim 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 71 words ▾

10 OVERDOSAGE Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim 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 ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pegfilgrastim products are colony-stimulating factors that act 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 products' exposure and the duration of severe neutropenia as a predictor of efficacy. Selection of the dosing regimen of NYVEPRIA 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 pegfilgrastim ranged from 15 to 80 hours after subcutaneous injection. 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) ] . The mean (± standard deviation [SD]) systemic exposure (AUC 0–inf ) of pegfilgrastim 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.

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. Binding antibodies to pegfilgrastim were detected using a BIAcore assay.

The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment.

None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.

🧬 Mechanism of Action 31 words ▾

12.1Mechanism of Action Pegfilgrastim products are colony-stimulating factors that act 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 178 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING NYVEPRIA (pegfilgrastim-apgf) injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-apgf, supplied with a 27-gauge 1/2-inch needle and a BD UltraSafe Plus™ Passive Needle Guard. The NYVEPRIA syringe plunger stopper and needle cover are not made with natural rubber latex. NYVEPRIA is provided in a dispensing carton containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 0069-0324-01).

NYVEPRIA 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. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe. Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

Discard syringes stored at room temperature for more than 15 days. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

Do not shake.

📦 Storage and Handling 48 words ▾

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Discard syringes stored at room temperature for more than 15 days. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once. Do not shake.

📋 Description 178 words ▾

11 DESCRIPTION Pegfilgrastim-apgf is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF 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-apgf, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-apgf is approximately 39 kD. NYVEPRIA 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). The delivered 0.6 mL dose from the prefilled syringe for manual subcutaneous injection contains 6 mg pegfilgrastim-apgf (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.01 mg), and sorbitol (30 mg) in Water for Injection, USP.

💬 Information for Patients 137 words ▾

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 NYVEPRIA: • 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 NYVEPRIA in conjunction with chemotherapy and/or radiation therapy • Capillary Leak Syndrome • Aortitis Instruct patients who self-administer NYVEPRIA using the single-dose 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.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com .

🧬 Pharmacokinetics ~1 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 pegfilgrastim ranged from 15 to 80 hours after subcutaneous injection. 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) ] . The mean (± standard deviation [SD]) systemic exposure (AUC 0–inf ) of pegfilgrastim 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.

🧬 Pharmacodynamics 43 words ▾

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

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Patients with Cancer Receiving Myelosuppressive Chemotherapy Pegfilgrastim 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 pegfilgrastim.

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 pegfilgrastim 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 pegfilgrastim (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 pegfilgrastim (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 pegfilgrastim-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 pegfilgrastim 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 pegfilgrastim 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 pegfilgrastim (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 pegfilgrastim-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 pegfilgrastim-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 pegfilgrastim 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 pegfilgrastim 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 pegfilgrastim and filgrastim groups. The most common adverse reaction reported was bone pain.

🧪 Nonclinical Toxicology 53 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim products. 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 50 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim products. 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 ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: May 2026 Patient Information NYVEPRIA™ (nigh-VEP ree-ah) (pegfilgrastim-apgf) injection Single-Dose Prefilled Syringe What is NYVEPRIA?

NYVEPRIA is a prescription medicine that is used in adults and children aged newborn and older to help 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. Do not take NYVEPRIA if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products. Before you receive NYVEPRIA, tell your healthcare provider about all of your medical conditions, including if you: • have a sickle cell disorder. • have kidney problems. • are pregnant or plan to become pregnant.

It is not known if NYVEPRIA will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if NYVEPRIA 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 NYVEPRIA? • NYVEPRIA 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 NYVEPRIA for information on how to prepare and inject a dose of NYVEPRIA using the single-dose prefilled syringe. • You and your caregiver will be shown how to prepare and inject NYVEPRIA using the single-dose prefilled syringe before you use it. • You should not inject a dose of NYVEPRIA to children weighing less than 99 pounds (45 kg) from a NYVEPRIA prefilled syringe.

A dose less than 0.6 mL (6 mg) cannot be accurately measured using the NYVEPRIA prefilled syringe. • If you are receiving NYVEPRIA because you are also receiving chemotherapy, the last dose of NYVEPRIA should be injected at least 14 days before and 24 hours after your dose of chemotherapy. • If you miss a dose of NYVEPRIA, talk to your healthcare provider about when you should give your next dose. • If you inject too much NYVEPRIA, 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 NYVEPRIA? NYVEPRIA may cause serious side effects, including: • Spleen rupture. Your spleen may become enlarged and can rupture.

A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder. • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency help right away if you have 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 have any of these symptoms, stop using NYVEPRIA and call your healthcare provider or get emergency medical help right away. • Sickle cell crises in people with sickle cell disorder. You may have a severe sickle cell crisis, which could lead to death.

Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing. • Kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: o swelling of your face or ankles o blood in your urine or dark colored urine o you urinate less than usual • Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood count during treatment with NYVEPRIA. • Decreased platelet count (thrombocytopenia).

Your healthcare provider will check… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use NYVEPRIA (nigh-VEP ree-ah) (pegfilgrastim-apgf) injection, for subcutaneous use Single-Dose Prefilled Syringe Guide to parts Before use After use Important: The needle is covered by the needle cover before use. Important Read the Patient Information for important information that you need to know about NYVEPRIA before using these Instructions for Use. Before you use a NYVEPRIA prefilled syringe, read this important information.

Storing the prefilled syringe • Store NYVEPRIA in the refrigerator between 36°F to 46°F (2°C to 8°C). • Do not freeze. If NYVEPRIA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting. • Do not use a NYVEPRIA prefilled syringe that has been frozen more than 1 time. Throw it away and use a new NYVEPRIA prefilled syringe. • Keep the prefilled syringe in the original carton to protect from light or physical damage. • Take the prefilled syringe out of the refrigerator 30 minutes before use and allow it to reach room temperature, 68°F to 77°F (20°C to 25°C), before preparing an injection. • Throw away (dispose of) any NYVEPRIA that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 15 days. • Keep NYVEPRIA and all medicines out of the reach of children.

Using the prefilled syringe • It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider. • Make sure the name NYVEPRIA appears on the carton and prefilled syringe label. • Check the carton and prefilled syringe label to make sure the dose strength is 6 mg. • You should not inject a dose of NYVEPRIA to children weighing less than 99 pounds (45 kg) from a NYVEPRIA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the NYVEPRIA prefilled syringe. • Do not use a prefilled syringe after the expiration date on the label. • Do not shake the prefilled syringe. • Do not remove the needle cover from the prefilled syringe until you are ready to inject. • Do not use the prefilled syringe if the carton is open or damaged. • Do not use a prefilled syringe if it has been dropped on a hard surface.

The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe. • The prefilled syringe has a needle guard that automatically activates to cover the needle after the injection is given. Do not use a prefilled syringe if the needle guard has been activated.

Use another prefilled syringe that has not been activated and is ready to use. Call your healthcare provider if you have any questions. Step 1: Prepare A.

Remove the prefilled syringe carton from the refrigerator. Check the expiration date. Important: Do not use if the expiration date has passed.

Remove the inner carton containing the prefilled syringe from the outer carton by peeling away the cover. On a clean, well-lit surface, place the inner carton containing the prefilled syringe at room temperature, 68°F to 77°F (20°C to 25°C), for 30 minutes before you give an injection. • Do not use the prefilled syringe if the inner carton is damaged. • Do not try to warm the prefilled syringe by using a heat source such as hot water or microwave. • Do not leave the prefilled syringe in direct sunlight. • Do not shake the prefilled syringe.

Open the inner carton containing the prefilled syringe by peeling away the cover. Grab the needle guard to remove the prefilled syringe from the inner carton containing the prefilled syringe. For safety reasons: • Do not grab the plunger rod. • Do not grab the needle cover.

B . Inspect the medicine and prefilled syringe. Make sure the medicine in the prefilled syringe is clear and colorless.

It is normal to see air bubbles in the syringe. • Do not use the prefilled syringe if: o The medicine is cloudy or discolored or contains flakes or particles. o Any part appears cracked or broken. o The prefilled syringe has been dropped. o The needle cover is missing or not… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 187 words ▾

PRINCIPAL DISPLAY PANEL - 6 mg/0.6 mL Syringe Label Nyvepria™ (pegfilgrastim-apgf) Injection Rx only 6 mg/0.6 mL For Subcutaneous Use Only Single-Dose Prefilled Syringe with Needle Guard NDC 0069-0324-01 Mfd by Hospira, Inc., a Pfizer Company Lake Forest, IL 60045 USA US License No. 1974 PAA147907 PRINCIPAL DISPLAY PANEL - 6 mg/0.6 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 6 mg/0.6 mL Syringe Inner Carton – PAA207017 Nyvepria™ (pegfilgrastim-apgf) Injection 6 mg/0.6 mL For Subcutaneous Use Only Sterile Solution - No Preservative 1 x 6 mg/0.6 mL Single-Dose Prefilled Syringe with Needle Guard Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E coli NDC 0069-0324-01 Rx Only PRINCIPAL DISPLAY PANEL - 6 mg/0.6 mL Syringe Inner Carton – PAA207017

PRINCIPAL DISPLAY PANEL - 6 mg/0.6 mL Syringe Outer Carton – PAA207018 Nyvepria™ (pegfilgrastim-apgf) Injection 6 mg/0.6 mL For Subcutaneous Use Only Sterile Solution - No Preservative 1 x 6 mg/0.6 mL Single-Dose Prefilled Syringe with Needle Guard Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E coli NDC 0069-0324-01 Rx Only PRINCIPAL DISPLAY PANEL - 6 mg/0.6 mL Syringe Outer Carton – PAA207018

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
4.6K
Units reimbursed last 4 qtrs
2.9K
Gross reimbursed last 4 qtrs
$15.21M
Avg / prescription
$3,290.44
Avg / unit
$5,285.43
Latest quarter Q1 2026
753Rx
Fee-for-service vs managed care ⓘ
25% FFS 75% MCO
Fee-for-service · 1,145 Rx Managed care · 3,476 Rx
State Medicaid map
Alaska: no data reported AK Maine: 24 units · 1.7 per 100k residents ME Washington: 9 units · 0.1 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 69 units · 1.2 per 100k residents MN Wisconsin: 58 units · 1.0 per 100k residents WI Michigan: 420 units · 4.2 per 100k residents MI New York: 380 units · 1.9 per 100k residents NY Vermont: no data reported VT New Hampshire: 54 units · 3.9 per 100k residents NH Oregon: 8 units · 0.2 per 100k residents OR Nevada: 28 units · 0.9 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 10 units · 0.3 per 100k residents IA Illinois: 38 units · 0.3 per 100k residents IL Indiana: no data reported IN Ohio: 72 units · 0.6 per 100k residents OH Pennsylvania: 24 units · 0.2 per 100k residents PA New Jersey: 24 units · 0.3 per 100k residents NJ Massachusetts: no data reported MA California: 58 units · 0.1 per 100k residents CA Utah: 32 units · 0.9 per 100k residents UT Colorado: 7 units · 0.1 per 100k residents CO Nebraska: 20 units · 1.0 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 37 units · 0.4 per 100k residents VA Maryland: 11 units · 0.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 15 units · 0.2 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 43 units · 0.8 per 100k residents SC Delaware: 52 units · 5.0 per 100k residents DE Oklahoma: no data reported OK Louisiana: 26 units · 0.6 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 137 units · 1.2 per 100k residents GA D.C.: no data reported DC Hawaii: 55 units · 3.8 per 100k residents HI Texas: 339 units · 1.1 per 100k residents TX Florida: 826 units · 3.7 per 100k residents FL
Units reimbursed · per 100k residents
0.15.0
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 Delaware 5.0 /100k
2 Michigan 4.2 /100k
3 New Hampshire 3.9 /100k
4 Hawaii 3.8 /100k
5 Florida 3.7 /100k
6 New York 1.9 /100k
7 Maine 1.7 /100k
8 Georgia 1.2 /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 Nyvepria — 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 Nyvepria. 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
$6.64M
Claims incl. refills
1.6K
Beneficiaries
762
Spend / beneficiary
$8,711.78
Spend / claim
$4,080.13
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 NYVEPRIA (this brand).

Top reported reactions

Death23
Pyrexia15
Drug Dose Omission By Device12
Device Leakage11
Nausea11
Fatigue10
Asthenia9

Age at onset

Adult9
Elderly6

Reporter sex

193 reports

Serious outcomes

Hospitalization65
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 67 0
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.

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 — Not published for this NDC No photo available yet for this listing.
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 Pfizer Laboratories Div Pfizer Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pfizer Laboratories Div Pfizer 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 Q5122 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.
← 00069-0315-01 · Pfizer 00069-0334-28 · Pfizer →
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.