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Nivestym filgrastim-aafi 300 ug/.5mL Injection, Solution, 1 syringe — NDC 00069-0291-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nivestym filgrastim-aafi 300 ug/.5mL Injection, Solution, 1 syringe — NDC 0069-0291-01 (Billing 00069-0291-01)

by Pfizer Laboratories Div Pfizer Inc · 1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE

This is a package of 1 syringe of Nivestym filgrastim-aafi 300 ug/.5mL Injection, Solution from Pfizer Laboratories Div Pfizer Inc, marketed since Sep 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00069-0291-01
🏷️ FDA NDC (as labeled) 0069-0291-01 billing pads the labeler segment with a zero
This package
Contains1 syringe Medicaid pays$355.35 / unit · 12 mo Per package$177.67 / 0.5 ml · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $416.80/unit — full pricing hub ↓
Main listing for product 0069-0291 · Also comes in: 1 syringe 0069-0291-10
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 →

This page is curated, coded, and maintained by

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 0069-0291-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0069 labeler · 0291 product · 01 package
Package marketed since
Sep 24, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0069029101 7
Medicaid fills, this package
2,050 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) 0069-0291-01
Product NDC 0069-0291
11-digit billing NDC 00069029101
NCPDP billing unit ML — per mL (volume)
RxCUI 2057200, 2057205, 2057209, 2057212, 2057215, 2057216, 2057218, 2057219
UNII PVI5M0M1GW
Application # BLA761080
SPL Set ID d23ab39c-b6ec-41cf-a529-9dd2852c9d9a
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 2018-09-24
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance FILGRASTIM
Biologic (Purple Book) 351(k) Biosimilar · biosimilar
Reference product filgrastim

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

GPI-14 8240152010E520
GPI class Nivestym
GCN Seq No 078721
GCN 45103
HICL code 045154
Ingredient (HICL) Filgrastim-Aafi
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 NIVESTYM 300 MCG/0.5 ML SYRING
FDB brand name Nivestym
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078721
  • GCN: 45103
  • GPI-14 (Medi-Span): 8240152010E520
  • HICL (First Databank): 045154
  • AHFS class code: 20:16.00.00
  • RxCUI (RxNorm): 2057200
Why two NDCs? The FDA registers this code as 0069-0291-01 — 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 → 00069-0291-01. 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 NIVESTYM 300 MCG/0.5 ML SYRING Ingredient Filgrastim-Aafi
📖 What it is MedlinePlus · NLM

Filgrastim injection is used to increase white blood cells and decrease the risk of infection in patients receiving chemotherapy for certain types of cancer to increase white blood cells in people who are undergoing bone marrow transplants and in people who have severe chronic neutropenia (condition in which there are a low number of neutrophils in the blood). to prepare the blood for leukapheresis (a treatment in which certain blood cells are removed from the body). to increase the chance of survival in people who have been exposed to harmful amounts of radiation, which can cause sever...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It raises your neutrophils, the white blood cells that fight infection. It is used for people on chemotherapy, those with AML, bone marrow transplant patients, stem cell collection...
  • It is injected under the skin or given into a vein, depending on your condition. Some people or caregivers are trained to give injections at home. If you miss a dose, call your hea...
  • Common ones include bone pain, fever, rash, cough, headache and nosebleeds. Tell your care team about any that bother you.
  • Call for left upper belly or shoulder pain, trouble breathing, signs of allergic reaction, blood in your urine, swelling, or unexplained fever with belly or back pain. These can be...
📖 Read our full Filgrastim 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 $355.35 $177.67 / 0.5 ml
Medicare drug plans payPart D · Q2 2026 $416.80 $208.40 / 0.5 ml
Medicare Part B allowsASP · Q5110 $0.322 / Q5110 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)0069-0291-01
11-digit billing NDC00069-0291-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeQ5110
DescriptorINJECTION, FILGRASTIM-AAFI, BIOSIMILAR, (NIVESTYM), 1 MICROGRAM
Billing units / pkg600 units
How the units are derivedThis package is 0.5 ML; the HCPCS unit is 1 MCG, so one package = 600 billing units.
Medicare Part B spend (2026 (Q1))$835,160 · 6,956 claims · $120.06 per claim (all NDCs under Q5110)
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
00069-0291-01 You're viewing this Main listing 1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE 2018-09-24 — Active
00069-0291-10 0069-0291-10 10 CARTON in 1 CARTON / 1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE 2018-09-24 — Active

In Medicaid, this is the most-dispensed pack of this product — about 72% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1 syringe — 1 syringe in 1 carton / .5 ml in 1 syringe.
What NDC number is used to bill for this package of Nivestym filgrastim-aafi 300 ug/.5mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nivestym 300 ug/.5mLthis 00069-0291-01 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

🏛️
2018
First FDA approval
Jul 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
2026
Biosimilars listed
4 FDA-licensed
🧬FDA-licensed biosimilars listed

4 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 Jul 2030.
📅 FDA approved Jul 20, 2018

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
Neupogenfilgrastim
Biosimilars 4
Nivestymfilgrastim-aafi Nypozifilgrastim-txid Releukofilgrastim-ayow Zarxiofilgrastim-sndz
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
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.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJul 20, 2030
Common questions
Is there a biosimilar for NIVESTYM 300 MCG/0.5 ML SYRING?
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.

🧪 Avoiding an ingredient? See Filgrastim Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 0.02 mg / 0.5 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • 25 mg / 0.5 mL UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerPfizer Laboratories Div Pfizer Inc
FDA applicationBLA761080 (BLA)
Labeler code00069
First marketedSep 2018
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 ~2 min read ▾

1 INDICATIONS AND USAGE NIVESTYM is a leukocyte growth factor indicated to • Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. ( 1.1 ) • Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). ( 1.2 ) • Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).

( 1.3 ) • Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. ( 1.4 ) • Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia. ( 1.5 )

1.1Patients with Cancer Receiving Myelosuppressive Chemotherapy NIVESTYM is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] .

1.2Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NIVESTYM is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] .

1.3Patients with Cancer Undergoing Bone Marrow Transplantation NIVESTYM is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ].

1.4Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NIVESTYM is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] .

1.5Patients with Severe Chronic Neutropenia NIVESTYM is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [see Clinical Studies (14.5) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML. o Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion. See Full Prescribing Information for recommended dosage adjustments and timing of administration. ( 2.1 ) • Patients with cancer undergoing bone marrow transplantation. o 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours.

See Full Prescribing Information for recommended dosage adjustments and timing of administration. ( 2.2 ) • Patients undergoing autologous peripheral blood progenitor cell collection and therapy. o 10 mcg/kg/day subcutaneous injection. ( 2.3 ) o Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis.

( 2.3 ) • Patients with congenital neutropenia. o Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily. ( 2.4 ) • Patients with cyclic or idiopathic neutropenia. o Recommended starting dose is 5 mcg/kg subcutaneous injection daily. ( 2.4 ) • Direct administration of less than 0.3 mL (180 mcg) using NIVESTYM prefilled syringe is not recommended due to potential for dosing errors.

( 2.5 )

2.1Dosage in Patients with Cancer Receiving Myelosuppressive Chemotherapy or Induction and/or Consolidation Chemotherapy for AML The recommended starting dosage of NIVESTYM is 5 mcg/kg/day‚ administered as a single daily injection by subcutaneous injection‚ by short intravenous infusion (15 to 30 minutes)‚ or by continuous intravenous infusion. Obtain a complete blood count (CBC) and platelet count before instituting NIVESTYM therapy and monitor twice weekly during therapy. Consider dose escalation in increments of 5 mcg/kg for each chemotherapy cycle‚ according to the duration and severity of the absolute neutrophil count (ANC) nadir.

Recommend stopping NIVESTYM if the ANC increases beyond 10‚000/mm 3 [see Warnings and Precautions (5.10) ] . Administer NIVESTYM at least 24 hours after cytotoxic chemotherapy. Do not administer NIVESTYM within the 24-hour period prior to chemotherapy [see Warnings and Precautions (5.13) ] .

A transient increase in neutrophil count is typically seen 1 to 2 days after initiation of NIVESTYM therapy. Therefore, to ensure a sustained therapeutic response‚ administer NIVESTYM daily for up to 2 weeks or until the ANC has reached 10‚000/mm 3 following the expected chemotherapy-induced neutrophil nadir. The duration of NIVESTYM therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed.

2.2Dosage in Patients with Cancer Undergoing Bone Marrow Transplantation The recommended dosage of NIVESTYM following bone marrow transplantation (BMT) is 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. Administer the first dose of NIVESTYM at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion. Monitor CBCs and platelet counts frequently following marrow transplantation.

During the period of neutrophil recovery‚ titrate the daily dosage of NIVESTYM against the neutrophil response (see Table 1 ). Table 1. Recommended Dosage Adjustments During Neutrophil Recovery in Patients with Cancer Following BMT Absolute Neutrophil Count NIVESTYM Dosage Adjustment When ANC greater than 1,000/mm 3 for 3 consecutive days Reduce to 5 mcg/kg/day If ANC decreases to less than 1,000/mm 3 at any time during the 5 mcg/kg/day administration‚ increase NIVESTYM to 10 mcg/kg/day‚ and then follow the above steps.

Then, if ANC remains greater than 1,000/mm 3 for 3 more consecutive days Discontinue NIVESTYM Then, if ANC decreases to less than 1,000/mm 3 Resume at 5 mcg/kg/day

2.3Dosage in Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy The recommended dosage of NIVESTYM for t… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 109 words ▾

3 DOSAGE FORMS AND STRENGTHS Vial • Injection: 300 mcg/mL in a single-dose vial ( 3 ) • Injection: 480 mcg/1.6 mL (300 mcg/mL) in a single-dose vial ( 3 ) Prefilled Syringe • Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe ( 3 ) • Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe ( 3 ) NIVESTYM is a clear, colorless solution available as: Vial: • Injection: 300 mcg/mL in a single-dose vial • Injection: 480 mcg/1.6 mL (300 mcg/mL) in a single-dose vial Prefilled Syringe: • Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe • Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe

⛔ Contraindications 56 words ▾

4 CONTRAINDICATIONS NIVESTYM is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products [see Warnings and Precautions (5.3) ] . Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim 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 and lung infiltrates or respiratory distress for ARDS. • Discontinue NIVESTYM in patients with ARDS. ( 5.2 ) • Serious allergic reactions, including anaphylaxis: Permanently discontinue NIVESTYM in patients with serious allergic reactions.

( 5.3 ) • Fatal sickle cell crises: Discontinue NIVESTYM if sickle cell crisis occurs. ( 5.4 ) • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of NIVESTYM if causality is likely. ( 5.5 ) • Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using NIVESTYM in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.

( 5.8 ) • Thrombocytopenia: Monitor platelet counts. ( 5.9 ) • Aortitis: Aortitis has been reported in patients receiving NIVESTYM. Discontinue NIVESTYM if aortitis is suspected.

( 5.15 )

5.1Splenic Rupture Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

5.2Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) has been reported in patients receiving filgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue NIVESTYM in patients with ARDS.

5.3Serious Allergic Reactions Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions.

Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue NIVESTYM in patients with serious allergic reactions. NIVESTYM is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

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

5.5Glomerulonephritis Glomerulonephritis has occurred in patients receiving filgrastim 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 filgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of NIVESTYM.

5.6Alveolar Hemorrhage and Hemoptysis Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization have been reported in healthy donors treated with filgrastim products undergoing peripheral blood progenitor cell (PBPC) collection mobilization. Hemoptysis resolved with discontinuation of filgrastim products. The use of NIVESTYM for PBPC mobilization in healthy donors is not an approved indication.

5.7Capillary Leak Syndrome Capillary leak syndrome (CLS) has been reported after G-CSF administration, including filgrastim 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.

5.8Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) Patients with Severe Chron… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious 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 Allergic Reactions [see Warnings and Precautions (5.3) ] • Sickle Cell Disorders [see Warnings and Precautions (5.4) ] • Glomerulonephritis [see Warnings and Precautions (5.5) ] • Alveolar Hemorrhage and Hemoptysis [see Warnings and Precautions (5.6) ] • Capillary Leak Syndrome [see Warnings and Precautions (5.7) ] • Myelodysplastic Syndrome [see Warnings and Precautions (5.8) ] • Acute Myeloid Leukemia [see Warnings and Precautions (5.8) ] • Thrombocytopenia [see Warnings and Precautions (5.9) ] • Leukocytosis [see Warnings and Precautions (5.10) ] • Cutaneous Vasculitis [see Warnings and Precautions (5.11) ] • Aortitis [see Warnings and Precautions (5.15) ] Most common adverse reactions in patients: • With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea.

( 6.1 ) • With AML (≥ 2% difference in incidence) are pain, epistaxis and rash. ( 6.1 ) • With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash. ( 6.1 ) • Undergoing peripheral blood progenitor cell mobilization and collection (≥ 5% incidence) are bone pain, pyrexia and headache.

( 6.1 ) • With severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia. ( 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. Adverse Reactions in Patients with Cancer Receiving Myelosuppressive Chemotherapy The following adverse reaction data in Table 2 are from three randomized, placebo-controlled studies in patients with: • small cell lung cancer receiving standard dose chemotherapy with cyclophosphamide‚ doxorubicin‚ and etoposide (Study 1) • small cell lung cancer receiving ifosfamide, doxorubicin‚ and etoposide (Study 2), and • non-Hodgkin's lymphoma (NHL) receiving doxorubicin, cyclophosphamide, vindesine, bleomycin, methylprednisolone, and methotrexate ("ACVBP") or mitoxantrone, ifosfamide, mitoguazone, teniposide, methotrexate, folinic acid, methylprednisolone, and methotrexate ("VIM3") (Study 3).

A total of 451 patients were randomized to receive subcutaneous filgrastim 230 mcg/m 2 (Study 1), 240 mcg/m 2 (Study 2) or 4 or 5 mcg/kg/day (Study 3) (n = 294) or placebo (n = 157). The patients in these studies were median age 61 (range 29 to 78) years and 64% were male. The ethnicity was 95% Caucasian, 4% African American, and 1% Asian.

Table 2. Adverse Reactions in Patients with Cancer Receiving Myelosuppressive Chemotherapy (With ≥ 5% Higher Incidence in Filgrastim Compared to Placebo) System Organ Class Preferred Term Filgrastim (N = 294) Placebo (N = 157) Blood and lymphatic system disorders Thrombocytopenia 38% 29% Gastrointestinal disorders Nausea 43% 32% General disorders and administration site conditions Pyrexia 48% 29% Chest pain 13% 6% Pain 12% 6% Fatigue 20% 10% Musculoskeletal and connective tissue disorders Back pain 15% 8% Arthralgia 9% 2% Bone pain 11% 6% Pain in extremity Percent difference (Filgrastim – Placebo) was 4%.

7% 3% Nervous system disorders Dizziness 14% 3% Respiratory, thoracic and mediastinal disorders Cough 14% 8% Dyspnea 13% 8% Skin and subcutaneous tissue disorders Rash 14% 5% Investigations Blood lactate dehydrogenase increased 6% 1% Blood alkaline phosphatase incre… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with filgrastim products use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . Reports in the scientific literature have described transplacental passage of filgrastim in pregnant women when administered ≤ 30 hours prior to preterm delivery (≤ 30 weeks gestation).

In animal reproduction studies, effects of filgrastim on prenatal development have been studied in rats and rabbits. No malformations were observed in either species. No maternal or fetal effects were observed in pregnant rats at doses up to 58 times the human doses.

Filgrastim has been shown to have adverse effects in pregnant rabbits at doses 2 to 10 times higher than the human doses (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations 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 Human data Several observational studies based on the Severe Chronic Neutropenia International Registry (SCNIR) described pregnancy outcomes in women with severe chronic neutropenia (SCN) who were exposed to filgrastim products during pregnancy and women with SCN who were unexposed. No major differences were seen between treated and untreated women with respect to pregnancy outcome (including miscarriage and preterm labor), newborn complications (including birth weight) and infections.

Methodological limitations of these studies, include small sample size, and lack of generalizability due to the underlying maternal condition. Animal data Effects of filgrastim on prenatal development have been studied in rats and rabbits. No malformations were observed in either species.

Filgrastim has been shown to have adverse effects in pregnant rabbits at doses 2 to 10 times higher than the human doses. In pregnant rabbits showing signs of maternal toxicity, reduced embryo-fetal survival (at 20 and 80 mcg/kg/day) and increased abortions (at 80 mcg/kg/day) were observed. In pregnant rats, no maternal or fetal effects were observed at doses up to 575 mcg/kg/day, which is approximately 58 times higher than the human dose of 10 mcg/kg/day.

Offspring of rats administered filgrastim during the peri-natal and lactation periods exhibited a delay in external differentiation and growth retardation (≥ 20 mcg/kg/day) and slightly reduced survival rate (100 mcg/kg/day).

8.2Lactation Risk Summary There is published literature documenting transfer of filgrastim into human milk. There are a few case reports describing the use of filgrastim in breastfeeding mothers with no adverse effects noted in the infants. There are no data on the effects of filgrastim products 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 NIVESTYM and any potential adverse effects on the breastfed child from NIVESTYM or from the underlying maternal condition.

8.4Pediatric Use NIVESTYM prefilled syringe with BD UltraSafe Plus™ Passive Needle Guard may not accurately measure volumes less than 0.3 mL due to the needle spring mechanism design. Therefore, the direct administration of a volume less than 0.3 mL using NIVESTYM prefilled syringe is not recommended due to the potential for dosing errors. For direct administration of doses less than 0.3 mL (180 mcg) use NIVESTYM single-dose vial.

In patients with cancer receiving myelosuppre… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with filgrastim products use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . Reports in the scientific literature have described transplacental passage of filgrastim in pregnant women when administered ≤ 30 hours prior to preterm delivery (≤ 30 weeks gestation).

In animal reproduction studies, effects of filgrastim on prenatal development have been studied in rats and rabbits. No malformations were observed in either species. No maternal or fetal effects were observed in pregnant rats at doses up to 58 times the human doses.

Filgrastim has been shown to have adverse effects in pregnant rabbits at doses 2 to 10 times higher than the human doses (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations 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 Human data Several observational studies based on the Severe Chronic Neutropenia International Registry (SCNIR) described pregnancy outcomes in women with severe chronic neutropenia (SCN) who were exposed to filgrastim products during pregnancy and women with SCN who were unexposed. No major differences were seen between treated and untreated women with respect to pregnancy outcome (including miscarriage and preterm labor), newborn complications (including birth weight) and infections.

Methodological limitations of these studies, include small sample size, and lack of generalizability due to the underlying maternal condition. Animal data Effects of filgrastim on prenatal development have been studied in rats and rabbits. No malformations were observed in either species.

Filgrastim has been shown to have adverse effects in pregnant rabbits at doses 2 to 10 times higher than the human doses. In pregnant rabbits showing signs of maternal toxicity, reduced embryo-fetal survival (at 20 and 80 mcg/kg/day) and increased abortions (at 80 mcg/kg/day) were observed. In pregnant rats, no maternal or fetal effects were observed at doses up to 575 mcg/kg/day, which is approximately 58 times higher than the human dose of 10 mcg/kg/day.

Offspring of rats administered filgrastim during the peri-natal and lactation periods exhibited a delay in external differentiation and growth retardation (≥ 20 mcg/kg/day) and slightly reduced survival rate (100 mcg/kg/day).

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use NIVESTYM prefilled syringe with BD UltraSafe Plus™ Passive Needle Guard may not accurately measure volumes less than 0.3 mL due to the needle spring mechanism design. Therefore, the direct administration of a volume less than 0.3 mL using NIVESTYM prefilled syringe is not recommended due to the potential for dosing errors. For direct administration of doses less than 0.3 mL (180 mcg) use NIVESTYM single-dose vial.

In patients with cancer receiving myelosuppressive chemotherapy‚ 15 pediatric patients median age 2.6 (range 1.2 to 9.4) years with neuroblastoma were treated with myelosuppressive chemotherapy (cyclophosphamide‚ cisplatin‚ doxorubicin‚ and etoposide) followed by subcutaneous filgrastim at doses of 5, 10, or 15 mcg/kg/day for 10 days (n = 5/dose) (Study 8). The pharmacokinetics of filgrastim in pediatric patients after chemotherapy were similar to those in adults receiving the same weight-normalized doses, suggesting no age-related differences in the pharmacokinetics of filgrastim.

In this population‚ filgrastim was well-tolerated. There was one report of palpable splenomegaly and one report of hepatosplenomegaly associated with filgrastim therapy; however‚ the only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population. The safety and effectiveness of NIVESTYM have been established in pediatric patients with SCN [see Clinical Studies (14.5) ] .

Use of NIVESTYM for this indication is supported by NIVESTYM’s approval as a biosimilar to filgrastim and evidence from a phase 3 study (Study 7) to assess the safety and efficacy of filgrastim in the treatment of SCN where 123 patients with a median age of 12 years (range 7 months to 76 years) were studied. Of the 123 patients, 12 were infants (7 months to 2 years of age), 49 were children (2 to 12 years of age), and 9 were adolescents (12 to 16 years of age). Additional information is available from a SCN postmarketing surveillance study, which includes long-term follow-up of patients in the clinical studies and information from additional patients who entered directly into the postmarketing surveillance study.

Of the 731 patients in the surveillance study, 429 were pediatric patients < 18 years of age (range 0.9 to 17) [see Indications and Usage (1.5) , Dosage and Administration (2.5) , and Clinical Studies (14.5) ] . Long-term follow-up data from the postmarketing surveillance study suggest that height and weight are not adversely affected in patients who received up to 5 years of filgrastim treatment. Limited data from patients who were followed in the phase 3 study for 1.5 years did not suggest alterations in sexual maturation or endocrine function.

Pediatric patients with congenital types of neutropenia (Kostmann's syndrome, congenital agranulocytosis, or Schwachman-Diamond syndrome) have developed cytogenetic abnormalities and have undergone transformation to MDS and AML while receiving chronic filgrastim treatment. The relationship of these events to filgrastim product administration is unknown [see Warnings and Precautions (5.8) and Adverse Reactions (6) ] .

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use Among 855 subjects enrolled in 3 randomized, placebo-controlled trials of filgrastim-treated patients receiving myelosuppressive chemotherapy, there were 232 subjects age 65 or older, and 22 subjects age 75 or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Clinical studies of filgrastim in other approved indications (i.e., BMT recipients, PBPC mobilization, and SCN) did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects.

🆘 Overdosage 79 words ▾

10 OVERDOSAGE The maximum tolerated dose of filgrastim products has not been determined. In filgrastim clinical trials of patients with cancer receiving myelosuppressive chemotherapy‚ WBC counts > 100‚000/mm 3 have been reported in less than 5% of patients‚ but were not associated with any reported adverse clinical effects. Patients in the BMT studies received up to 138 mcg/kg/day without toxic effects‚ although there was a flattening of the dose response curve above daily doses of greater than 10 mcg/kg/day.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation‚ differentiation commitment‚ and some end-cell functional activation. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes‚ fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation‚ differentiation, and selected end-cell functions (including enhanced phagocytic ability‚ priming of the cellular metabolism associated with respiratory burst‚ antibody-dependent killing, and the increased expression of some cell surface antigens).

G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage.

12.2Pharmacodynamics In phase 1 studies involving 96 patients with various non-myeloid malignancies‚ filgrastim administration resulted in a dose-dependent increase in circulating neutrophil counts over the dose range of 1 to 70 mcg/kg/day. This increase in neutrophil counts was observed whether filgrastim was administered intravenous (1 to 70 mcg/kg twice daily)‚ subcutaneous (1 to 3 mcg/kg once daily)‚ or by continuous subcutaneous infusion (3 to 11 mcg/kg/day). With discontinuation of filgrastim therapy‚ neutrophil counts returned to baseline in most cases within 4 days.

Isolated neutrophils displayed normal phagocytic (measured by zymosan-stimulated chemoluminescence) and chemotactic (measured by migration under agarose using N-formyl-methionyl-leucyl-phenylalanine [fMLP] as the chemotaxin) activity in vitro. The absolute monocyte count was reported to increase in a dose-dependent manner in most patients receiving filgrastim; however‚ the percentage of monocytes in the differential count remained within the normal range. Absolute counts of both eosinophils and basophils did not change and were within the normal range following administration of filgrastim.

Increases in lymphocyte counts following filgrastim administration have been reported in some normal subjects and patients with cancer. White blood cell (WBC) differentials obtained during clinical trials have demonstrated a shift towards earlier granulocyte progenitor cells (left shift)‚ including the appearance of promyelocytes and myeloblasts‚ usually during neutrophil recovery following the chemotherapy-induced nadir. In addition‚ Dohle bodies‚ increased granulocyte granulation‚ and hypersegmented neutrophils have been observed.

Such changes were transient and were not associated with clinical sequelae, nor were they necessarily associated with infection.

12.3Pharmacokinetics Filgrastim products exhibit nonlinear pharmacokinetics. Clearance is dependent on filgrastim product concentration and neutrophil count: G-CSF receptor-mediated clearance is saturated by high concentration of filgrastim products and is diminished by neutropenia. In addition, filgrastim products are cleared by the kidney.

Subcutaneous administration of 3.45 mcg/kg and 11.5 mcg/kg of filgrastim resulted in maximum serum concentrations of 4 and 49 ng/mL‚ respectively‚ within 2 to 8 hours. After intravenous administration, the volume of distribution averaged 150 mL/kg and the elimination half-life was approximately 3.5 hours in both normal subjects and cancer subjects. Clearance rates of filgrastim were approximately 0.5 to 0.7 mL/minute/kg.

Single parenteral doses or daily intravenous doses‚ over a 14-day period‚ resulted in comparable half-lives. The half-lives were similar for intravenous administration (231 minutes‚ following doses of 34.5 mcg/kg) and for subcutaneous administration (210 minutes‚ following filgrastim dosages of 3.45 mcg/kg). Continuous 24-hour intravenous infusions of 20 mcg/kg over an 11 to 20-day period produced steady-state ser… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 122 words ▾

12.1Mechanism of Action Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation‚ differentiation commitment‚ and some end-cell functional activation. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes‚ fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation‚ differentiation, and selected end-cell functions (including enhanced phagocytic ability‚ priming of the cellular metabolism associated with respiratory burst‚ antibody-dependent killing, and the increased expression of some cell surface antigens).

G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage.

📦 How Supplied / Storage and Handling 195 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING NIVESTYM injection is a clear, colorless, preservative-free solution supplied as: Vials Single-dose vials containing 300 mcg/mL of filgrastim-aafi solution. Dispensing packs of 10 vials (NDC 0069-0293-10). Single-dose vials containing 480 mcg/1.6 mL (300 mcg/mL) of filgrastim-aafi solution.

Dispensing packs of 10 vials (NDC 0069-0294-10). Prefilled Syringes Single-dose prefilled syringe with BD UltraSafe Plus™ Passive Needle Guard, containing 300 mcg/0.5 mL of filgrastim-aafi solution. • Pack of 1 prefilled syringe (NDC 0069-0291-01). • Pack of 10 prefilled syringes (NDC 0069-0291-10). Single-dose, prefilled syringe with BD UltraSafe Plus™ Passive Needle Guard, containing 480 mcg/0.8 mL of filgrastim-aafi solution. • Pack of 1 prefilled syringe (NDC 0069-0292-01). • Pack of 10 prefilled syringes (NDC 0069-0292-10).

The NIVESTYM syringe plunger stopper and needle cover are not made with natural rubber latex [see Dosage and Administration (2.5) ] . Storage Store NIVESTYM in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not leave NIVESTYM in direct sunlight.

Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard NIVESTYM if frozen more than once. Avoid shaking.

Transport via a pneumatic tube has not been studied.

📦 Storage and Handling 56 words ▾

Storage Store NIVESTYM in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not leave NIVESTYM in direct sunlight. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard NIVESTYM if frozen more than once. Avoid shaking. Transport via a pneumatic tube has not been studied.

📋 Description ~1 min read ▾

11 DESCRIPTION Filgrastim-aafi is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. NIVESTYM is produced by Escherichia coli ( E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NIVESTYM has a molecular weight of 18‚799 daltons.

The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli . Because NIVESTYM is produced in E coli ‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NIVESTYM is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim-aafi injection for subcutaneous or intravenous use.

The product is available in single-dose vials for subcutaneous or intravenous use and prefilled syringes for subcutaneous use. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-aafi. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-aafi.

The final pH range of the NIVESTYM drug product solution is 3.8 to 4.3. See Table 4 below for product composition of each single-dose vial or prefilled syringe. Table 4.

Product Composition 300 mcg/mL Vial 480 mcg/1.6 mL Vial 300 mcg/0.5 mL Syringe 480 mcg/0.8 mL Syringe Filgrastim-aafi 300 mcg 480 mcg 300 mcg 480 mcg Acetate 0.59 mg 0.94 mg 0.295 mg 0.472 mg Polysorbate 80 0.04 mg 0.064 mg 0.02 mg 0.032 mg Sodium 0.035 mg 0.056 mg 0.0175 mg 0.028 mg Sorbitol 50 mg 80 mg 25 mg 40 mg Water for Injection USP q.s. ad quantity sufficient to make 1 mL 1.6 mL 0.5 mL 0.8 mL

💬 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). Review the steps for direct patient administration with patients and caregivers. Training by the healthcare provider should aim to ensure that patients and caregivers can successfully perform all of the steps in the Instructions for Use of NIVESTYM vial and prefilled syringe, including showing the patient or caregiver how to measure the required dose, particularly if a patient is on a dose other than the entire prefilled syringe.

If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of NIVESTYM or whether the patient would benefit from a different NIVESTYM presentation. Advise patients of the following risks and potential risks with NIVESTYM: • Rupture or enlargement of the spleen may occur. Symptoms include left upper quadrant abdominal pain or left shoulder pain.

Advise patients to report pain in these areas to their physician immediately [see Warnings and Precautions (5.1) ] . • Dyspnea, with or without fever, progressing to Acute Respiratory Distress Syndrome, may occur. Advise patients to report dyspnea to their physician immediately [see Warnings and Precautions (5.2) ] . • Serious allergic reactions may occur, which may be signaled by rash‚ facial edema‚ wheezing‚ dyspnea‚ hypotension‚ or tachycardia. Advise patients to seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur [see Warnings and Precautions (5.3) ] . • In patients with sickle cell disease, sickle cell crisis and death have occurred.

Discuss potential risks and benefits for patients with sickle cell disease prior to the administration of human granulocyte colony-stimulating factors [see Warnings and Precautions (5.4) ] . • Glomerulonephritis may occur. Symptoms include swelling of the face or ankles, dark colored urine or blood in the urine, or a decrease in urine production. Advise patients to report signs or symptoms of glomerulonephritis to their physician immediately [see Warnings and Precautions (5.5) ] . • There may be an increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with congenital neutropenia who receive filgrastim products and in patients with breast and lung cancer who receive filgrastim products in conjunction with chemotherapy and/or radiation therapy.

Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Advise patients to report to their physician signs and symptoms of MDS/AML [see Warnings and Precautions (5.8) ] . • Cutaneous vasculitis may occur, which may be signaled by purpura or erythema. Advise patients to report signs or symptoms of vasculitis to their physician immediately [see Warnings and Precautions (5.11) ] . • Aortitis may occur.

Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Advise patients to report signs and symptoms of aortitis to their physician immediately [see Warnings and Precautions (5.15) ] . Instruct patients who self-administer NIVESTYM using the prefilled syringe or single-dose vial of the: • Importance of following the applicable Instructions for Use. • Dangers of reusing needles, syringes, or unused portions of single-dose vials. • Importance of following local requirements for proper disposal of used syringes, needles, and unused vials. • Importance of informing the healthcare provider if difficulty occurs when measuring or administering partial contents of the NIVESTYM prefilled syringe.

If difficulty occurs, use of the NIVESTYM vial may be considered. • Difference in product concentration of the NIVESTYM prefilled syringe in comparison to the NIVESTYM vial. When switching patients from the NIVESTYM prefilled syringe to the NIVESTYM vial, or vice versa, ensure… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Filgrastim products exhibit nonlinear pharmacokinetics. Clearance is dependent on filgrastim product concentration and neutrophil count: G-CSF receptor-mediated clearance is saturated by high concentration of filgrastim products and is diminished by neutropenia. In addition, filgrastim products are cleared by the kidney.

Subcutaneous administration of 3.45 mcg/kg and 11.5 mcg/kg of filgrastim resulted in maximum serum concentrations of 4 and 49 ng/mL‚ respectively‚ within 2 to 8 hours. After intravenous administration, the volume of distribution averaged 150 mL/kg and the elimination half-life was approximately 3.5 hours in both normal subjects and cancer subjects. Clearance rates of filgrastim were approximately 0.5 to 0.7 mL/minute/kg.

Single parenteral doses or daily intravenous doses‚ over a 14-day period‚ resulted in comparable half-lives. The half-lives were similar for intravenous administration (231 minutes‚ following doses of 34.5 mcg/kg) and for subcutaneous administration (210 minutes‚ following filgrastim dosages of 3.45 mcg/kg). Continuous 24-hour intravenous infusions of 20 mcg/kg over an 11 to 20-day period produced steady-state serum concentrations of filgrastim with no evidence of drug accumulation over the time period investigated.

The absolute bioavailability of filgrastim after subcutaneous administration is 60% to 70%. Specific Populations Pediatric Patients The pharmacokinetics of filgrastim in pediatric patients after chemotherapy are similar to those in adult patients receiving the same weight-normalized doses, suggesting no age-related differences in the pharmacokinetics of filgrastim products [see Use in Specific Populations (8.4) ] . Renal Impairment In a study with healthy volunteers, subjects with moderate renal impairment, and subjects with end-stage renal disease (n = 4 per group), higher serum concentrations were observed in subjects with end-stage renal disease.

However, dose adjustment in patients with renal impairment is not necessary. Hepatic Impairment Pharmacokinetics and pharmacodynamics of filgrastim are similar between subjects with hepatic impairment and healthy subjects (n = 12/group). The study included 10 subjects with mild hepatic impairment (Child-Pugh Class A) and 2 subjects with moderate hepatic impairment (Child-Pugh Class B).

Therefore, NIVESTYM dose adjustment for patients with hepatic impairment is not necessary.

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics In phase 1 studies involving 96 patients with various non-myeloid malignancies‚ filgrastim administration resulted in a dose-dependent increase in circulating neutrophil counts over the dose range of 1 to 70 mcg/kg/day. This increase in neutrophil counts was observed whether filgrastim was administered intravenous (1 to 70 mcg/kg twice daily)‚ subcutaneous (1 to 3 mcg/kg once daily)‚ or by continuous subcutaneous infusion (3 to 11 mcg/kg/day). With discontinuation of filgrastim therapy‚ neutrophil counts returned to baseline in most cases within 4 days.

Isolated neutrophils displayed normal phagocytic (measured by zymosan-stimulated chemoluminescence) and chemotactic (measured by migration under agarose using N-formyl-methionyl-leucyl-phenylalanine [fMLP] as the chemotaxin) activity in vitro. The absolute monocyte count was reported to increase in a dose-dependent manner in most patients receiving filgrastim; however‚ the percentage of monocytes in the differential count remained within the normal range. Absolute counts of both eosinophils and basophils did not change and were within the normal range following administration of filgrastim.

Increases in lymphocyte counts following filgrastim administration have been reported in some normal subjects and patients with cancer. White blood cell (WBC) differentials obtained during clinical trials have demonstrated a shift towards earlier granulocyte progenitor cells (left shift)‚ including the appearance of promyelocytes and myeloblasts‚ usually during neutrophil recovery following the chemotherapy-induced nadir. In addition‚ Dohle bodies‚ increased granulocyte granulation‚ and hypersegmented neutrophils have been observed.

Such changes were transient and were not associated with clinical sequelae, nor were they necessarily associated with infection.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Patients with Cancer Receiving Myelosuppressive Chemotherapy The safety and efficacy of filgrastim to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs were established in a randomized‚ double-blind‚ placebo-controlled trial conducted in patients with small cell lung cancer (Study 1). In Study 1, patients received up to 6 cycles of intravenous chemotherapy including intravenous cyclophosphamide and doxorubicin on day 1; and etoposide on days 1, 2, and 3 of 21 day cycles.

Patients were randomized to receive filgrastim (n = 99) at a dose of 230 mcg/m 2 (4 to 8 mcg/kg/day) or placebo (n = 111). Study drug was administered subcutaneously daily beginning on day 4, for a maximum of 14 days. A total of 210 patients were evaluable for efficacy and 207 were evaluable for safety.

The demographic and disease characteristics were balanced between arms with a median age of 62 (range 31 to 80) years; 64% males; 89% Caucasian; 72% extensive disease and 28% limited disease. The main efficacy endpoint was the incidence of febrile neutropenia. Febrile neutropenia was defined as an ANC < 1,000/mm 3 and temperature > 38.2°C.

Treatment with filgrastim resulted in a clinically and statistically significant reduction in the incidence of infection‚ as manifested by febrile neutropenia, 40% for filgrastim-treated patients and 76% for placebo-treated patients (p < 0.001). There were also statistically significant reductions in the incidence and overall duration of infection manifested by febrile neutropenia; the incidence, severity and duration of severe neutropenia (ANC < 500/mm 3 ); the incidence and overall duration of hospital admissions; and the number of reported days of antibiotic use.

14.2Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy The safety and efficacy of filgrastim to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) was established in a randomized, double-blind‚ placebo-controlled‚ multi-center trial in patients with newly diagnosed, de novo AML (Study 4). In Study 4 the initial induction therapy consisted of intravenous daunorubicin days 1, 2, and 3; cytosine arabinoside days 1 to 7; and etoposide days 1 to 5.

Patients were randomized to receive subcutaneous filgrastim (n = 259) at a dose of 5 mcg/kg/day or placebo (n = 262) from 24 hours after the last dose of chemotherapy until neutrophil recovery (ANC ≥ 1,000/mm 3 for 3 consecutive days or ≥ 10,000/mm 3 for 1 day) or for a maximum of 35 days. The demographic and disease characteristics were balanced between arms with a median age of 54 (range 16 to 89) years; 54% males; initial white blood cell count (65% < 25,000/mm 3 and 27% > 100,000/mm 3 ); 29% unfavorable cytogenetics.

The main efficacy endpoint was median duration of severe neutropenia defined as neutrophil count < 500/mm 3 . Treatment with filgrastim resulted in a clinically and statistically significant reduction in median number of days of severe neutropenia, filgrastim-treated patients 14 days, placebo-treated patients 19 days (p = 0.0001: difference of 5 days (95% CI: -6.0, -4.0)). There was a reduction in the median duration of intravenous antibiotic use, filgrastim-treated patients: 15 days versus placebo-treated patients: 18.5 days; a reduction in the median duration of hospitalization, filgrastim-treated patients: 20 days versus placebo-treated patients: 25 days.

There were no statistically significant differences between the filgrastim and the placebo groups in complete remission rate (69% - filgrastim, 68% - placebo), median time to progression of all randomized patients (165 days - filgrastim, 186 days - placebo), or median overall survival (380 days - filgrastim, 425 days - placebo).

14.3Patients with Cancer Undergoing… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 154 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of filgrastim products has not been studied. Filgrastim failed to induce bacterial gene mutations in either the presence or absence of a drug metabolizing enzyme system. Filgrastim had no observed effect on the fertility of male or female rats at doses up to 500 mcg/kg.

13.2Animal Toxicology and Pharmacology Filgrastim was administered to monkeys‚ dogs‚ hamsters‚ rats‚ and mice as part of a nonclinical toxicology program, which included studies up to 1 year duration. In the repeated-dose studies‚ changes observed were attributable to the expected pharmacological actions of filgrastim (i.e.‚ dose-dependent increases in white blood cell counts‚ increased circulating segmented neutrophils‚ and increased myeloid: erythroid ratio in bone marrow). Histopathologic examination of the liver and spleen revealed evidence of ongoing extramedullary granulopoiesis, and dose-related increases in spleen weight were seen in all species.

These changes all reversed after discontinuation of treatment.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 54 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of filgrastim products has not been studied. Filgrastim failed to induce bacterial gene mutations in either the presence or absence of a drug metabolizing enzyme system. Filgrastim had no observed effect on the fertility of male or female rats at doses up to 500 mcg/kg.

📄 Patient Package Insert ~3 min read ▾

Patient Information NIVESTYM ( Neye-ves-tim ) (filgrastim-aafi) injection What is NIVESTYM? NIVESTYM is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body.

It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection. Do not take NIVESTYM if you have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products. Before you take NIVESTYM, tell your healthcare provider about all of your medical conditions, including if you: • have a sickle cell disorder. • have kidney problems. • are receiving radiation therapy. • are pregnant or plan to become pregnant.

It is not known if NIVESTYM will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if NIVESTYM passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive NIVESTYM? • NIVESTYM injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If NIVESTYM is given at home, see the detailed " Instructions for Use " that comes with your NIVESTYM for information on how to prepare and inject a dose of NIVESTYM. • You and your caregiver should be shown how to prepare and inject NIVESTYM before you use it, by your healthcare provider. • You should not try to inject a dose of NIVESTYM less than 0.3 mL (180 mcg) from a NIVESTYM prefilled syringe.

A dose less than 0.3 mL cannot be accurately measured using the NIVESTYM prefilled syringe. • Your healthcare provider will tell you how much NIVESTYM to inject and when to inject it. Do not change your dose or stop NIVESTYM unless your healthcare provider tells you to. • If you are receiving NIVESTYM because you are also receiving chemotherapy, your dose of NIVESTYM should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your NIVESTYM dose. • If you miss a dose of NIVESTYM, talk to your healthcare provider about when you should give your next dose.

What are the possible side effects of NIVESTYM? NIVESTYM 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 (abdomen) area or your left shoulder. • A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical 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.

NIVESTYM can cause serious allergic reactions. These 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 NIVESTYM and call your healthcare provider or get emergency medical help right away. • Sickle cell crises.

You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive NIVESTYM. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing. • Kidney injury (glomerulonephritis). NIVESTYM can cause 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 • Capillary leak syndrome. NIVESTYM can cause fluid to leak from blood vessels into your body's tissues. This condition i… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use NIVESTYM (Neye-ves-tim) (filgrastim-aafi) injection Single-Dose Prefilled Syringe Important Read the Patient Information for important information you need to know about NIVESTYM before using this Instructions for Use. Before you use a NIVESTYM prefilled syringe, read this important information. Storing your prefilled syringe • Store the NIVESTYM prefilled syringe in the refrigerator between 36˚F to 46˚F (2˚C to 8˚C). • Do not freeze. • Keep the NIVESTYM 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 before preparing an injection. • The NIVESTYM prefilled syringe may be allowed to reach room temperature for up to 24 hours.

Throw away (dispose of) any NIVESTYM prefilled syringe that has been left at room temperature for longer than 24 hours. • After you inject your dose, throw away (dispose of) any unused NIVESTYM left in the prefilled syringe. Do not save unused NIVESTYM in the prefilled syringe for later use. • Keep NIVESTYM and all medicines out of the reach of children. Using your 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. • You should not inject a dose of NIVESTYM less than 0.3 mL (180 mcg) from a NIVESTYM prefilled syringe.

A dose less than 0.3 mL cannot be accurately measured using the NIVESTYM prefilled syringe. • Make sure the name NIVESTYM appears on the carton and prefilled syringe label. • Do not use a NIVESTYM prefilled syringe after the expiration date on the label. • Do not shake the NIVESTYM prefilled syringe. • The prefilled syringe has a needle guard that needs to be activated to cover the needle after the injection is given. The needle guard will help prevent needle stick injuries to anyone who handles the prefilled syringe. • Do not remove the needle cover from the prefilled syringe until you are ready to inject. • Do not use the NIVESTYM prefilled syringe if the needle cover is missing. • 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. Call your healthcare provider if you have any questions.

About the NIVESTYM prefilled syringe • NIVESTYM prefilled syringes come in two strengths. Depending on your prescription, you will receive NIVESTYM prefilled syringes that contain 300 mcg/0.5 mL or 480 mcg/0.8 mL of medicine. Your healthcare provider will determine the dose in milliliters (mL) that you will need to give based on your body weight. • When you receive your NIVESTYM prefilled syringes, always check to see that the: o name NIVESTYM appears on the carton and prefilled syringe label. o expiration date on the prefilled syringe label has not passed.

You should not use a prefilled syringe after the date on the label. o strength of NIVESTYM (number of micrograms on the carton containing the prefilled syringe) is the same as what your healthcare provider prescribed. NIVESTYM prefilled syringe parts (see Figure A ). NIVESTYM 300 mcg/0.5 mL prefilled syringe is shown as an example.

Figure A What you need for your injection Included in the carton: • 1 new NIVESTYM prefilled syringe (see Figure A above) Not included in the carton (see Figure B ) • 1 adhesive bandage • 1 alcohol wipe • 1 cotton ball or gauze • sharps disposal container Figure B Preparing the NIVESTYM prefilled syringe Step 1: Find a clean, well-lit flat work surface. Step 2: Take the carton containing the NIVESTYM prefilled syringe out of the refrigerator and leave it unopened on your work surface for at least 30 minutes so that it reaches room temperature.

Put the original carton with any unused prefilled syringes back in the refrigerator. • Do not shake the prefilled syringe. •… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL - 1 mL Vial Label NDC 0069-0293-01 Rx Only Nivestym™ (filgrastim-aafi) Injection 300 mcg/mL 1 mL Single-Dose Vial Pfizer PRINCIPAL DISPLAY PANEL - 1 mL Vial Label

PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton 10 x 300 mcg/mL Single-Dose Vials (containing 1 mL) Discard unused portion NDC 0069-0293-10 Rx Only Nivestym™ (filgrastim-aafi) Injection 300 mcg/mL A recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli For Intravenous or Subcutaneous Use Only Sterile Solution - No Preservative Pfizer Oncology PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 1.6 mL Vial Label NDC 0069-0294-01 Rx Only Nivestym™ (filgrastim-aafi) Injection 480 mcg/1.6 mL (300 mcg/mL) 1.6 mL Single-Dose Vial Pfizer PRINCIPAL DISPLAY PANEL - 1.6 mL Vial Label

PRINCIPAL DISPLAY PANEL - 1.6 mL Vial Carton 10 x 480 mcg/1.6 mL Single-Dose Vials (containing 1.6 mL) Discard unused portion NDC 0069-0294-10 Rx Only Nivestym™ (filgrastim-aafi) Injection 480 mcg/1.6 mL (300 mcg/mL) A recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli For Intravenous or Subcutaneous Use Only Sterile Solution - No Preservative Pfizer Oncology PRINCIPAL DISPLAY PANEL - 1.6 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label NDC 0069-0291-01 Rx Only Nivestym™ (filgrastim-aafi) Injection 300 mcg/0.5 mL Single-Dose Prefilled Syringe with Needle Guard For Subcutaneous Use Only Mfd by Hospira Inc, a Pfizer Company, Lake Forest, IL 60045 USA US License No. 1974 PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton 1 x 300 mcg/0.5 mL Single-Dose Prefilled Syringe with Needle Guard Discard unused portion. Refrigerate at 2° to 8°C (36° to 46°F). Do Not Freeze or Shake.

Protect from light. Subcutaneous Use Only Nivestym™ (filgrastim-aafi) Injection 300 mcg/0.5 mL A recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli Pfizer Oncology NDC 0069-0291-01 Rx Only The syringe plunger stopper and needle cover are not made with natural rubber latex. Sterile Solution - No Preservative PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton - NDC 0069-0291-10 NDC 0069-0291-10 Rx Only Nivestym™ (filgrastim-aafi) Injection 300 mcg/0.5 mL 10 x 300 mcg/0.5 mL Single-Dose Prefilled Syringe with Needle Guard Discard unused portion. A recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli Subcutaneous Use Only Sterile Solution - No Preservative Pfizer Oncology PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton - NDC 0069-0291-10

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton - NDC 0069-0291-01 NDC 0069-0291-01 Rx Only Nivestym™ (filgrastim-aafi) Injection 300 mcg/0.5 mL A recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli 1 x 300 mcg/0.5 mL Single-Dose Prefilled Syringe with Needle Guard Discard unused portion. Subcutaneous Use Only Sterile Solution - No Preservative Pfizer Oncology PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton - NDC 0069-0291-01

PRINCIPAL DISPLAY PANEL - 0.8 mL Syringe Label NDC 0069-0292-01 Rx Only Nivestym™ (filgrastim-aafi) Injection 480 mcg/0.8 mL Single-Dose Prefilled Syringe with Needle Guard For Subcutaneous Use Only Mfd by Hospira Inc, a Pfizer Company, Lake Forest, IL 60045 USA US License No. 1974 PRINCIPAL DISPLAY PANEL - 0.8 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 0.8 mL Syringe Carton 1 x 480 mcg/0.8 mL Single-Dose Prefilled Syringe with Needle Guard Discard unused portion. Refrigerate at 2° to 8°C (36° to 46°F). Do Not Freeze or Shake.

Protect from light. Subcutaneous Use Only NDC 0069-0292-01 Rx Only Nivestym™ (filgrastim-aafi) Injection 480 mcg/0.8 mL A recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli Pfizer Oncology The syringe plunger stopper and needle cover are not made with natural rubber latex. Sterile Solution - No Preservative PRINCIPAL DISPLAY PANEL - 0.8 mL Syringe C… [Excerpted — this section continues on DailyMed.]

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
2.1K
Units reimbursed last 4 qtrs
2.7K
Gross reimbursed last 4 qtrs
$943.1K
Avg / prescription
$460.05
Avg / unit
$355.40
Latest quarter Q1 2026
295Rx
Fee-for-service vs managed care ⓘ
38% FFS 62% MCO
Fee-for-service · 778 Rx Managed care · 1,272 Rx
State Medicaid map
Alaska: 17 units · 2.3 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 12 units · 0.2 per 100k residents MN Wisconsin: no data reported WI Michigan: 19 units · 0.2 per 100k residents MI New York: 163 units · 0.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 23 units · 2.5 per 100k residents SD Iowa: no data reported IA Illinois: 16 units · 0.1 per 100k residents IL Indiana: no data reported IN Ohio: 152 units · 1.3 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 144 units · 1.6 per 100k residents NJ Massachusetts: 41 units · 0.6 per 100k residents MA California: 1,352 units · 3.5 per 100k residents CA Utah: 8 units · 0.2 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 249 units · 3.4 per 100k residents AZ New Mexico: 9 units · 0.4 per 100k residents NM Kansas: 57 units · 1.9 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 11 units · 0.2 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 51 units · 1.0 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 33 units · 0.1 per 100k residents TX Florida: 298 units · 1.3 per 100k residents FL
Units reimbursed · per 100k residents
0.13.5
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 California 3.5 /100k
2 Arizona 3.4 /100k
3 South Dakota 2.5 /100k
4 Alaska 2.3 /100k
5 Kansas 1.9 /100k
6 New Jersey 1.6 /100k
7 Florida 1.3 /100k
8 Ohio 1.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 syringe this page00069-0291-01 2,050 Rx · $943,094
1 syringe00069-0291-10 800 Rx · $668,929
Drug total (last 4 qtrs): 2,850 Rx · 4,329 units · $1,612,023 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Nivestym — 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 Nivestym. 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
$5M
Claims incl. refills
3.1K
Beneficiaries
1.7K
Spend / beneficiary
$2,879.43
Spend / claim
$1,593.46
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 Nivestym (this brand).

Top reported reactions

Death91
White Blood Cell Count Decreased38
Fatigue23
Pyrexia23
Diarrhoea22
Hospitalisation22
Malaise19

Age at onset

Adult32
Elderly20

Reporter sex

641 reports
Male · 42%
Female · 58%

Serious outcomes

Hospitalization181
Death112
Disabling5
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 122 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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 syringe (00069-0291-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
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 Q5110 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.
← 00069-0284-03 · Pfizer 00069-0292-01 · 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.