Pegfilgrastim Injection
Pegfilgrastim injection (Fulphila, Fylnetra, Neulasta, UDENYCA) is a white blood cell growth factor used to reduce the risk of serious infection in cancer patients receiving chemotherapy, and to improve survival after exposure to dangerously high doses of radiation.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Pegfilgrastim Injection: Patient Information Guide
A plain-language walkthrough of Pegfilgrastim Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Pegfilgrastim injection (available as Fulphila, Fylnetra, Neulasta, and UDENYCA) is a white blood cell growth factor approved for the following uses:
- Reducing the risk of febrile neutropenia (dangerous infection caused by severely low white blood cell counts) in adults and children with non-myeloid cancers receiving myelosuppressive (bone marrow-suppressing) chemotherapy — this is an indication for Neulasta and its biosimilars Fulphila, Fylnetra, and UDENYCA
- Increasing survival in adults and children acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) — this is an indication for Neulasta and its biosimilars
- Not approved for mobilizing stem cells for bone marrow (hematopoietic stem cell) transplantation
⚙️How it works▾
Pegfilgrastim is a colony-stimulating factor — a lab-made protein similar to one your body produces naturally. It binds to specific receptors on the surface of blood-forming cells in the bone marrow, sending signals that tell those cells to grow, divide, and mature into neutrophils (a key type of infection-fighting white blood cell). By boosting neutrophil production, pegfilgrastim helps restore the immune system's ability to fight bacteria and other infections after chemotherapy or radiation has damaged the bone marrow.
The drug's clearance from the body is closely tied to neutrophil levels — as neutrophil counts recover, the body clears pegfilgrastim more quickly. This self-regulating behavior helps match the drug's activity to the body's need for white blood cell support.
💊How it's taken▾
Pegfilgrastim is given as a subcutaneous injection (a shot just under the skin). For chemotherapy patients, it is given once per chemotherapy cycle and must not be administered in the 14-day window before or within 24 hours after chemotherapy. For people exposed to high-dose radiation, two doses are given one week apart, with the first dose given as soon as possible after exposure.
- Neulasta is available as a prefilled syringe for manual injection, a prefilled syringe for use with the on-body injector (OBI), and a vial (used for weight-based dosing in smaller children)
- The Neulasta on-body injector (OBI) is applied to the skin by a healthcare provider and automatically delivers the dose approximately 27 hours later over about 45 minutes
- Dosing for children under 45 kg (about 99 lbs) is based on body weight — only healthcare providers should draw doses from vials for these patients
- Always follow your prescriber's exact dosing schedule; do not adjust the timing on your own
🤒Side effects — in detail▾
The most common side effects reported with pegfilgrastim include:
- Bone pain
- Pain in the arms or legs
- Injection site reactions
- Elevated white blood cell count (leukocytosis)
- Low platelet count (thrombocytopenia)
- Skin rash, hives, or flushing (allergic-type reactions)
More serious reactions — including splenic rupture, acute respiratory distress syndrome (ARDS), severe allergic reactions (anaphylaxis), capillary leak syndrome, and kidney inflammation (glomerulonephritis) — have been reported and require immediate medical attention. If you develop sudden severe left-sided belly or shoulder pain, difficulty breathing, or signs of a severe allergic reaction, seek emergency care right away.
⚠️Warnings & precautions▾
- Splenic rupture: The spleen can enlarge and rupture — which can be fatal. Seek immediate care for sudden left upper belly or shoulder pain.
- Acute respiratory distress syndrome (ARDS): Severe lung failure has occurred. Seek emergency care for new fever, breathing difficulty, or lung symptoms.
- Serious allergic reactions: Anaphylaxis can occur, sometimes days after stopping treatment for the reaction. Pegfilgrastim is contraindicated if you have ever had a serious allergic reaction to pegfilgrastim or filgrastim products.
- Sickle cell crises: Severe and sometimes fatal crises have occurred in patients with sickle cell disease. The drug should be stopped immediately if a crisis occurs.
- Capillary leak syndrome: Fluid can leak from blood vessels, causing low blood pressure and swelling — this can be life-threatening.
- MDS and AML: Myelodysplastic syndrome and acute myeloid leukemia have been reported in breast and lung cancer patients using pegfilgrastim with chemotherapy and/or radiation.
- Kidney inflammation (glomerulonephritis): Monitor for blood in the urine, swelling, or changes in urination.
- Arteritis (blood vessel inflammation): Serious inflammation of large and medium blood vessels, including the aorta, has been reported — sometimes within the first week. Watch for unexplained fever, abdominal, back, or neck pain.
- On-body injector device failure (Neulasta OBI): Missed or partial doses can occur if the device malfunctions. Notify your healthcare provider right away if you think the device did not work correctly.
🔀What it interacts with▾
The FDA label for pegfilgrastim does not describe specific drug-drug interactions. However, there are important clinical considerations your prescriber should know about:
- Chemotherapy timing: pegfilgrastim must not be given in the 14-day window before or within 24 hours after myelosuppressive chemotherapy — giving it too close to chemotherapy can worsen bone marrow effects
- Radiation therapy: use with radiation therapy in breast and lung cancer patients has been associated with an increased risk of MDS and AML (blood cancers) — your doctor will weigh this risk carefully
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use pegfilgrastim if you have ever had a serious allergic reaction (including anaphylaxis) to pegfilgrastim or filgrastim products
- Tell your doctor if you have sickle cell disease — severe and sometimes fatal sickle cell crises have been reported
- Tell your doctor if you are allergic to acrylic adhesives before using the Neulasta on-body injector (OBI)
- Tell your doctor if you are pregnant or trying to become pregnant — there is not enough human data to fully assess risk; animal studies at high doses showed increased pregnancy loss in rabbits
- Tell your doctor if you are breastfeeding — it is not known if pegfilgrastim passes into breast milk
- Pegfilgrastim is approved for use in children from newborns and older; weight-based dosing is used for children under 45 kg
- Older adults (65 and older) have not shown differences in safety or effectiveness in clinical studies, so no dose adjustment is needed based on age alone
- Kidney impairment does not appear to significantly affect how the body handles pegfilgrastim, based on clinical study data
🚑If you take too much▾
Taking too much pegfilgrastim can cause leukocytosis (dangerously high white blood cell counts) and bone pain. One case report noted swelling, shortness of breath, and fluid around the lungs after a patient accidentally received the drug on 8 consecutive days. If an overdose is suspected, the patient should be monitored closely for adverse reactions and medical attention sought. You can also contact Poison Control at 1-800-222-1222 for guidance.
📡Pharmacodynamics — effects in the body▾
Pegfilgrastim raises the body's neutrophil count by stimulating bone marrow cells to produce and release more neutrophils (infection-fighting white blood cells). The longer the body is exposed to pegfilgrastim, the shorter the period of severe neutropenia (dangerously low white blood cell counts) — and this shorter low-point is what makes it effective at preventing serious infections. Dosing regimens are designed with reducing the duration of severe neutropenia as the primary goal.
🔬Pharmacokinetics — how your body processes it▾
After subcutaneous injection, pegfilgrastim is processed by the body in an unusual way: its clearance is directly tied to the number of neutrophils present — as white blood cell counts recover, the body clears the drug more quickly. The half-life (time for the body to clear half the drug) of Neulasta after subcutaneous injection ranges from 15 to 80 hours, with significant variation between individuals. Body weight also plays a role — patients with higher body weight tend to have higher drug exposure when given a weight-adjusted dose. Kidney impairment does not meaningfully affect how the body handles pegfilgrastim.
📦How to store it▾
Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration.
📄 Written from Pegfilgrastim Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Pegfilgrastim Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I need this injection if I'm already getting chemotherapy? ▾
How and where is the injection given? ▾
What side effects are most likely, and which ones should I call my doctor about? ▾
I'm using the Neulasta on-body injector. How do I know it worked? ▾
Is it safe to take this if I'm pregnant or breastfeeding? ▾
Can my child receive this medication? ▾
Is Pegfilgrastim Injection available over the counter? ▾
When was Pegfilgrastim Injection first available? ▾
Who makes Pegfilgrastim Injection? ▾
💬 Answers drafted from Pegfilgrastim Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Pegfilgrastim Injection comes
Pegfilgrastim Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Neulasta is indicated to reduce the risk of febrile neutropenia (fever caused by dangerously low white blood cell counts) in adults and children with non-myeloid cancers receiving myelosuppressive chemotherapy
- Neulasta is indicated to improve survival in adults and children acutely exposed to myelosuppressive doses of radiation
- Fylnetra is indicated for the same conditions as Neulasta, as a biosimilar product
- Fulphila and UDENYCA are biosimilars approved for the same conditions as Neulasta
- Neulasta is given as a subcutaneous (under-the-skin) injection once per chemotherapy cycle; do not give between 14 days before and 24 hours after chemotherapy
- Neulasta is also available with an on-body injector (OBI) — a healthcare provider applies it to intact skin on the abdomen or back of the arm, and the dose is automatically delivered about 27 hours later over approximately 45 minutes
- For the radiation indication, Neulasta is given as two subcutaneous injections, one week apart, starting as soon as possible after radiation exposure
- Allow the prefilled syringe or vial to reach room temperature for at least 30 minutes before use; inspect the solution — do not use if it is discolored or contains particles
📊 Pegfilgrastim Injection across the U.S. market
How Pegfilgrastim Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Pegfilgrastim Injection is used
A general measure of how commonly Pegfilgrastim Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Pegfilgrastim Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Pegfilgrastim Injection prescribed? Of the 1,596 medications we measure, Pegfilgrastim Injection ranks #634 by Medicaid prescriptions — more than 60% of them.
Utilization by Pegfilgrastim Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
0.6 ML pegfilgrastim-jmdb 10 MG/ML Prefilled Syringe Most dispensed
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2048020
0.6 ML pegfilgrastim-cbqv 10 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2102703
0.6 ML pegfilgrastim-apgf 10 MG/ML Prefilled Syringe
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2469335
0.6 ML pegfilgrastim 10 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2549331
0.6 ML pegfilgrastim 10 MG/ML Prefilled Syringe
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 727539
0.6 ML pegfilgrastim-cbqv 10 MG/ML Injection
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2673598
0.6 ML pegfilgrastim-pbbk 10 MG/ML Prefilled Syringe
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2602781
0.6 ML pegfilgrastim-fpgk 10 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2613763
0.6 ML pegfilgrastim-cbqv 10 MG/ML Auto-Injector
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2632544
0.6 ML pegfilgrastim-bmez 10 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2260704
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pegfilgrastim Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 12 of 16 listed Pegfilgrastim Injection NDCs with Medicaid activity.
🔍 Compare Pegfilgrastim Injection products
A representative set of FDA-listed product records for Pegfilgrastim Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 4 mg/0.4 mL | Subcutaneous | Amgen, Inc × 2 listings | BLA | View NDC → |
| 6 mg/0.6 mL | Subcutaneous | Amgen, Inc × 2 listings | BLA | View NDC → |
| 6 mg/0.6 mL | Subcutaneous | Amgen Inc × 2 listings | BLA | View NDC → |
| 6 mg/0.6 mL | Subcutaneous | Amneal Pharmaceuticals LLC × 3 listings | BLA | View NDC → |
| 6 mg/0.6 mL | Subcutaneous | Biocon Biologics Inc. | BLA | View NDC → |
| 6 mg/0.6 mL | Subcutaneous | Mylan Institutional LLC × 2 listings | BLA | View NDC → |
Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Pegfilgrastim Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Pegfilgrastim Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Pegfilgrastim Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Pegfilgrastim Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 338036 3 dose forms · 12 strengths
-
Dose form (SCDF) Auto-Injector RxCUI 2632543In current FDA listingsClinical drug / strength (SCD) 0.6 ML pegfilgrastim-cbqv 10 MG/MLRxCUI 2632544 -
Dose form (SCDF) Injection RxCUI 2549330In current FDA listingsClinical drug / strength (SCD) 0.4 ML pegfilgrastim 10 MG/MLRxCUI 27395030.6 ML pegfilgrastim 10 MG/MLRxCUI 25493310.6 ML pegfilgrastim-cbqv 10 MG/MLRxCUI 2673598 -
Dose form (SCDF) Prefilled Syringe RxCUI 727538No current FDA listingClinical drug / strength (SCD) 0.6 ML pegfilgrastim 10 MG/MLRxCUI 7275390.6 ML pegfilgrastim-apgf 10 MG/MLRxCUI 24693350.6 ML pegfilgrastim-bmez 10 MG/MLRxCUI 22607040.6 ML pegfilgrastim-cbqv 10 MG/MLRxCUI 21027030.6 ML pegfilgrastim-fpgk 10 MG/MLRxCUI 26137630.6 ML pegfilgrastim-jmdb 10 MG/MLRxCUI 20480200.6 ML pegfilgrastim-pbbk 10 MG/MLRxCUI 26027810.6 ML pegfilgrastim-unne 10 MG/MLRxCUI 2737548
Look up RxCUI 338036 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Pegfilgrastim Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Pegfilgrastim Injection belongs to the Leukocyte Growth Factor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Amgen Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.