Pegfilgrastim

Pronunciation: peg-fil-GRAS-tim.

Generic name
pegfilgrastim
Drug class
Granulocyte colony-stimulating factor (G-CSF) analogue -- a pegylated (long-acting), recombinant human leukocyte growth factor
Form
Solution for injection, pre-filled syringe (including on-body injector devices in some markets), 6 mg/0.6 mL
Route
Subcutaneous injection
Legal status
Prescription-only, clinician-administered or clinician-directed in all markets reviewed

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Ziextenzo, Pelgraz, Filpegla (biosimilars) (5) · Full directory

What pegfilgrastim is and how it works

Pegfilgrastim is a long-acting, laboratory-made version of a protein your body naturally produces (granulocyte colony-stimulating factor, or G-CSF) that stimulates the bone marrow to produce more white blood cells (neutrophils). It is given as a single injection under the skin, once per chemotherapy cycle, to help reduce the risk of infection from low white blood cell counts (neutropenia) after certain cancer chemotherapy. (1) (2)

Pegfilgrastim does not carry a formal boxed warning -- confirmed directly from the current US label, not assumed -- but it does carry several real, serious risks that your care team will discuss with you and watch for: a rare but serious risk of spleen rupture, a rare lung condition called acute respiratory distress syndrome (ARDS), serious allergic reactions, and other less common but serious effects. Because of this, you will be told what warning signs to watch for (such as pain in your upper left abdomen or shoulder, or new breathing difficulty) and to contact your care team promptly if they occur.

Mechanism of action: how pegfilgrastim works

Pegfilgrastim is filgrastim (recombinant human G-CSF) conjugated to a polyethylene glycol (PEG) molecule, which reduces renal clearance and extends its half-life, allowing a single injection to cover an entire chemotherapy cycle rather than requiring daily injections (as with unmodified filgrastim). It binds G-CSF receptors on neutrophil precursors, stimulating their proliferation and differentiation. (1) (2)

What pegfilgrastim is used for

Reducing the risk of infection (febrile neutropenia) after chemotherapy

Used to reduce the duration of neutropenia (low white blood cell count) and the incidence of febrile neutropenia (fever with low white blood cell count) in patients receiving myelosuppressive chemotherapy for non-myeloid cancers. (1) (2)

Acute radiation syndrome

Used to increase survival in adults and children acutely exposed to myelosuppressive doses of radiation (acute radiation syndrome) -- confirmed as an indication in the US source reviewed. (1)

Before taking pegfilgrastim

Do not take / not appropriate for

  • Do not receive pegfilgrastim if you have a history of a serious allergic reaction (including anaphylaxis) to pegfilgrastim or to filgrastim. (all countries) (1) (2)

Tell your clinician about

  • Any history of sickle cell disorder -- severe and sometimes fatal sickle cell crises have occurred with this medicine.
  • Any history of spleen problems or an enlarged spleen.
  • Any history of kidney problems.
  • Any lung problems, including a history of pneumonia or ARDS.
  • Whether you are pregnant, plan to become pregnant, or are breastfeeding.
  • Any known allergy to latex, since some delivery devices contain latex-derived components (check your specific product's information).
(1) (2)

How to take pegfilgrastim

  • Given as a single injection under the skin (subcutaneously), usually into the abdomen, thigh, or upper arm, once per chemotherapy cycle.
  • Must be given at least 24 hours after your chemotherapy dose, and not in the 14 days before your next chemotherapy dose -- your care team will time this precisely.
  • May be given by a healthcare professional, or, in some markets and situations, self-administered or given by a caregiver at home using a pre-filled syringe or on-body injector device -- always exactly as your care team trains and directs.
  • Do not change the timing or skip this injection on your own without checking with your care team, since correct timing relative to chemotherapy affects both safety and effectiveness.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Because pegfilgrastim is timed precisely relative to your chemotherapy cycle, contact your care team promptly if a dose is missed or its timing is in question -- do not decide on your own whether or when to give a missed dose.

Overdose

Seek prompt advice from your care team if you think an incorrect dose was given or self-administered. Report any new or worsening symptoms, particularly bone pain, to your care team. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Bone pain.

What to notice: Bone pain.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Pain in the arms or legs.

What to notice: Pain in the arms or legs.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Injection-site reactions.

What to notice: Injection-site reactions.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of spleen enlargement or rupture — serious

Symptoms: Pain in the upper left abdomen or the tip of the left shoulder.

Action: Contact your care team promptly, or seek emergency help for severe or sudden pain -- splenic rupture, including fatal cases, has occurred following pegfilgrastim administration. There is no formal boxed warning for this medicine, but this is a real and serious risk your care team monitors for. (1) (2)

Signs of acute respiratory distress syndrome (ARDS) — serious

Symptoms: Fever, cough, difficulty breathing, or rapid breathing.

Action: Contact your care team promptly or seek emergency help -- ARDS can occur after pegfilgrastim; treatment is generally stopped if this develops, and it is managed as a medical emergency. (1) (2)

Signs of a serious allergic reaction (anaphylaxis) — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives; dizziness or fainting.

Action: Seek emergency medical help immediately. This can occur on the first or a later dose; pegfilgrastim is permanently stopped if this occurs. (1) (2)

Sickle cell crisis (in patients with sickle cell disorders) — serious

Symptoms: Severe pain, especially in the chest, back, or joints, in a person with a known sickle cell disorder.

Action: Seek prompt medical attention -- severe and sometimes fatal sickle cell crises have occurred with pegfilgrastim in patients with sickle cell disorders; tell your care team about this condition before starting treatment. (1)

Signs of capillary leak syndrome, kidney inflammation (glomerulonephritis), or blood vessel inflammation (aortitis) — serious

Symptoms: Sudden swelling, low blood pressure, reduced urination, blood in the urine, or fever with back/flank pain.

Action: Contact your care team promptly -- these are rarer but real, documented reactions that have been reported with pegfilgrastim. (1) (2)

Interactions

  • Cytotoxic chemotherapy: pegfilgrastim must be given at least 24 hours after chemotherapy and not within 14 days before the next chemotherapy dose, since giving it too close to chemotherapy can worsen its effects on rapidly dividing bone marrow cells. (1) (2)
  • Certain antimetabolite chemotherapy agents: concomitant use may potentiate myelosuppression, per the UK source reviewed. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Available data from published studies in pregnant women exposed to filgrastim products (a related G-CSF) have not established an association with major birth defects or adverse pregnancy outcomes, per the US source reviewed; animal studies showed no reproductive toxicity at 10 times the recommended human dose. The UK source reviewed states use is not recommended during pregnancy. Discuss with your care team. (1) (2) (3) (4) (5) (6)

Breastfeeding

There are no data on the presence of pegfilgrastim in human breast milk. Related filgrastim products are poorly secreted into breast milk and not orally absorbed by neonates, per the US source reviewed. The UK source reviewed states a decision must be made to discontinue either breastfeeding or pegfilgrastim treatment. Discuss with your care team. (1) (2) (3) (4) (5) (6)

Children

Used in children with weight-based dosing for those under 45 kg, per the US source reviewed. The New Zealand source reviewed (for the Ziextenzo biosimilar) states safety and efficacy in children under 18 have not been established -- follow local specialist guidance for a child. (1) (2) (3) (4) (5) (6)

Elderly

No specific age-based dose adjustment beyond standard weight-based dosing is described in the sources reviewed. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Not specifically addressed with a distinct dose adjustment in the sources reviewed. (1) (2) (3) (4) (5) (6)

Renal_impairment

Not specifically addressed with a distinct dose adjustment in the sources reviewed, though glomerulonephritis (kidney inflammation) is a documented rare adverse reaction requiring monitoring. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-NEULASTA-2026,UK-EMC-NEULASTA-2026,NZ-MEDSAFE-PEGFILGRASTIM-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Assessment for sickle cell disorder
  • Baseline spleen size assessment if clinically indicated
  • Baseline kidney function where relevant

During treatment

  • Monitoring for symptoms of splenic enlargement/rupture (upper left abdominal or shoulder pain).
  • Monitoring for respiratory symptoms suggestive of ARDS (fever, cough, breathing difficulty).
  • Monitoring for signs of allergic reaction, especially around the time of dosing.
  • White blood cell count monitoring, since leukocytosis (very high white cell counts) has been observed.
  • Monitoring for signs of capillary leak syndrome, kidney inflammation, or vasculitis if symptoms suggest them.
(1) (2)

Storage

Store in the refrigerator (typically 2-8degC), protected from light, in the original carton; allow to reach room temperature before injection per your product's specific instructions; do not freeze, and discard if accidentally frozen. Follow your dispensed product's own storage leaflet exactly.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and the UK emc SmPC reviewed for this dossier; verify against the current full label before prescribing.

United States

Indication: Febrile neutropenia risk reduction; acute radiation syndrome

Dose summary: 6 mg subcutaneously once per chemotherapy cycle (patients >=45 kg); weight-based dosing under 45 kg. Acute radiation syndrome: two 6 mg doses one week apart. Not within 14 days before or 24 hours after chemotherapy.

Renal context: No specific renal dose adjustment described in the source reviewed. (1)

United Kingdom / European Union

Indication: Reduction of neutropenia duration and febrile neutropenia incidence

Dose summary: One 6 mg dose subcutaneously per chemotherapy cycle, at least 24 hours after cytotoxic chemotherapy.

Renal context: No specific renal dose adjustment described in the source reviewed. (2)

Mechanism of action

Hepatic guidance

No specific hepatic-impairment dose adjustment was identified in the sources reviewed for this dossier.

Overdose note

No specific antidote; manage supportively and monitor white blood cell counts and for bone pain; discuss any concern promptly with the treating team. (1) (2)

Frequently asked questions

Is pegfilgrastim (Neulasta) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, though the exact brand varies by market and has genuinely changed over time in some places. The Neulasta originator brand is confirmed authorised in the United States, United Kingdom, the European Union (centrally, by the EMA), and Canada. In Australia, the Neulasta originator brand was cancelled by its sponsor in 2024, and pegfilgrastim is now available there via TGA-assessed biosimilars (Ziextenzo, Pelgraz, Filpegla). In New Zealand, this review found current Medsafe data sheets only for the biosimilars Pelgraz and Ziextenzo. (1) (2) (3) (4) (5) (6)

Does pegfilgrastim have a boxed warning?

No. A direct review of the current US FDA label confirms pegfilgrastim does not carry a formal boxed warning. It does carry several real, serious warnings -- splenic rupture (including fatal cases), acute respiratory distress syndrome (ARDS), serious allergic reactions, sickle cell crises in people with sickle cell disorders, capillary leak syndrome, glomerulonephritis, and aortitis -- which are documented on this page with full prominence, but none of these currently rises to formal US boxed-warning level. Health Canada's product monograph does present splenic rupture within a 'Serious Warnings and Precautions' box, which is a Canadian labelling-format convention rather than the same thing as a US boxed warning. (1) (4)

Why does the timing of this injection relative to my chemotherapy matter so much?

Pegfilgrastim must be given at least 24 hours after your chemotherapy dose and not within 14 days before your next chemotherapy dose. Giving it too close to chemotherapy can worsen the effect of the chemotherapy on your rapidly dividing bone marrow cells, which is the opposite of what this medicine is meant to help prevent. Your care team manages this timing precisely. (1) (2)

Is Neulasta the same as its biosimilars?

Biosimilars (such as Ziextenzo, Pelgraz, Filpegla, Fulphila, Lapelga, Nyvepria, and Cegfila, depending on the market) are separately approved medicines that regulators have assessed as highly similar to Neulasta, providing the same health outcomes and comparable safety and effectiveness. They are not automatically identical formulations, and your care team or pharmacist can tell you which specific product you have been prescribed. (5) (3)

What is the mechanism of action of pegfilgrastim?

Pegfilgrastim is filgrastim (recombinant human G-CSF) conjugated to a polyethylene glycol (PEG) molecule, which reduces renal clearance and extends its half-life, allowing a single injection to cover an entire chemotherapy cycle rather than requiring daily injections (as with unmodified filgrastim). It binds G-CSF receptors on neutrophil precursors, stimulating their proliferation and differentiation. (1) (2)

What is the generic name of Pegfilgrastim?

The generic name is pegfilgrastim. (1) (2)

What class of drug is pegfilgrastim?

Pegfilgrastim is classed as: Granulocyte colony-stimulating factor (G-CSF) analogue -- a pegylated (long-acting), recombinant human leukocyte growth factor. (1) (2)

References

  1. NEULASTA (pegfilgrastim) injection, for subcutaneous use -- full prescribing informationDailyMed (U.S. National Library of Medicine) -- FDA-approved drug labeling · United States · accessed 2026-07-30 · source 1
  2. Neulasta Pre-Filled Syringe -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Amgen Limited · United Kingdom · accessed 2026-07-30 · source 2
  3. Neulasta (pegfilgrastim) -- EPAR, centrally authorised medicineEuropean Medicines Agency (EMA) -- European Public Assessment Report (EPAR) · European Union · accessed 2026-07-30 · source 3
  4. NEULASTA (pegfilgrastim) Product Monograph (Amgen Canada); Fulphila (pegfilgrastim) Product Monograph (biosimilar, BGP Pharma ULC)Health Canada -- Product Monograph · Canada · accessed 2026-07-30 · source 4
  5. NEULASTA (Amgen Australia, ARTG 82873) -- sponsor cancellation effective 28 June 2024; Ziextenzo, Pelgraz, and Filpegla -- TGA biosimilar assessmentsTherapeutic Goods Administration (TGA), Australia -- ARTG cancellation notice and AusPAR/AusPMD biosimilar assessments · Australia · accessed 2026-07-30 · source 5
  6. Pelgraz and Ziextenzo (pegfilgrastim biosimilars) -- New Zealand Data SheetsMedsafe (New Zealand regulator) -- New Zealand Data Sheets · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient pegfilgrastim names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • UDENYCA6 mg/.6mL · accord biopharma, inc.
  • STIMUFEND6 mg/.6mL · northstar rx llc
  • Neulasta4 mg/.4mL, 6 mg/.6mL · amgen, inc
  • NYVEPRIA6 mg/.6mL · pfizer laboratories div pfizer inc
  • ZIEXTENZO6 mg/.6mL · sandoz inc
  • FYLNETRA6 mg/.6mL · amneal pharmaceuticals llc
  • ARMLUPEG6 mg/.6mL · lupin pharmaceuticals, inc.
  • Fulphila6 mg/.6mL · biocon biologics inc.

United Kingdom

  • Neulasta (2)MHRA licensed emc smpc confirmed · 6 mg/0.6 mL · Amgen Limited (PLGB 13832/0033)

Canada

  • NEULASTA

Australia

  • Ziextenzo, Pelgraz, Filpegla (biosimilars) (5)TGA assessed biosimilar confirmed · 6 mg/0.6 mL · Sandoz Pty Ltd and others

New Zealand

  • Pelgraz, Ziextenzo (biosimilars) (6)Medsafe registered confirmed · 6 mg/0.6 mL · per Medsafe data sheets
View brands in additional countries.

European Union

Neulasta (3)

This page provides general reference information about pegfilgrastim and is not a substitute for advice from the oncology or clinical team managing your treatment. All dosing and treatment decisions, including timing relative to chemotherapy, should be made with your treating team.

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