# Pegfilgrastim

Source: https://onco.cc/drugs/pegfilgrastim/  
OnCo record `pegfilgrastim` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Pegfilgrastim (Neulasta) is a long-acting form of the growth factor G-CSF, given once per chemotherapy cycle to speed white cell recovery and prevent febrile neutropenia; one dose replaces about eleven daily filgrastim injections. Biosimilars have been sold since 2018 and the Onpro on-body injector delivers it automatically the day after chemotherapy; bone pain is the main side effect.

## Summary

Pegfilgrastim was approved by the FDA in January 2002 to decrease the incidence of infection manifested by febrile neutropenia in non-myeloid malignancies receiving myelosuppressive chemotherapy, on randomised trials showing a single 6 mg dose per cycle equivalent to about 11 daily filgrastim injections; the EU authorised Neulasta in August 2002 and an acute radiation syndrome indication was added in the US in 2015. It became one of the highest-selling cancer drugs before biosimilars arrived (Fulphila and Udenyca in 2018, Ziextenzo, Nyvepria, Fylnetra, Stimufend and others since), and the Onpro on-body injector avoids a next-day clinic visit. It is not indicated for stem cell mobilisation. Bone pain is the main adverse effect; splenic rupture, capillary leak, aortitis and glomerulonephritis are rare.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Also known as: Fulphila (pegfilgrastim-jmdb); Udenyca (pegfilgrastim-cbqv); Ziextenzo (pegfilgrastim-bmez); Nyvepria (pegfilgrastim-apgf); Fylnetra; Stimufend; Undencyca; Neulasta Onpro on-body injector
- Tags: nci-list; supportive
- Brand: Neulasta
- Modality: Pegylated recombinant granulocyte colony-stimulating factor
- Mechanism: Filgrastim with a 20 kDa polyethylene glycol chain that abolishes renal clearance so that elimination depends on neutrophil-mediated uptake; levels fall as neutrophils recover, giving self-regulating once-per-cycle dosing.
- Approvals: US 2002: Decrease in febrile neutropenia in non-myeloid malignancies on myelosuppressive chemotherapy (acute radiation syndrome added 2015); US 2018: First biosimilars (Fulphila, Udenyca); further biosimilars 2019 onwards; EU 2002: Reduction in duration of neutropenia and febrile neutropenia after cytotoxic chemotherapy (Neulasta); biosimilars from 2018

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Pegfilgrastim
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=pegfilgrastim
- NCI drug page: https://www.cancer.gov/about-cancer/treatment/drugs/pegfilgrastim
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta

## Connected records

- drugs: [Efbemalenograstim alfa](https://onco.cc/drugs/efbemalenograstim-alfa/), [Eflapegrastim](https://onco.cc/drugs/eflapegrastim/), [Filgrastim (G-CSF)](https://onco.cc/drugs/filgrastim/), [Lenograstim](https://onco.cc/drugs/lenograstim/), [Lipegfilgrastim](https://onco.cc/drugs/lipegfilgrastim/)
- technologies: [Biosimilar manufacturing and comparability](https://onco.cc/technologies/biosimilar-manufacturing/), [Growth factors: G-CSF and febrile neutropenia prevention](https://onco.cc/technologies/g-csf-growth-factors/)
- companies: [Amgen](https://onco.cc/companies/amgen/), [Eurofarma](https://onco.cc/companies/eurofarma/), [Sandoz](https://onco.cc/companies/sandoz/), [TORL BioTherapeutics](https://onco.cc/companies/torl-biotherapeutics/), [Viatris](https://onco.cc/companies/viatris/)
- trials: [ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer](https://onco.cc/trials/nct00261313/), [CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.](https://onco.cc/trials/nct06690775/), [Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer](https://onco.cc/trials/nct00077311/), [NeoPACT](https://onco.cc/trials/neopact/), [Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy](https://onco.cc/trials/nct03252431/), [Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma](https://onco.cc/trials/nct06220032/), [Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer](https://onco.cc/trials/nct06616987/), [Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer](https://onco.cc/trials/nct00431080/), [REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1](https://onco.cc/trials/nct05870748/), [Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer](https://onco.cc/trials/nct01985724/), [Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer](https://onco.cc/trials/nct00615602/), [Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies](https://onco.cc/trials/nct07064018/), [XM22-03](https://onco.cc/trials/xm22-03/)
- terms: [Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination](https://onco.cc/terms/lymphoma-tx-pjp-and-infection-prophylaxis/)
- targets: [G-CSF receptor (CSF3R)](https://onco.cc/targets/csf3r/)
- key papers: [Efficacy and safety of lipegfilgrastim versus pegfilgrastim in breast cancer patients receiving doxorubicin and docetaxel (XM22-03)](https://onco.cc/key-papers/paper-xm22-03-bondarenko-bmc-cancer-2013/)

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