{"entity":{"id":"pegfilgrastim","kind":"drug","name":"Pegfilgrastim","aka":["Fulphila (pegfilgrastim-jmdb)","Udenyca (pegfilgrastim-cbqv)","Ziextenzo (pegfilgrastim-bmez)","Nyvepria (pegfilgrastim-apgf)","Fylnetra","Stimufend","Undencyca","Neulasta Onpro on-body injector"],"tldr":"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.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Pegfilgrastim","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=pegfilgrastim"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/pegfilgrastim"},{"label":"EPAR","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta"}],"tags":["nci-list","supportive"],"related":["filgrastim"],"cancers":[],"sections":[],"technologies":["g-csf-growth-factors"],"targets":[],"drugs":[],"companies":["amgen","sandoz","eurofarma"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06690775"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Neulasta","modality":"Pegylated recombinant granulocyte colony-stimulating factor","supportive":true,"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":[{"region":"US","year":2002,"indication":"Decrease in febrile neutropenia in non-myeloid malignancies on myelosuppressive chemotherapy (acute radiation syndrome added 2015)"},{"region":"US","year":2018,"indication":"First biosimilars (Fulphila, Udenyca); further biosimilars 2019 onwards"},{"region":"EU","year":2002,"indication":"Reduction in duration of neutropenia and febrile neutropenia after cytotoxic chemotherapy (Neulasta); biosimilars from 2018"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/pegfilgrastim/","neighbours":{"drug":[{"id":"efbemalenograstim-alfa","kind":"drug","name":"Efbemalenograstim alfa","route":"/drugs/efbemalenograstim-alfa/"},{"id":"eflapegrastim","kind":"drug","name":"Eflapegrastim","route":"/drugs/eflapegrastim/"},{"id":"filgrastim","kind":"drug","name":"Filgrastim (G-CSF)","route":"/drugs/filgrastim/"},{"id":"lenograstim","kind":"drug","name":"Lenograstim","route":"/drugs/lenograstim/"},{"id":"lipegfilgrastim","kind":"drug","name":"Lipegfilgrastim","route":"/drugs/lipegfilgrastim/"}],"technology":[{"id":"biosimilar-manufacturing","kind":"technology","name":"Biosimilar manufacturing and comparability","route":"/technologies/biosimilar-manufacturing/"},{"id":"g-csf-growth-factors","kind":"technology","name":"Growth factors: G-CSF and febrile neutropenia prevention","route":"/technologies/g-csf-growth-factors/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"},{"id":"eurofarma","kind":"company","name":"Eurofarma","route":"/companies/eurofarma/"},{"id":"sandoz","kind":"company","name":"Sandoz","route":"/companies/sandoz/"},{"id":"torl-biotherapeutics","kind":"company","name":"TORL BioTherapeutics","route":"/companies/torl-biotherapeutics/"},{"id":"viatris","kind":"company","name":"Viatris","route":"/companies/viatris/"}],"trial":[{"id":"nct00261313","kind":"trial","name":"ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer","route":"/trials/nct00261313/"},{"id":"nct06690775","kind":"trial","name":"CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.","route":"/trials/nct06690775/"},{"id":"nct00077311","kind":"trial","name":"Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer","route":"/trials/nct00077311/"},{"id":"neopact","kind":"trial","name":"NeoPACT","route":"/trials/neopact/"},{"id":"nct03252431","kind":"trial","name":"Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy","route":"/trials/nct03252431/"},{"id":"nct06220032","kind":"trial","name":"Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma","route":"/trials/nct06220032/"},{"id":"nct06616987","kind":"trial","name":"Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer","route":"/trials/nct06616987/"},{"id":"nct00431080","kind":"trial","name":"Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer","route":"/trials/nct00431080/"},{"id":"nct05870748","kind":"trial","name":"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","route":"/trials/nct05870748/"},{"id":"nct01985724","kind":"trial","name":"Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer","route":"/trials/nct01985724/"},{"id":"nct00615602","kind":"trial","name":"Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer","route":"/trials/nct00615602/"},{"id":"nct07064018","kind":"trial","name":"Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies","route":"/trials/nct07064018/"},{"id":"xm22-03","kind":"trial","name":"XM22-03","route":"/trials/xm22-03/"}],"term":[{"id":"lymphoma-tx-pjp-and-infection-prophylaxis","kind":"term","name":"Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination","route":"/terms/lymphoma-tx-pjp-and-infection-prophylaxis/"}],"target":[{"id":"csf3r","kind":"target","name":"G-CSF receptor (CSF3R)","route":"/targets/csf3r/"}],"paper":[{"id":"paper-xm22-03-bondarenko-bmc-cancer-2013","kind":"paper","name":"Efficacy and safety of lipegfilgrastim versus pegfilgrastim in breast cancer patients receiving doxorubicin and docetaxel (XM22-03)","route":"/key-papers/paper-xm22-03-bondarenko-bmc-cancer-2013/"}]}}