Pegfilgrastim

Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

• FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

• FYLNETRA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3) ].contraindicated

Patients with cancer receiving myelosuppressive chemotherapy 6 mg administered subcutaneously once per chemotherapy cycle. (2.1) Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. (2.1) Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. (2.3) Patients acutely exposed to myelosuppressive doses of radiation Two doses, 6 mg each, administered subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after. (2.2) Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. (2.3) 2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy The recommended dosage of FYLNETRA is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administer FYLNETRA between 14 days before and 24 hours after administration of cytotoxic chemotherapy. 2.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome The recommended dose of FYLNETRA is two doses, 6 mg each, administered subcutaneously one week apart. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Administer the second dose one week after the first dose. Obtain a baseline complete blood count (CBC).

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, lung infiltrates, or respiratory distress. Discontinue FYLNETRA in patients with ARDS. (5.2) Serious allergic reactions, including anaphylaxis: Permanently discontinue FYLNETRA in patients with serious allergic reactions. (5.3) Fatal sickle cell crises: Discontinue FYLNETRA if sickle cell crisis occurs. (5.4) Glomerulonephritis: Evaluate and consider dose-reduction or interruption of FYLNETRA if causality is likely. (5.5) Thrombocytopenia: Monitor platelet counts. (5.7) Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using FYLNETRA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. (5.10) 5.1 Splenic Rupture Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving FYLNETRA. 5.2 Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving FYLNETRA, for ARDS. Discontinue FYLNETRA in patients with ARDS.

The following clinically significant 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) ] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions (5.4) ] Glomerulonephritis [see Warnings and Precautions (5.5) ] Leukocytosis [see Warnings and Precautions (5.6) ] Thrombocytopenia [see Warnings and Precautions (5.7) ] Capillary Leak Syndrome [see Warnings and Precautions (5.8) ] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.9) ] Myelodysplastic Syndrome [see Warnings and Precautions (5.10) ] Acute Myeloid Leukemia [see Warnings and Precautions (5.10) ] Aortitis [see Warnings and Precautions (5.11) ] Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835 5472, option 3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of FYLNETRA ® has been demonstrated for the condition(s) of use (e.g.

8.1 Pregnancy Risk Summary Although available data with FYLNETRA or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). In pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population 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% to 4% and 15% to 20%, respectively.

Metabolism

The pharmacokinetics of pegfilgrastim was studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim was nonlinear, and clearance decreased with increases in dose.

Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [ see Adverse Reactions (6) ] .

• Jan 31, 2002BLABLA125031Amgen
• Jun 4, 2018BLABLA761075Mylan Gmbh
• Nov 2, 2018BLABLA761039Coherus Biosciences Inc
• Nov 4, 2019BLABLA761045Sandoz Inc
• Jun 10, 2020BLABLA761111Hospira Inc
• May 26, 2022BLABLA761084Kashiv Biosciences Llc
• Nov 28, 2025BLABLA761212Lupin Ltd

1. 1Device Adhesion Issue11,60212%
2. 2Wrong Technique In Product Usage Process10,25110%
3. 3Unintentional Medical Device Removal8,9859.0%
4. 4Device Malfunction7,5247.5%
5. 5Device Use Error6,0526.1%
6. 6Device Issue5,1595.2%
7. 7Accidental Exposure To Product5,0335.0%
8. 8Off Label Use3,8553.9%
9. 9Febrile Neutropenia3,8033.8%
10. 10Device Occlusion3,3083.3%
11. 11Death3,0773.1%
12. 12Bone Pain2,9833.0%
13. 13Neutropenia2,7142.7%
14. 14Fatigue2,6692.7%
15. 15Pyrexia2,5602.6%

The 10 most recently updated of 426 ClinicalTrials.gov registrations naming Pegfilgrastim as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
  Recruiting · Phase 2 · Phase 3 · Interventional · 131 enrolled · National Cancer Institute (NCI)
  NCT04628767updated 2026-06-11
• Protocol Title: Safety and Feasibility of Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis in Participants With RUNX1 Familial Platelet Disorder
  Recruiting · Phase 1 · Interventional · 4 enrolled · M.D. Anderson Cancer Center
  NCT06414889updated 2026-06-11
• A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
  Recruiting · Phase 3 · Interventional · 590 enrolled · Merck Sharp & Dohme LLC
  NCT07419295updated 2026-06-08
• Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas
  Recruiting · Phase 1 · Interventional · 20 enrolled · City of Hope Medical Center
  NCT07278856updated 2026-06-05
• Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma
  Not yet recruiting · Phase 2 · Interventional · 34 enrolled · Abramson Cancer Center at Penn Medicine
  NCT07059611updated 2026-06-05
• Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
  Active not recruiting · Phase 2 · Interventional · 75 enrolled · National Cancer Institute (NCI)
  NCT00092222updated 2026-06-05
• ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
  Not yet recruiting · Phase 2 · Interventional · 38 enrolled · Michael Spinner, MD
  NCT07021989updated 2026-06-04
• Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
  Active not recruiting · Phase 3 · Interventional · 244 enrolled · National Cancer Institute (NCI)
  NCT04759586updated 2026-06-03
• Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
  Recruiting · Phase 3 · Interventional · 1,042 enrolled · University College, London
  NCT04685616updated 2026-06-02
• Mature B-Cell Lymphoma And Leukemia Study III
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 128 enrolled · St. Jude Children's Research Hospital
  NCT01046825updated 2026-06-02

Frequently asked questions

How does Pegfilgrastim work?

Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

What is Pegfilgrastim used for?

According to FDA labeling, Pegfilgrastim carries indications including: FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pegfilgrastim?

Pegfilgrastim is classified as Colony stimulating factors, Leukocyte Growth Factor, Receptor Activity Modifying Protein Agonists, Increased Granulocytic Cell Production, Increased Myeloid Cell Production.

What are the brand names for Pegfilgrastim?

Pegfilgrastim is marketed under brand names including Armlupeg, Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo.

What are the contraindications for Pegfilgrastim?

Pegfilgrastim labeling lists contraindications including: FYLNETRA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3) ].. Always consult the full prescribing information and a clinician.