Drug Database
PE

pegfilgrastim (Peijin / Paijin)

✓ Approved

Xiamen Amoytop Biotech Co.ltd · CSF3R · Recombinant Proteins

What is pegfilgrastim?

pegfilgrastim is a recombinant proteins developed by Xiamen Amoytop Biotech Co.ltd. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesPeijin, Paijin
CompanyXiamen Amoytop Biotech Co.ltd
Drug ClassRecombinant Proteins
Molecular TargetCSF3R
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Xiamen Amoytop Biotech Co.ltd

Mechanism of Action

Molecular Targets

pegfilgrastim acts on 1 molecular target:

CSF3Rcolony stimulating factor 3 receptor (CD114, GCSFR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

pegfilgrastim is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersBone marrow disorder✓ Approved
Blood and lymphatic system disordersNeutropeniaPhase II

Related Research Articles

PubMedQJM : monthly journal of the Association of Physicians2026-05-19

Intravitreal pegfilgrastim for indirect traumatic optic neuropathy: a first-in-human phase 1/2a study.

Huang Chin-Te CT, Wen Yao-Tseng YT, Liu Pei-Kang PK, Tsai Rong-Kung RK

Indirect traumatic optic neuropathy (TON) is associated with severe vision loss and no proven treatment. To evaluate the safety and exploratory functional outcomes of intravitreal pegfilgrastim in patients with indirect TON. Single-center, open-label, single-arm phase 1/2a proof-of-concept study. Twelve adults with acute unilateral indirect TON received a single intravitreal injection of 0.15 mL pegfilgrastim and were followed for 3 months. Outcomes included adverse events, best-corrected visual acuity (BCVA), visual field mean deviation, retinal nerve fiber layer thickness, and flash visual evoked potentials (VEP). No serious ocular or systemic treatment-related adverse events were observed. Transient leukocytosis occurred after treatment and resolved spontaneously. Within-subject improvements in BCVA were observed at 1 week, 1 month, and 3 months (p < 0.05), and visual field mean deviation improved at 3 months (p < 0.05). Retinal nerve fiber layer thickness declined progressively during follow-up. No significant change was detected in VEP latency or amplitude. Intravitreal pegfilgrastim was feasible and well tolerated in this first-in-human study of indirect TON. Exploratory functional improvements were observed in a subset of participants, but controlled studies are required to determine whether these changes exceed the natural history of the disease.

PMID 42155034
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PubMedIn vivo (Athens, Greece)2026-04-29

Risk Factors and Clinical Significance of Grade ≥3 Neutropenia During the First Cycle of Cabazitaxel Therapy With Primary Pegfilgrastim Prophylaxis in Metastatic Castration-resistant Prostate Cancer.

Sato Ryo R, Yoshimi Yukihiro Y, Nishio Tetsuharu T, Matsunaga Y U YU et al.

Cabazitaxel is an established treatment for metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen; however, it is frequently associated with severe neutropenia. Although primary prophylaxis with pegfilgrastim is widely used, severe neutropenia still occurs. The present study aimed to identify risk factors for grade ≥3 neutropenia during the first cabazitaxel cycle (Cycle 1) under universal pegfilgrastim prophylaxis and to evaluate its clinical significance. This retrospective study analyzed 40 patients with mCRPC treated with cabazitaxel at our institution between January 2015 and January 2025. All patients received primary prophylactic pegfilgrastim on day 3 of each cycle. The primary endpoint was the occurrence of grade ≥3 neutropenia during Cycle 1. A logistic regression analysis was performed to identify associated factors. Overall survival (OS) and progression-free survival (PFS) were analyzed using the Kaplan-Meier method and compared using the Log-rank test. Grade ≥3 neutropenia during Cycle 1 occurred in 18 patients (45.0%). A univariate analysis identified age ≥75 years and prior docetaxel exposure ≥9 cycles as significant risk factors for grade ≥3 neutropenia. In a multivariate analysis, prior docetaxel exposure ≥9 cycles was identified as an independent predictor. Febrile neutropenia occurred in six patients (15.0%) during Cycle 1. There were no significant differences in OS or PFS between patients with and without grade ≥3 neutropenia. Despite universal pegfilgrastim prophylaxis, severe neutropenia during the first cabazitaxel cycle remains common, particularly in patients with extensive prior docetaxel exposure. However, early grade ≥3 neutropenia was not associated with poorer survival outcomes. These results suggest that under adequate supportive care, early hematologic toxicity alone does not preclude continued cabazitaxel treatment.

PMID 42049400
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PubMedInternational journal of hematology2026-04-24

Splenic rupture secondary to pegfilgrastim in a healthy allogeneic peripheral blood hematopoietic stem cell donor.

Takahashi Ryo R, Oya Koichi K, Ishizawa Yuki Y, Nagano Yusuke Y et al.

Granulocyte-colony stimulating factor (G-CSF) is widely used to mobilize peripheral blood stem cells (PBSCs) for hematopoietic cell transplantation (HCT). G-CSF is generally well-tolerated but can cause life-threatening complications such as splenic rupture in rare cases. Long-acting pegfilgrastim (Peg-G) is increasingly used for PBSC mobilization, but its risk for splenic rupture is less well characterized. Here, we report a case of splenic rupture secondary to Peg-G administered for PBSC mobilization in a healthy 25-year-old male haploidentical donor. He presented with left upper quadrant abdominal pain shortly after PBSC harvest 5 days following administration of Peg-G. Computed tomography (CT) revealed splenomegaly with rupture, and small bloody peri-splenic and pelvic ascites. He was managed conservatively, but the next evening his symptoms temporarily worsened, prompting a repeat CT scan, which showed no change. Thereafter, the pain did not recur, and the patient was discharged on day 8. One month later, a follow-up CT demonstrated complete resolution. To our knowledge, this is the first case of splenic rupture secondary to Peg-G for PBSC mobilization in a healthy allogeneic donor and highlights the importance of vigilance for this rare complication when G-CSF or Peg-G is used for mobilization.

PMID 42029883
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PubMedNaunyn-Schmiedeberg's archives of pharmacology2026-04-23

Safety assessment of Neulasta® (pegfilgrastim) in patients with solid tumors: a real-world adverse event analysis from the FAERS database.

Lin Keyun K, Chen Shuang S, Huang Shiying S, Jiang Mei M

The study was based on the FDA Adverse Event Reporting System (FAERS) database, with the objective of analysing the actual safety of Neulasta® (pegfilgrastim) in patients with solid tumours. This study also sought to provide a reference for the use of clinical drugs. For patients with solid tumors, data on adverse events (AEs) related to Neulasta® (pegfilgrastim) applications between the first quarter of 2004 and the fourth quarter of 2024 were collected and standardized. Subsequently, an analysis of the signal quantization technique was conducted. The following methods are included: Reporting Odds Ratio (ROR) method, proportional reporting ratio (PRR) method, Bayesian Confidence Propagation Neural Network (BCPNN) method, and Multi-Item Gamma Poisson Shrinker (MGPS) method. A total of 193,534 reports were retrieved, encompassing 6,380 Adverse Drug Event (ADE) reports in patients diagnosed with solid tumors, with Neulasta® (pegfilgrastim) identified as the primary suspected pharmaceutical agent. Following the incorporation of duplicate PRIMARYID, the study comprised a total of 2,428 patients. At the level of system organ classes (SOCs), four SOCs were positive in the four signal quantification techniques, including musculoskeletal and connective tissue disorders, general disorders and administration site conditions, blood and lymphatic system disorders, injury, poisoning, and procedural complications. At the preferred term (PTs) level, 251 PTs were found from 26 SOCs, including febrile neutropenia, leukocytosis, eye swelling, lip swelling, swollen tongue, influenza-like illness, application site hemorrhage, injection site pain, application site pain, swelling face, hypersensitivity, lower respiratory tract infection, wrong technique in product usage process, unintentional medical device removal, accidental exposure to product, device use error, drug dose omission by device, intercepted product preparation error, product preparation error, device placement issue, underdose, abnormal white blood cell count, abnormal neutrophil count, increased white blood cell count, bone pain, myalgia, decreased mobility, pelvic pain, urticaria, and hyperhidrosis. These findings, while hypothesis-generating, require validation through controlled epidemiological studies due to the inherent limitations of spontaneous reporting databases. Neulasta® (pegfilgrastim) is a promising treatment option for patients with solid tumors. This study focused on the population of solid tumors, providing more references and support for the FDA-approved labeling regarding the drug-related adverse reactions of Neulasta® (pegfilgrastim) in the population with solid tumors.

PMID 42024237
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PubMedJACC. Case reports2026-04-07

ST-Segment Elevation Myocardial Infarction After Pegfilgrastim: Case Report and Review of Mechanistic Considerations.

Goetze Collin C, Dreger Henryk H, Chiu Cheng-Ying CY

Granulocyte-colony stimulating factors (G-CSFs) are widely used to prevent chemotherapy-induced neutropenia, but they have been linked to coronary neovascularization and prothrombotic effects. A 62-year-old man with small cell lung cancer developed an acute posterior ST-segment elevation myocardial infarction (STEMI) 1 day after receiving 6 mg of pegfilgrastim during his second chemo-immunotherapy cycle. Coronary angiography revealed an occluded right coronary artery without atherosclerosis. Aspiration thrombectomy significantly reduced thrombus burden, restoring TIMI flow grade 3. Initial blood tests showed leukocytosis (white blood cells: 82.13 × 109/L) and thrombocytosis (platelets: 773 × 109/L), which normalized at discharge. Transesophageal echocardiography excluded embolic sources, and hyperviscosity syndrome was considered. Marked leukocytosis and thrombocytosis after pegfilgrastim plausibly triggered acute myocardial infarction via leukostasis/hyperviscosity, endothelial activation, neutrophil extracellular traps, and platelet reactivity. To our knowledge, this first reported STEMI after pegfilgrastim warrants vigilance for leukocytosis-related thromboembolic complications in oncology patients. G-CSF-induced leukocytosis should be considered as a rare cause of acute myocardial infarction in patients without significant cardiovascular history. Thrombectomy remains a valuable adjunctive tool.

PMID 41945527
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PubMedAnnals of internal medicine2026-03-23

Summary for Patients: Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain.

PMID 41871356
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