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filgrastim (Grastofil)

✓ Approved

Apobiologix · CSF3R · Recombinant Proteins

What is filgrastim?

filgrastim is a recombinant proteins developed by Apobiologix. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesGrastofil
CompanyApobiologix
Drug ClassRecombinant Proteins
Molecular TargetCSF3R
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Apobiologix

Mechanism of Action

Molecular Targets

filgrastim 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

filgrastim is developed for 3 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersNeutropenia✓ Approved
Surgical and medical proceduresHaematopoietic stem cell mobilisation✓ Approved
Blood and lymphatic system disordersBone marrow disorder✓ Approved

Related Research Articles

PubMedBlood cancer journal2026-11-05

Impact of granulocyte colony-stimulating factors on cytokine release syndrome during bispecific antibody initiation in relapsed/refractory multiple myeloma.

Wang Alice X AX, Shekarkhand Tala T, Nemirovsky David D, Derkach Andriy A et al.

Bispecific antibody (BsAb) treatment in multiple myeloma can be associated with adverse events including cytokine release syndrome (CRS), cytopenias, and infections. While granulocyte colony-stimulating factors (G-CSF) can be used to treat neutropenia, little is known about their safety during the BsAb initiation period and whether G-CSF can increase the risk of CRS. To assess the impact of G-CSF on risk of CRS, we included all patients with multiple myeloma who received at least one dose (step-up doses [SUD] and first treatment dose [FTD]), of commercial teclistamab, elranatamab, or talquetamab between November 2022 and April 2024 at Memorial Sloan Kettering Cancer Center (N = 186). Exposure to G-CSF was defined as administration of at least one dose of filgrastim from 48 h before up to 7 days after BsAb SUD or FTD, or one dose of peg-filgrastim between 7 days prior to up to 7 days after BsAb SUD or FTD. Of the 186 patients, 22 were classified as G-CSF exposed. CRS occurred in 16/22 (73%) patients with G-CSF exposure vs 76/164 (46%) of non-exposed. All CRS was grade 1 (56%) or grade 2 (44%) and the majority occurred prior to G-CSF was given (16/22 patients). The median absolute neutrophil count (ANC) at time of G-CSF exposure was 0.5 × 109/L (0.4-0.7). There was a trend towards increased risk of CRS after G-CSF exposure, although not significant (hazard ratio [HR] 1.7, 95% confidence interval [CI] 0.6-4.7, p = 0.3). These results suggest that G-CSF administration can be considered for neutropenia during BsAb initiation.

PMID 42982775
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PubMedGeneral dentistry2026-10-28

Acute methotrexate toxicity with severe oral ulcerations following inadvertent ingestion: a case report.

Alias Ankitha Miriya AM, Srikantannair Sreela Leela SL, SivaPrasad Twinkle T, Mathew Philips P et al.

Inadvertent ingestion of high-risk medications such as methotrexate may lead to serious and potentially fatal complications. This case report describes the oral manifestations observed in a 68-year-old woman who developed acute methotrexate toxicity after inadvertent ingestion of the drug. The patient presented with oral erosions resembling erythema multiforme along with blistering skin lesions that developed over a 2-week period. She was undergoing treatment with hydroxychloroquine, deflazacort, and mirtazapine for inflammatory arthritis. When she presented for evaluation of the mucocutaneous lesions, it was discovered that she had been taking methotrexate (7.5 mg) instead of the prescribed mirtazapine (7.5 mg) for approximately 1 month due to a dispensing error at a local pharmacy. Laboratory investigations revealed bicytopenia involving leukocytes and erythrocytes, likely attributable to acute methotrexate toxicity. Methotrexate was discontinued, and the patient received intravenous folinic acid, benzydamine mouthwash, triamcinolone oral paste, oral antihistamines, and subcutaneous filgrastim. The mucocutaneous lesions resolved, leukocyte counts improved, hemoglobin remained stable at 11.0 g/dL, and the patient was subsequently discharged. This incident draws attention to the critical need for clinicians to remain alert to potential medication errors when erythema multiforme--like lesions are observed in the oral cavity.

PMID 42949941
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PubMedTransfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie2026-10-09

The Induction Regimen Does Not Affect Stem-Cell Collection in Adult Patients with Ewing Sarcoma.

Scheuble Anne-Marie AM, Heyn Simone S, Bach Enrica E, Pohl Clara C et al.

Ewing sarcoma (ES) is one of the most frequent sarcomas in children and young adults. Dose-intensified induction with vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide (VDC/IE) proved to be more efficient than vincristine, ifosfamide, doxorubicin and etoposide (VIDE) and has emerged as a new standard. Here, we analyzed peripheral blood (pB) and stem-cell yields of adult patients after the induction with VDC/IE and compared them with historic control after VIDE induction. Stem-cell collections of 6 adult ES patients (all male) after VDC/IE were analyzed. Stimulation with filgrastim 5 µg/kg bid was applied in all patients. All patients underwent stem-cell collection with a single apheresis without the use of plerixafor. Collections were performed after 2 (n = 2), 3 (n = 1), and 4 (n = 3) courses of induction chemotherapy. Median CD34+ in pB (/µL) was 176.3 compared to 68.3 in the historic cohort (p = 0.26). The median yields of CD34+, CD3+, and CD56+ (106 cells/kg body weight) in the actual and in the historic cohorts did not differ. No difference regarding the collection efficiency nor vitality 24 h after thawing of the cryoconserved products were noticed. Intensification of induction does not seem to affect the feasibility of stem-cell mobilization and the collection or graft composition in adult patients with ES. Confirmation of our findings in larger cohorts is warranted.

PMID 42851975
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PubMedResearch in heart yield and translational medicine2026-10-08

Agranulocytosis after High Cumulative Doses of Ceftriaxone in Infective Endocarditis: A Rare but Serious Adverse Reaction.

Baicha Amal A, Aboubakr Khaoula K, Driouach Salma S, Mouine Najat N et al.

Ceftriaxone-induced agranulocytosis is rare but can occur after high cumulative doses (≥60 g) or prolonged therapy.Routine CBC monitoring is essential during long-term ceftriaxone treatment, especially in infective endocarditis.Prompt drug withdrawal, antibiotic switch, and rhG-CSF (filgrastim) administration lead to rapid neutrophil recovery.The Naranjo adverse drug reaction probability scale is a useful tool for causality assessment in antibiotic-induced agranulocytosis. Agranulocytosis is a serious, life-threatening condition characterized by a severe reduction in the number of peripheral neutrophils (<0.5 × 109/L). It is most commonly caused by chemotherapy drugs but can be induced by antibiotics. Ceftriaxone is a widely used and generally safe third generation antibiotic for conditions such as infective endocarditis. Ceftriaxone induced agranulocytosis is an extremely rare adverse reaction. Evidence suggests that this adverse reaction is dose dependent and typically occurs following prolonged courses or high cumulative doses of the antibiotic. Despite improvements in management that reduce the mortality rate to approximately 5%, prompt recognition and treatment remain vital. A 56-year-old man diagnosed with native valve infective endocarditis (Streptococcus mitis) was treated with 2 g/day of intravenous ceftriaxone. In the fifth week of treatment, after receiving a cumulative dose of 60 g, the patient developed severe agranulocytosis, reaching a neutrophil nadir of 0.1 × 109/L. Ceftriaxone was promptly stopped and replaced with teicoplanin, and the patient received filgrastim (recombinant human granulocyte colony stimulating factor [rhG CSF]). The case was classified as a probable adverse drug reaction (Naranjo score, 6). Neutrophil recovery was complete by the seventh day, and the patient successfully underwent double valve replacement surgery. Ceftriaxone induced agranulocytosis, albeit rare, is a potentially fatal complication of prolonged therapy. Regular complete blood count monitoring and prompt management-based on drug withdrawal, appropriate antimicrobial coverage, and rhG CSF administration-are essential for favorable outcomes.

PMID 42847030
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PubMedEuropean journal of cancer (Oxford, England : 1990)2026-09-25

Prophylactic use of G-CSFs to reduce neutropenia rates in patients treated with antibody-drug conjugates: A literature review.

Scotté Florian F, Lustberg Maryam M, Aapro Matti M, Ben Abid Fatma F et al.

Although multiple antibody-drug conjugates (ADCs) have demonstrated sufficient efficacy and safety to warrant their approval, many patients require supportive treatment to reduce the severity of ADC-associated toxicities. Clinical guidelines recommend the use of granulocyte colony-stimulating factors (G‑CSFs), such as filgrastim, lenograstim, and long-acting pegfilgrastim, to reduce the duration and severity of chemotherapy-induced neutropenia and the risk of febrile neutropenia (FN). The objective of this literature review was to summarize the available data on the use of G-CSFs in patients treated with ADCs as a strategy to mitigate the risk of severe neutropenia and FN. The identified literature highlight the importance of prophylactic G-CSF use to reduce the occurrence of FN and severe neutropenia in patients treated with ADCs. Although data evaluating the effect of G-CSF use as secondary prophylaxis are limited, available studies highlight the clinical necessity of mitigating neutropenia risk associated with ADCs.

PMID 42790204
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PubMedJournal of orthopaedic science : official journal of the Japanese Orthopaedic Association2026-09-17

Efficacy of prophylactic pegfilgrastim compared with therapeutic filgrastim for preventing febrile neutropenia during chemotherapy for musculoskeletal tumors: A single-center retrospective study.

Tanaka Takaaki T, Nakajima Hideaki H, Imura Yoshinori Y, Wakamatsu Toru T et al.

Febrile neutropenia (FN) is a serious adverse event of chemotherapy that can lead to treatment delays, dose reductions, and life-threatening infections. Prophylactic pegylated granulocyte colony-stimulating factor (peg G-CSF; pegfilgrastim) is recommended to reduce FN risk; however, evidence in patients with musculoskeletal tumors receiving diverse chemotherapy regimens remains limited. We retrospectively reviewed 20 patients (104 chemotherapy administrations) with musculoskeletal tumors treated at a single institution between May 2014 and April 2017. Each patient had received at least one cycle of the same regimen with therapeutic filgrastim prior to switching to prophylactic pegfilgrastim, allowing a within-patient comparison. FN incidence and grade 3/4 neutropenia incidence were compared between the filgrastim group (53 administrations) and the pegfilgrastim group (51 administrations) using Fisher's exact test. FN incidence was significantly lower in the pegfilgrastim group (7.8% vs. 26.4%; odds ratio 0.24, 95% CI 0.07-0.78; P = 0.018), as was grade 3/4 neutropenia (60.8% vs. 100%; P < 0.001). In subgroup analyses by regimen, FN was numerically reduced across all regimens but did not reach statistical significance in any individual subgroup, likely owing to limited statistical power. By diagnosis, FN was significantly reduced in osteosarcoma (P = 0.045) but did not reach significance in other diagnostic subgroups. No significant differences were observed in chemotherapy dose intensity, number of cycles, or length of hospital stay. Prophylactic pegfilgrastim significantly reduced FN and severe neutropenia compared with therapeutic filgrastim in musculoskeletal tumor chemotherapy, suggesting that it may offer a clinically meaningful benefit in this patient population and warranting further prospective investigation.

PMID 42754481
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