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Филграстим

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Филграстим

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Филграстим

Quick Facts

Property Description
Active ingredient Filgrastim (recombinant human G-CSF)
Form Solution for injection (in vials or prefilled syringes)
Pharmacological class Myeloid Growth Factor, Colony-Stimulating Factor (L03AA02)
General purpose Increasing neutrophil count to combat infection risk
Origin Biologic drug, Recombinant DNA (rDNA)-derived

Identity and Composition of Филграстим

Филграстим (Filgrastim) is a biologic drug and a hemopoietic factor whose active component is the International Nonproprietary Name (INN) substance filgrastim, a form of recombinant human granulocyte colony-stimulating factor (rhG-CSF). It is formally classified as a myeloid growth factor, a type of protein that naturally regulates the formation of white blood cells. The manufacturing of this drug utilizes specialized recombinant DNA technology, employing E. coli cells to produce the non-glycosylated human protein. The final product is consistently presented as a highly purified, single-ingredient solution for injection, designed for parenteral administration via either the subcutaneous or intravenous route.

Pharmacological Classification and Differentiation

Filgrastim is clinically recognized as a Colony-Stimulating Factor (CSF), specifically targeting the bone marrow to accelerate the production and release of neutrophils. Its action is almost exclusively confined to the granulocyte lineage, making it a focused intervention for neutrophil deficiencies. As an established INN, Filgrastim is the foundational molecule for multiple products, including common biosimilar formulations such as Zarzio and Tevagrastim, which share the same active substance and mechanism of action but differ in their specific regulatory approval pathways.

General Purpose and Essential Role

The general purpose of Filgrastim is to counteract the condition of neutropenia—an abnormally low neutrophil count—by restoring the body's immune capacity. The intervention is used to increase the circulating neutrophil count, thereby enhancing the host's defense against potential bacterial and fungal infections. Filgrastim is listed as an essential medicine, underscoring its role in managing patients with deficiencies in this key infection-fighting cell type.

Regulatory References

  1. WHO Essential Medicines List entry for Filgrastim
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What side effects are possible with Филграстим?

Possible Side Effects and Safety Information

The safety profile of Filgrastim, documented in regulatory sources, is structured by frequency and the organ systems involved. The most frequently observed adverse reactions, classified as Very Common, include bone pain, headache, and pyrexia (fever). Other Common reactions reported are fatigue, nausea, diarrhea, vomiting, and localized pain.

Official Regulatory Safety Classifications

Classification Examples of Officially Listed Reactions
Very Common Bone pain, Headache, Pyrexia (fever), Leukocytosis
Common Fatigue, Diarrhea, Nausea, Epistaxis (nosebleeds)
Uncommon Pseudogout, Cutaneous vasculitis, Rheumatoid arthritis exacerbation

Serious adverse reactions, though less frequent, are explicitly documented in official labeling. These include potentially life-threatening events such as Fatal Splenic Rupture (may manifest as left upper abdominal or shoulder pain), Acute Respiratory Distress Syndrome (ARDS), and severe Allergic Reactions (including Anaphylaxis) that can occur rapidly.

Population-specific safety considerations are noted for certain individuals. For patients with Sickle Cell Disorders, there is an explicit documented risk of severe or fatal Sickle Cell Crises. Long-term use in those with Severe Chronic Neutropenia (SCN) is associated with an observed risk of progression to Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Additionally, the simultaneous use of Filgrastim with chemotherapy and radiation therapy is officially not recommended.

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Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information

The official overdose profile for Filgrastim, as documented in government regulatory sources, centers on the risk of an exaggerated hematopoietic response.

Overdose Manifestations Severe / Life-Threatening Outcomes
Marked Leukocytosis (WBC counts ge 100,000/ mm^3) Splenic rupture (including fatal cases)
Splenomegaly (Enlarged Spleen) Acute Respiratory Distress Syndrome (ARDS)
Capillary Leak Syndrome (CLS) (may be fatal)
Aortitis (inflammation of the aorta)

When to Seek Immediate Medical Help

Regulatory documents mandate immediate medical attention and contact with a healthcare provider for any symptoms suggesting a severe complication, such as those that can arise from excessive exposure. Patients must notify a medical professional immediately if they experience pain in the left upper abdominal area or left shoulder tip, which could signal splenic rupture. Urgent evaluation is also required for signs of ARDS or CLS.

Management and Monitoring

The primary management action for an extreme White Blood Cell count (WBC) is Discontinuation of Filgrastim therapy. Since no specific antidote is known, management focuses on supportive and symptomatic treatment for any resulting complications. Continuous monitoring of Complete Blood Counts (CBCs) is an official requirement to guide management and determine the necessary point of drug cessation.

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Therapeutic Uses of Филграстим

What Филграстим Treats: Main Uses and Benefits

Филграстим is used in situations involving severe, symptomatic discomfort and increased systemic burden due to low white blood cell counts, a condition known as neutropenia. It is applied across key therapeutic domains, including supportive care during high-risk chemotherapy, long-term management of Severe Chronic Neutropenia (SCN), and in restoration procedures for hematopoietic transplants.

In these contexts, Филграстим is commonly used to help manage the risk of febrile neutropenia, which manifests as fever and heightened vulnerability to serious infection. It supports the patient by managing this risk and is intended to support the easing of symptom clusters related to immune deficiencies. A primary patient-oriented benefit is related to support: “It provides support that helps ease the overall symptom burden when immune defenses are temporarily compromised.” The medication is designed to support functional stability and help patients during episodes of heightened discomfort.


Quick Fact: Support for Neutropenia Symptoms
Key Symptoms Addressed Risk of infection, fever associated with neutropenia.
Typical Context Following intensive cytotoxic chemotherapy cycles.
Patient Benefit Focus Supports functional stability and helps ease symptomatic distress.

Regulatory References

  1. NIH MedlinePlus overview
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Eligibility and Restrictions for Use

Who can and cannot use Филграстим?

Absolute Contraindications

Use of Filgrastim is absolutely contraindicated in patients with a known history of serious allergic reactions or hypersensitivity to Filgrastim products, Pegfilgrastim products, or any component derived from E. coli proteins. These proteins are used in the drug's manufacturing process.

Disease and Conditional Restrictions

The medicine is not recommended for patients diagnosed with Chronic Myeloid Leukemia (CML) or Myelodysplastic Syndromes (MDS), and it is approved only for supportive care in non-myeloid malignancies. Use is restricted in individuals with Sickle Cell Disease or trait due to the documented risk of severe, sometimes fatal, crises. Administration is not recommended simultaneously with cytotoxic chemotherapy or radiation therapy.

Population Eligibility Status

Population Group Eligibility Status
Adults & SCN Pediatrics Use is established across approved indications.
Neonates/Infants Safety and effectiveness have not been established.
Older Adults Specific dosage recommendations cannot be made due to a lack of dedicated studies.
Pregnancy Conditional use; only if benefit justifies the potential risk to the fetus.
Severe Renal/Hepatic Impairment Use is allowed; no dose adjustment is required.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of Filgrastim primarily around timing restrictions and potential additive effects, rather than metabolic interactions.


Documented Drug-Drug Interaction Constraints

Category Regulatory Requirement or Status
Administration Timing Co-administration is not recommended in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy, a mandatory separation defined in regulatory labeling.
Additive Hematopoietic Effects Medicines such as lithium must be used with caution, as they are documented to potentiate the release of neutrophils, potentially leading to an additive pharmacodynamic effect.

Pharmacokinetic and Substance Interactions

Regulatory authorities state that no formal drug interaction studies have been performed to evaluate the effect of other medicines on the clearance or plasma concentration of Filgrastim. Consequently, no specific metabolic (CYP-enzyme) or transporter-mediated interactions are officially documented in the prescribing information. Furthermore, there are no known interactions between Filgrastim and common foods or drinks. For patients with sickle cell disease, a severe disease-drug interaction is noted in the official cautions due to the risk of severe sickle cell crises upon receiving granulocyte colony-stimulating factors.

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Mechanism of Action

Targeting the G-CSF Receptor and Initiating Signal Transduction

Филграстим is a synthetic protein that functions as a highly specific agonist for the Granulocyte-Colony Stimulating Factor Receptor (G -CSFR), primarily located on hematopoietic progenitor cells within the bone marrow. Receptor binding induces dimerization and the subsequent activation of intracellular signaling pathways, notably the JAK/STAT and Ras/MAPK cascades. This molecular interaction serves to stimulate the early-stage precursors of white blood cells, dictating their cellular fate and survival.


Stimulating Cellular Proliferation and Systemic Release

By engaging the G -CSFR pathway, the drug significantly stimulates the process of myelopoiesis, the cellular mechanism responsible for forming myeloid-lineage cells, with a specific focus on neutrophils. This action leads to a substantial increase in the rate of production and final maturation of these cells within the bone marrow. Additionally, the drug facilitates the accelerated mobilization and release of mature neutrophils from the bone marrow storage pools directly into the peripheral bloodstream. The physiological consequence of these combined, simultaneous actions is a marked increase in the circulating absolute neutrophil count.

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Dosage and Administration Information

Filgrastim is a biologic product administered parenterally, meaning it is delivered either as a subcutaneous (SC) injection or as a short or continuous intravenous (IV) infusion. The medication is consistently supplied as a solution for injection in single-dose vials or pre-filled syringes and must never be shaken vigorously before use.

The dosage is precisely defined on a microgram per kilogram (mcg/kg) body weight basis, with specific starting doses tied to the established therapeutic indications. For patients receiving myelosuppressive chemotherapy, the standard starting dose is 5 mcg/kg once daily. In contexts such as Bone Marrow Transplantation (BMT) or Peripheral Blood Progenitor Cell (PBPC) Mobilization, the standard starting dose is 10 mcg/kg daily. Pediatric dosing follows the same mcg/kg weight-based calculation as used for adults.

A critical timing constraint is applied relative to cytotoxic therapy: Filgrastim must be initiated at least 24 hours after the completion of chemotherapy and must be withheld within the 24-hour period immediately preceding it. The treatment duration is not fixed but is response-driven, continuing daily until the patient's Absolute Neutrophil Count (ANC) recovers to a designated threshold. For IV administration, dilution must be performed with 5% Dextrose (D5W), as dilution using saline is explicitly prohibited.

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Recent Clinical Evidence

Research evidence / Overview of studies for Филграстим


Evidence for Use in Chemotherapy Support (CIN)

Research was extensively conducted using short-term Randomized Controlled Trials (RCTs) and large-scale Meta-analyses. These studies explored the medicine in adults and older adults undergoing chemotherapy for conditions like solid tumors. Research examined how this medicine was associated with outcomes related to episodic or acute changes during chemotherapy cycles, such as the frequency and length of Severe Neutropenia (SN) events and related fever. Studies reported patterns related to the duration of hospitalization and the use of intravenous antibiotics. Research has been limited in establishing patterns related to overall survival duration, and long-term effects are not fully established in this context.


Evidence for Use in Severe Chronic Neutropenia (SCN)

Filgrastim was studied for use in chronic neutropenia, which is a condition characterized by fluctuating manifestations. The evidence base includes initial short-term trials followed by extensive Prospective Observational Registries that have monitored patient progress over many years. Research examined outcomes related to systemic or functional imbalance by monitoring the Absolute Neutrophil Count (ANC), a key biomarker, and outcomes describing episodic or acute changes, such as the number of infections and hospitalizations experienced over time. Long-term registry data show patterns related to measured changes in the ANC. Although these registries provide long duration data, their observational nature means they do not establish causation, and monitoring for rare complications was observed in some studies as part of ongoing research.


Evidence for Stem Cell Mobilization

This section will review the clinical trials, including Controlled and Comparative Studies, that examined the medicine in the context of stimulating and enabling the collection of peripheral blood stem cells for transplantation procedures. Research monitored outcomes related to functional imbalance, specifically the yield of CD34+ cells (a key biomarker), and the time required for successful cell collection (apheresis). Subsequent studies also monitored the time required for the patient's blood counts to recover after transplantation. Comparative evidence is lacking for certain specific combinations or protocols, and the results apply only to the populations studied using the mobilization regimens defined in the original research.

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Frequently Asked Questions (FAQ)

Common questions about Филграстим (FAQ)


Q: Is Филграстим the same medicine as Neupogen?

Yes, they contain the same active ingredient. Filgrastim is the active substance, and Neupogen is the brand name of the original reference product. The market also includes other products, called biosimilars, that contain filgrastim and are considered highly similar to Neupogen.


Q: What is the difference between Филграстим and Pegfilgrastim?

The official product information clarifies that Pegfilgrastim is a modified, sustained-duration form of filgrastim. This modification prolongs the drug's effect in the body. As a result, pegfilgrastim is typically described as being given as a single dose per chemotherapy cycle, unlike filgrastim, which is typically administered daily.


Q: How quickly does Филграстим start working after the first injection?

Studies indicate that a transient increase in the absolute neutrophil count is typically observed in the bloodstream within 1 to 2 days following the start of administration. The full recovery of white cell counts depends on the underlying condition and continues throughout the treatment duration.


Q: How long do the effects of Филграстим typically last?

According to regulatory product information, after the treatment is stopped, the circulating neutrophil counts generally decline by half within 1 to 2 days. These counts then typically return to the pre-treatment levels within 1 to 7 days.


Q: Why is Филграстим given by injection and not as a pill?

Filgrastim is a type of protein, known as a granulocyte colony-stimulating factor. Regulatory documents indicate that, like many therapeutic proteins, it is poorly absorbed by the body if taken by mouth. Therefore, the medication is administered by injection (subcutaneously or intravenously) to ensure therapeutic effect.


Q: Does Филграстим have an impact on red blood cells or platelets?

The medicine primarily affects neutrophils (a type of white blood cell). However, some regulatory information notes that temporary low platelet counts (thrombocytopenia) and reduced red cell parameters may occur, especially when the drug is used at higher doses.


Q: What should be done if an injection is missed (general logistics)?

Since the medicine must be given on a fixed schedule, official guidelines state that patients should contact their healthcare provider immediately for instructions on how to proceed if a dose is missed or forgotten.


Q: Can a slight redness or bruising at the injection site be expected?

Localized pain is a common side effect described in the product information. Furthermore, administration instructions advise against injecting the medicine into any area that is already red, bruised, or hard, suggesting that localized skin reactions are possible and should be avoided.


Q: What are the conditions under which Филграстим is used for patients with HIV/AIDS?

Regulatory information states that this medicine is approved for treating persistent neutropenia in patients with advanced HIV infection. The purpose is to reduce the risk of bacterial infections when other options to manage low neutrophil counts are determined to be inappropriate.


Q: Can lifestyle factors, like smoking or drinking, affect how Филграстим works?

Official health authority patient guides recommend consulting a healthcare team regarding the use of tobacco products or alcohol while on treatment. These lifestyle factors may potentially worsen side effects or affect the overall efficacy of the treatment.


Q: How long after stopping Филграстим does it take for the drug to leave the body?

The elimination half-life of the drug after subcutaneous or intravenous dosing typically ranges from 2 to 4 hours. Clearance is described as being dependent on the administered dose and the circulating neutrophil count.


Q: What are the symptoms of low white blood cell count that Филграстим is trying to prevent?

The medicine is used to prevent the sequelae of severe neutropenia, which is a very low neutrophil count. Regulatory texts associate this condition with symptoms such as recurrent fever, infections, mouth sores (oropharyngeal ulcers), and a general feeling of being unwell (malaise).


Q: Can Филграстим cause any long-term health problems?

Regulatory research indicates that long-term use in patients with Severe Chronic Neutropenia (SCN) has been associated with an observed risk of progression to MDS or AML (forms of blood cancer). However, long-term studies following healthy stem cell donors have not indicated a significantly increased risk of developing hematological malignancies.


Q: Is Филграстим generally considered appropriate for use during pregnancy or breastfeeding?

For pregnancy, official documents state that use is conditional, and should only be considered if the potential benefit is judged to justify the potential risk to the fetus. For breastfeeding, it is unknown if the medicine passes into human milk, but the poor oral absorption by infants suggests it is unlikely to cause adverse effects.


Q: Are there specific pain relievers that should be avoided while using Филграстим?

Formal drug interaction studies with many common pain relievers have not been performed. Regulatory documents mention that other drugs that can stimulate the release of neutrophils, such as lithium, must be used with caution. Patients are generally advised to consult their healthcare team before taking non-prescription pain relievers.


Q: What were the main findings from the clinical trials for this drug?

Studies consistently demonstrated that the drug administration led to a dose-dependent increase in neutrophil counts. Furthermore, the findings are associated with a reduction in the duration of severe neutropenia and febrile neutropenia (fever with low neutrophils) in patients receiving chemotherapy.


Q: What does the long-term research on repeated Филграстим use indicate?

Long-term patient registries for individuals with SCN have shown an observed association with the development of certain blood cancers (MDS/AML). Conversely, long-term follow-up of healthy peripheral blood stem cell donors has not indicated a significantly increased risk of developing malignancy.


Q: Is it true that patients need to have blood tests frequently while using Филграстим?

Yes. Official guidelines require that the complete blood count (CBC) be monitored before starting chemotherapy. Monitoring must then continue, often twice per week during Filgrastim treatment, until the neutrophil count recovers to the required normal range.


Q: What does the medical evidence say about using Филграстим in children?

Medical evidence supports the established use of filgrastim for children with Severe Chronic Neutropenia (SCN), and the dosage is calculated based on their body weight. However, safety and effectiveness have not been established for use in neonates (infants younger than one month of age).

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How should Филграстим be stored and disposed of?

How to Store and Dispose of Filgrastim

Filgrastim must be stored under specific conditions to maintain its effectiveness, as directed by official regulatory labeling.

Storage Requirement Official Condition
Temperature Refrigerated, between 2 C and 8 C (36 F and 46 F).
Light Protection Keep in the original carton to protect from light until the time of use.
Physical Handling Do not shake the solution; protect from freezing. If accidentally frozen, it may be thawed in the refrigerator only once.

The product is for single use only. Any unused medicine remaining in the vial or syringe must be discarded immediately after the first use. Visually inspect the solution for particles or discoloration before use. All used injection components, including the needle and syringe, must be disposed of in a puncture-resistant sharps container. Keep both the medicine and the disposal container out of the reach of children. Unused or expired medication should be disposed of according to local pharmaceutical waste regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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