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Лейкостим

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Лейкостим

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Лейкостим

Quick Facts: Лейкостим (Filgrastim)

Property Description
Active ingredient Filgrastim (INN)
Form Injectable aqueous solution (vials and prefilled syringes)
Pharmacological class Hematopoietic growth factor, Granulocyte Colony-Stimulating Factor (G-CSF)
General purpose Stimulates white blood cell production (neutrophils)
Origin Synthetic, Recombinant DNA technology product (Biologic)

What Type of Medicine is Лейкостим?

Лейкостим is a prescription-only biologic medicine whose active ingredient, Filgrastim, is classified as a Granulocyte Colony-Stimulating Factor (G-CSF). This places it within the broader group of hematopoietic growth factors, which are substances that stimulate the bone marrow to produce blood cells. Filgrastim is a complex protein created through recombinant DNA technology, meaning it is a synthetic form engineered to precisely mimic the function of the natural human G-CSF protein found in the body, ensuring accurate cellular recognition and signaling. Hematopoietic growth factors are responsible for regulating the production and differentiation of various blood cell types. This foundational role in stimulating cell growth is clinically recognized for its therapeutic impact on the immune system.


Composition, Form, and General Purpose

The drug is a single-ingredient product containing Filgrastim and is administered as an injectable aqueous solution. The active ingredient, Filgrastim, is a non-glycosylated protein, a specific attribute of its engineered structure. Due to the complexity of the protein, the medicine is supplied in vials or prefilled syringes for delivery via subcutaneous injection or intravenous infusion, utilizing an aqueous base with necessary stabilizing agents. The general purpose of this therapy is to address neutropenia, a condition where the body has a dangerously low count of neutrophils, the primary white blood cells responsible for fighting infection. By actively stimulating the proliferation and maturation of neutrophil progenitor cells, Лейкостим rapidly restores the body's defenses, increasing the neutrophil count and strengthening the patient’s ability to resist bacterial and fungal infections. A typical neutral use scenario involves supporting patients whose white blood cell counts are expected to drop following myelosuppressive chemotherapy.

Regulatory References

  1. NIH: Hematologic Growth Factors
  2. MedlinePlus: Filgrastim Injection
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What side effects are possible with Лейкостим?

Possible Side Effects and Safety Information

The following safety information for Лейкостим is based strictly on official government regulatory documents, detailing documented adverse reactions and safety restrictions.

Serious and Clinically Significant Reactions

Official regulatory information identifies specific serious adverse events that have been documented. These include rare, but potentially life-threatening conditions such as Splenic Rupture (which has resulted in death), Acute Respiratory Distress Syndrome (ARDS), and severe allergic reactions (Anaphylaxis).

Other serious events include Capillary Leak Syndrome (CLS) and kidney-related issues like Glomerulonephritis.

Adverse Reactions by Frequency

Adverse reactions are classified by frequency as reported in clinical studies and post-marketing surveillance:

  • Very Common (1 in 10 patients): Often includes Musculoskeletal Pain (e.g., bone or back pain), and non-specific symptoms such as Headache.
  • Common (1 in 100 to < 1 in 10 patients): Reactions spanning multiple System-Organ Classes, including gastrointestinal (e.g., nausea, diarrhea) and general disorders (e.g., fever, fatigue).

Safety Monitoring and Limitations

Regulatory documentation mandates the frequent monitoring of the patient's complete blood count and platelet counts. Severe increases in white blood cells (Leukocytosis) require treatment to be stopped. Thrombocytopenia (low platelet count) is also a documented risk.

A specific population-based risk is the potential for developing Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). This risk is officially noted as a concern for patients with congenital neutropenia and has also been documented in patients with breast or lung cancer receiving chemotherapy or radiotherapy.

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the overdose profile for filgrastim products (like Лейкостим) based on documented effects observed during clinical study and post-market experience.

The maximum tolerated dose for filgrastim has not been established in human trials. The primary physiological manifestation of an overdose, as described in official labeling, is an excessive increase in white blood cell (WBC) counts, a condition known as leukocytosis.

Documented Overdose Findings

Overdose Manifestation Regulatory Statement
Key Symptom/Sign Leukocytosis (WBC counts over 100,000/mm³).
Associated Risk High WBC counts over 100,000/mm³ have not typically been associated with reported adverse clinical effects.

Required Emergency Action

Official regulatory guidance outlines the immediate steps to be taken in the event of suspected overexposure, focusing on intervention and monitoring:

  • Action for High WBC: The drug should be discontinued if the patient's leukocyte count exceeds 100,000/ mm^3.
  • Resolution: Discontinuation of treatment typically results in a 50% decrease in circulating neutrophils within one to two days, with levels returning to pretreatment range within one to seven days.
  • Urgent Medical Care: If an overdose is suspected, official instructions mandate calling a poison control center or seeking immediate medical care right away.
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Therapeutic Uses of Лейкостим

What Лейкостим Treats: Main Uses and Benefits

The primary therapeutic use of Лейкостим (Filgrastim) is to provide essential supportive care across domains where additional symptomatic support is needed due to severe neutropenia (a low white blood cell count). This medication is commonly used across conditions presenting with acute episodes of immune compromise, which can lead to symptoms related to systemic imbalance.

It is applied in clinical settings that involve acute or unstable symptom patterns, such as after myelosuppressive chemotherapy or bone marrow transplantation, and is also considered relevant in certain severe chronic neutropenia syndromes. This focus helps address symptom clusters that may become intense or disruptive, and is relevant for easing symptoms related to heightened physiological activity.

This provides support that helps ease the overall symptom burden and supports patients during episodes of heightened discomfort, assisting with maintaining functional stability.


Quick Fact: Relevant for Symptoms Associated with Neutropenia Лейкостим is commonly used when short-term symptomatic assistance is needed to address the heightened physiological stress and potential disruption caused by very low white blood cell counts.

Regulatory References

  1. NIH MedlinePlus overview
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Eligibility and Restrictions for Use

Who Can and Cannot Use Лейкостим (Filgrastim)

Official regulatory documents strictly define the patient populations eligible for Filgrastim therapy. Absolute contraindications prohibit its use in individuals with a history of serious allergic reactions to Filgrastim, Pegfilgrastim, or any other G-CSF product, or to any component of the formulation.

Eligibility and Restrictions

Population Category Regulatory Status (Official Labeling)
Contraindicated Groups Patients with known hypersensitivity to G-CSFs or excipients.
Restricted Conditions Use is not recommended in patients with Chronic Myeloid Leukemia (CML) or Myelodysplastic Syndromes (MDS).
High-Risk Groups Use requires extreme caution in patients with sickle cell trait or sickle cell disease due to documented risk of crises.
Pediatric Use Efficacy and safety are established in children and adolescents for the Severe Chronic Neutropenia (SCN) and cancer settings.
Renal/Hepatic Impairment Dose adjustment is not required for patients with severe impairment of renal or hepatic function.
Pregnancy Status Use is permitted only if the potential benefit justifies the potential risk to the fetus. The status regarding lactation is unknown.

Eligibility is defined by these regulatory boundaries, ensuring the medicine is administered only to populations for whom use is formally documented and approved.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Leicostim (Filgrastim) outlines specific administration constraints and pharmacodynamic effects when co-administered with certain substances, while noting a regulatory absence of formal pharmacokinetic interaction data.

Administration Timing Constraints

The most critical regulatory constraint involves concurrent administration with Cytotoxic Chemotherapy (myelosuppressive anti-cancer drugs). Filgrastim must not be administered within the 24-hour period prior to cytotoxic chemotherapy. Furthermore, Filgrastim administration must be separated by at least 24 hours following the administration of cytotoxic chemotherapy or bone marrow infusion. The safety and efficacy of concurrent (simultaneous) administration have not been established in regulatory documentation.

Pharmacodynamic Effects and Restrictions

Classification Interacting Substance Official Description
Use with Caution Lithium Potential for additive hematopoietic effects (increased white blood cell counts) .
Data Absent Other Medicinal Products No formal drug interaction studies have been performed to evaluate pharmacokinetic interactions (e.g., CYP or transporter-mediated effects).

Interactions with Food and Alcohol

Official labeling states there are no known interactions with foods or drinks. The regulatory status of any potential interaction with alcohol or herbal products remains unknown and has not been formally studied.

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Mechanism of Action

How Лейкостим Works

G-CSF Receptor Activation in Myeloid Lineage

Лейкостим (Filgrastim) acts as an agonist by binding to the Granulocyte Colony-Stimulating Factor (G-CSF) receptor located on hematopoietic cells within the bone marrow. This ligand binding initiates a signal transduction pathway that specifically influences the proliferation and differentiation of cells in the committed neutrophil lineage.


Myeloid Progenitor Cell Regulation

Activation of the G-CSF receptor regulates the proliferation of myeloid progenitors, resulting in the accelerated maturation of neutrophil precursors. This targets molecular steps that govern precursor cell expansion and differentiation within the hematopoietic microenvironment.


Systemic Neutrophil Mobilization

By modifying the final stages of the mechanistic cascade, Лейкостим facilitates the rapid release of mature neutrophils from the bone marrow storage pool into the systemic circulation. This release mechanism results in a measured, dose-dependent elevated systemic neutrophil count.

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Dosage and Administration Information

How to use Лейкостим: Official Administration Guidelines

This section outlines the administration procedure for Лейкостим, strictly according to regulatory prescribing information.

Administration Scope Details
Route of Administration Subcutaneous injection (SC) or intravenous (IV) infusion.
Standard Dosing Schedule 5 mug/kg (0.5 MU/kg) once daily. For patients undergoing myeloablative chemotherapy, the dose is typically 10 mug/kg (1.0 MU/kg) once daily.
Timing Relative to Chemotherapy The first dose must be administered at least 24 hours after the completion of cytotoxic chemotherapy. The drug must not be administered in the period from 24 hours before to 24 hours after chemotherapy.

Preparation and Administration Steps

  • Subcutaneous (SC) Use: The drug is typically administered directly via SC injection from the pre-filled syringe or vial, with no prior dilution required.
  • Intravenous (IV) Use: If administration is via IV, the drug must be diluted immediately before use in 5% glucose (dextrose) solution. It must not be diluted to a final concentration less than 1.5 mug/mL.
  • Procedural Note: The solution must not be shaken as this can inactivate the therapeutic protein.

Missed Dose Instructions

If a dose is missed, administer the dose as soon as the patient remembers, and then resume the standard daily schedule. The dose should not be doubled to compensate for the missed administration.

Administration must be overseen by a specialist experienced in oncology and hematology. Daily use continues until the therapeutic target is achieved, such as the required neutrophil recovery or the completion of the planned apheresis procedures.

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Recent Clinical Evidence

Research evidence / Overview of studies for Лейкостим


Evidence for Preventing Complications during Chemotherapy

The primary evidence base for Лейкостим (Filgrastim) comes from short-term Randomized Controlled Trials (RCTs) and meta-analyses that have researched its use in patients receiving myelosuppressive chemotherapy. The studies monitored several key outcomes, including the duration and severity of the low white blood cell count (severe neutropenia) and the incidence of Febrile Neutropenia (FN). The findings describe patterns where the incidence and duration of severe neutropenia and FN were measured as lower in the groups receiving Filgrastim compared to those receiving a placebo or no treatment.

Clinical trial findings described a pattern where the incidence of Febrile Neutropenia was measured as decreased, and the measured duration of hospitalization was shorter in cohorts receiving Filgrastim. However, follow-up durations were limited in most initial trials. Research is limited in establishing a clear difference in long-term Overall Survival (OS) rates across many cancer-related trials.


Evidence Supporting Recovery After Bone Marrow and Stem Cell Transplantation

Research has also evaluated Лейкостим in patients undergoing a bone marrow or stem cell transplant. These studies primarily was observed in trials that measured the time to sustained neutrophil engraftment—how quickly the patient's body started producing white blood cells again. The data show patterns related to measured shifts in the time to neutrophil recovery (engraftment) in transplant recipients who received Filgrastim compared to those who did not. Findings were mixed regarding the recovery of other blood components, such as platelets, suggesting that the results apply only to the populations studied and the specific conditions of the transplant.


What the Research Landscape Leaves Uncertain

While the research describes patterns related to specific short-term outcomes, the evidence highlights what is known and what is still uncertain. For chronic conditions like Severe Chronic Neutropenia, long-term effects are not fully established, and surveillance for rare events relies heavily on observational data rather than controlled trials. Comparative evidence is limited for many non-hematologic outcomes, meaning the full scope of differences in patient-reported experiences or quality of life compared to placebo is uncertain.

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Frequently Asked Questions (FAQ)

Common questions about Лейкостим (FAQ)


Q: Is Лейкостим considered a type of chemotherapy or cancer treatment?

A: According to official product information, Лейкостим is classified as a hematopoietic growth factor, specifically a Granulocyte Colony-Stimulating Factor (G-CSF). Its purpose is to stimulate the bone marrow to produce white blood cells (neutrophils) to fight infection. Official documentation clarifies that this medicine is not a type of cytotoxic chemotherapy.


Q: What are the symptoms of a serious allergic reaction to Лейкостим?

A: Regulatory documents state that serious allergic reactions (anaphylaxis) have been documented with the use of this drug. Symptoms may include swelling of the face, lips, or throat, difficulty breathing, or the development of hives. If these symptoms occur, immediate professional attention should be sought.


Q: Can Лейкостим be taken with over-the-counter pain medications like ibuprofen or paracetamol?

A: Official labeling states there are no known interactions specifically with foods or drinks. For all other medications, including any over-the-counter drugs, official guidance suggests informing their healthcare provider of everything they are taking before starting or continuing therapy.


Q: Does Лейкостим interact with any common vitamins or herbal supplements?

A: The regulatory status regarding interactions with herbal products and supplements is generally unknown, as formal interaction studies have not been performed. Due to this lack of data, patients are advised to inform their healthcare provider of any supplements they may be using.


Q: How long can Лейкостим be kept out of the refrigerator?

A: The drug must be stored in a refrigerator between 2 C and 8 C. If kept at room temperature (typically 9 C to 30 C), the solution is stable for a limited time, such as up to 24 hours. This limited time is defined by the product label and is required for stability.


Q: What is the correct way to dispose of used Лейкостим syringes?

A: Used needles and syringes must be immediately placed into a puncture-proof sharps container. The full sharps container should then be handled and disposed of according to local regulatory and waste management guidelines. This is a regulatory requirement for safe handling and disposal.


Q: Is it possible to become resistant to Лейкостим over time?

A: For patients receiving long-term administration for certain conditions, official documents indicate that the dose may be individually adjusted. This adjustment is based on the patient's measured response to help maintain the required neutrophil count over time.


Q: What is the difference between Лейкостим and pegfilgrastim (single-shot versions)?

A: Both Лейкостим (Filgrastim) and Pegfilgrastim are types of Granulocyte Colony-Stimulating Factor (G-CSF). The primary difference is the duration of effect. Лейкостим is the standard daily-injection formulation, while Pegfilgrastim is a modified, longer-acting version that typically requires fewer injections, often only once per chemotherapy cycle.


Q: Does Лейкостим cause changes to my blood cell counts other than white cells?

A: Yes, regulatory safety information recommends regular monitoring of all blood cell counts, including platelets and red blood cells. The potential for changes means that careful monitoring is required by regulatory guidance, as a low platelet count (thrombocytopenia) is a documented risk.


Q: How quickly does Лейкостим start to raise the white blood cell count?

A: Official studies indicate that a transient increase in neutrophil counts is typically observed within 1 to 2 days after initiating the therapy in patients receiving cytotoxic chemotherapy. Neutrophil recovery is measured over the course of treatment.


Q: What is the maximum length of time a patient is typically given Лейкостим?

A: The duration of therapy is highly dependent on the condition being treated. For chemotherapy-induced neutropenia, it is typically administered for up to two weeks, or until the white blood cell count has recovered to the required level. Other conditions may require long-term, daily administration.


Q: What does a patient need to know about the latex in the prefilled syringe cap?

A: Official labeling notes that the needle cover of the pre-filled syringe may contain dry natural rubber, which is a derivative of latex. This warning is present due to the potential for allergic reactions in individuals with known latex allergy.


Q: Are there any contraindications related to yeast-derived products in Лейкостим?

A: Лейкостим (Filgrastim) is a protein produced in Escherichia coli (a type of bacterium) by recombinant DNA technology. The drug is strictly contraindicated in patients with known hypersensitivity to G-CSFs or any of the inactive ingredients (excipients) in the formulation.


Q: Is Лейкостим used to collect stem cells for a transplant procedure?

A: Yes, Лейкостим is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). This process uses the drug to help move stem cells from the bone marrow into the bloodstream so they can be collected prior to a stem cell transplant.


Q: What are the possible risks of using Лейкостим if my white blood cell count is already high?

A: Regulatory guidance addresses the risk of the white blood cell count becoming severely high, a condition known as Leukocytosis. If this occurs, the official guidance requires the treatment to be stopped by the healthcare provider to manage this risk.


Q: Can Лейкостим cause inflammation of the aorta?

A: Yes, inflammation of the aorta (Aortitis) has been documented as a rare, serious adverse event. Symptoms that have been documented include fever, abdominal or back pain, and unusual tiredness.


Q: What is Capillary Leak Syndrome and is it a reported risk with Лейкостим?

A: Capillary Leak Syndrome (CLS) is a documented serious risk associated with the drug. CLS is a condition where fluid leaks from the blood vessels. Documented symptoms include generalized swelling, difficulty breathing, or low blood pressure (dizziness).


Q: What types of cancer treatment lead to the use of Лейкостим?

A: Official labeling indicates Лейкостим is used in patients receiving established cytotoxic chemotherapy. This includes regimens used to treat various malignancies such as breast cancer, lymphoma, and small-cell lung cancer, where a drop in white blood cell count is expected.


Q: Does the injection site need to be rotated when using Лейкостим?

A: Yes. The site of the subcutaneous injection is advised to be rotated each time the drug is administered. This rotation is advised as a procedural note in the patient instructions for use.


Q: Is it common to experience fatigue while taking Лейкостим?

A: Yes, regulatory documentation lists fatigue as a common adverse reaction, meaning it is seen in 1 in 100 to < 1 in 10 patients. It is a known potential effect of the treatment.


Q: Can Лейкостим be used by children?

A: Official regulatory documents confirm that the efficacy and safety of Filgrastim are established in children and adolescents. It is approved for use in this population for cancer-related neutropenia and Severe Chronic Neutropenia.


Q: How is the intravenous (IV) solution of Лейкостим prepared?

A: For intravenous use, the drug must be diluted immediately before use. Regulatory instructions require it to be mixed in a 5% glucose (dextrose) solution. It must not be diluted to a final concentration less than 1.5,mu g/mL.

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How should Лейкостим be stored and disposed of?

How to Store and Dispose of Лейкостим (Filgrastim)

The storage and disposal of Лейкостим must follow strict regulatory requirements to maintain its stability as a biologic.

Storage Conditions

Requirement Specifics
Temperature Store in a refrigerator between 2 C and 8 C; do not freeze the product.
Protection Keep in the original outer carton to protect the solution from light.
Handling Do not shake the solution vigorously.
Stability If stored at room temperature (below 25 C), discard after the labeled time limit (e.g., 24 to 72 hours, depending on the product label).

Disposal and Safety

Keep this medicine out of the sight and reach of children.

Unused or expired product must not be discarded in household waste or wastewater. Used needles and syringes must be placed immediately into a puncture-proof sharps container in accordance with local regulations.

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

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