Granocyte

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Granocyte

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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.

Overview of Granocyte

Property Description
Active ingredient Lenograstim
Form Powder and solvent for solution for injection/infusion
Pharmacological class Colony-stimulating factor (CSF) / Immunostimulant
General purpose Stimulates neutrophil production
Origin Recombinant (synthetic, biotechnology-derived protein)

Granocyte: Definition and Classification as a Cytokine

Granocyte is a specialized, prescription-only medicine containing the active substance Lenograstim, which is classified as a colony-stimulating factor (CSF) and is grouped among the hematopoietic agents. Lenograstim is a recombinant human granulocyte colony-stimulating factor (rHuG-CSF), a sophisticated synthetic, glycosylated protein manufactured using advanced biotechnology to precisely mimic the structure of the G-CSF protein naturally produced by the human body. This designation confirms the medicine's origin as a laboratory-created substance, a quality that is clinically recognized for its high similarity to the natural human protein structure.

Composition and Pharmaceutical Form (Injection)

The Lenograstim medication is supplied as a single-ingredient product in the form of a sterile powder and solvent for solution for injection/infusion. Its complex, protein-based nature requires this particular format, which is distinct from simple oral medications. The active component is the Lenograstim protein itself, which is reconstituted from the lyophilized powder into an aqueous-based solvent for administration. This form dictates that the medicine must be given via the subcutaneous or intravenous route, ensuring the systemic delivery necessary for the active substance to rapidly target the blood-making centers.

General Function: Supporting Neutrophil Production

The fundamental general purpose of Lenograstim is to act as a leukocyte growth factor, directly instructing the bone marrow to accelerate the creation of key immune components. It works by binding to specific cell surface receptors on progenitor cells, which subsequently stimulates the proliferation and differentiation of neutrophil precursor cells. The overarching benefit of this targeted action is to provide robust support to the immune system by raising the count of functional neutrophils, the white blood cells essential for fighting infections, a support often required during certain medical treatments.

What side effects are possible with Granocyte?

Possible Side Effects and Safety Information

The safety profile of Granocyte (lenograstim) is characterized by adverse reactions officially categorized by frequency and the body system affected, as documented in government regulatory sources.

Classification of Common and Very Common Adverse Reactions

The most prevalent finding, classified as very common, is musculoskeletal pain, which may include bone pain, back pain, chest pain, arthralgia, and myalgia. Regulatory texts note that this pain is more frequent at the start of treatment or during periods of dose escalation. Adverse reactions classified as common include headache, alopecia (hair loss), and common gastrointestinal disorders such as nausea, vomiting, diarrhea, and constipation.

Serious Adverse Reactions and Safety Constraints

Official labeling documents serious adverse reactions that are classified as less common. These include potentially life-threatening events in the Blood and Lymphatic System such as splenic rupture, often preceded by significant splenomegaly, and in the Respiratory System, such as Acute Respiratory Distress Syndrome (ARDS). Serious hypersensitivity reactions, including anaphylaxis, are also officially documented.

Regarding high-level safety constraints, lenograstim is contraindicated in individuals with a known history of hypersensitivity to the active substance. A specific population safety consideration exists for patients with Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukaemia (AML) due to the potential for disease progression, a caution explicitly noted in official regulatory text.

Overdose and Emergency Response

Granocyte Overdose and When to Seek Help

The official overdose information for Lenograstim is centered on the consequences of an exaggerated pharmacological effect, which is the over-stimulation of the hematopoietic system.

Documented Overdose Manifestations and Actions

Domain Official Regulatory Statement
Documented overdose presentations The most likely specific symptom associated with excessive dosing is muscle and bone pain, which may be particularly severe.
Physiological systems affected Hematopoietic system, resulting in leukocytosis (a significant rise in white blood cell counts) and, potentially, thrombocytopenia. Elevated enzyme levels may also be observed.
Mandatory threshold action Overdose management requires immediate action if leukocyte counts exceed the mandated threshold of 50 imes 10^9/ L (post-nadir) or > 70 imes 10^9/ L (during PBPC mobilisation).
When immediate help is required If an individual administers too much Lenograstim, they must tell a doctor or go to the hospital straight away; this action is explicitly required.

Resulting Overdose Structure

Official overdose statements:

  • Overdosage is associated with a risk of exaggerated pharmacological effect, primarily manifested as severe leukocytosis and musculoskeletal pain.
  • There is no specific antidote documented in the regulatory labeling for Lenograstim overdose.
  • Management includes clinical observation and the mandated immediate discontinuation of the medicine when specific leukocyte count thresholds are exceeded.

Regulatory documents define the Lenograstim overdose profile by the clinical and laboratory consequences of over-stimulation of the hematopoietic system. Emergency-seeking conditions are triggered both by the administration of too much medicine and by the resulting laboratory findings, necessitating immediate medical consultation for observation and mandated drug discontinuation to mitigate the effects of excessive cell counts.

Therapeutic Uses of Granocyte

Quick Facts: Granocyte Uses

  • Supportive Care After Chemotherapy: May help reduce the time a patient experiences low neutrophil counts (severe neutropenia) following certain cancer treatments.
  • Bone Marrow Transplantation (BMT): May support the recovery of a low neutrophil count after a patient receives an autologous or allogeneic BMT.
  • Stem Cell Mobilization: May be used in patients or healthy donors to encourage the production and collection of peripheral blood progenitor cells (PBPCs) for subsequent transplantation.

Granocyte (lenograstim) is utilized in various clinical contexts to manage conditions where the number of neutrophils, a specific type of white blood cell, is significantly reduced. This reduction is known as neutropenia, a state that may increase the potential for infection.

The medication is indicated for use in adult and pediatric patients (over 2 years) to reduce the duration of neutropenia and associated complications following established cytotoxic chemotherapy. By supporting the production of these infection-fighting cells, the therapy may help to mitigate the risk of severe infection after intensive cancer treatment.

Furthermore, Granocyte is indicated to support hematopoietic recovery after myeloablative therapy followed by bone marrow transplantation (BMT). It may also be administered to patients and healthy donors to facilitate the process known as mobilisation of peripheral blood progenitor cells (PBPCs).

Eligibility and Restrictions for Use

Who can and cannot use Granocyte?

The eligibility for Granocyte (lenograstim) is strictly defined by regulatory authorities based on specific patient characteristics and clinical status.

Granocyte is allowed for use in adults, adolescents, and children older than 2 years for conditions like reduction of neutropenia following cytotoxic chemotherapy or after bone marrow transplantation (BMT). It is also authorized for use in healthy donors between 18 and 60 years for stem cell mobilization.


Absolute Contraindications (Who Must Not Use)

The medicine is contraindicated for patients with a known hypersensitivity to lenograstim or its excipients. It must not be administered to patients with myeloid malignancy other than specific, officially sanctioned subtypes of de novo Acute Myeloid Leukaemia (AML). Specifically, de novo AML patients under age 55 or those with good cytogenetics are strictly excluded.


Restrictions and Conditional Use

Safety and efficacy have not been established in children under 2 years of age. Use is not recommended in women who are pregnant or breastfeeding unless deemed absolutely necessary. Caution is officially advised for patients with pre-existing kidney disease, liver disease, sickle cell disease, or any pre-malignant myeloid condition. Granocyte must also not be administered concurrently with cytotoxic chemotherapy, and its use to increase chemotherapy dose intensity is not permitted.

What should I know about interactions with other medicines?

Granocyte Interactions with other medicines and products

Granocyte (lenograstim) has an official interaction profile primarily defined by administration timing constraints and pharmacodynamic effects. The regulatory labels state that no formal drug-drug interaction studies have been performed to assess pharmacokinetic interactions. Consequently, official documentation lacks specific information regarding the effect of co-administered medicines on Lenograstim's plasma exposure (AUC/Cmax) or its clearance mediated by cytochrome P450 enzymes or drug transporters.

The most critical regulatory requirement is the mandatory timing rule for co-administration with certain cancer treatments.

Interacting Substance Official Interaction Classification Regulatory Requirement
Cytotoxic Chemotherapy Administration Timing Restriction Must not be administered from 24 hours before to 24 hours after completion of chemotherapy.

Pharmacodynamic interactions are limited to cautions regarding additive effects. Caution is officially advised for concomitant use with medicines that may potentiate the release of neutrophils, such as Lithium, due to the potential for an increase in hematopoietic activity. Regulatory documents also note that the drug class can potentiate the myelosuppressive effects of antimetabolites, such as 5-Fluorouracil.

Additional notes in the labeling include a caution for patients undergoing stem cell mobilization who are receiving anti-coagulant treatment, as well as a specific warning for patients with Phenylketonuria (PKU), which is related to the presence of the excipient phenylalanine.

Mechanism of Action

Granocyte (lenograstim) is a recombinant form of human Granulocyte Colony-Stimulating Factor (G-CSF). It acts strictly within the hematopoietic system by binding to and activating the specific G-CSF receptor (CSF3R), which is primarily expressed on myeloid progenitor cells and mature neutrophils.

This binding initiates receptor-mediated signaling, engaging intracellular cascades such as the JAK/STAT pathway. These activated cascades stimulate the survival, proliferation, and differentiation of committed neutrophil precursors within the bone marrow, specifically affecting the myeloid lineage. The resulting physiological consequence is an increase in the production of neutrophils, a key component of the white blood cell population.

Additionally, Granocyte engages mechanisms that alter the adhesion and migration profile of early blood-forming cells. This action promotes the egress of hematopoietic progenitor cells (HPCs), including CD34^+ cells, from the bone marrow niche into the peripheral blood compartment.

Dosage and Administration Information

How to use Granocyte (Lenograstim) — Official Administration Guidelines

Granocyte must be administered only in collaboration with an experienced oncology and/or haematology centre. It is given as a daily injection either subcutaneously (SC) under the skin or as a 30-minute intravenous (IV) infusion diluted in isotonic saline solution.

Preparation and Dosing

The powder must be reconstituted with 1.0 mL of sterile Water for Injections before use, taking care not to shake the vial. The dosage is determined by a healthcare professional based on the treatment context, typically calculated by body surface area (m^2) or body weight (kg).

Treatment Context Daily Dose (Adults) Route
Chemotherapy-Induced Neutropenia/BMT 150 µg/m^2 or 5 µg/kg SC or 30-min IV Infusion
PBPC Mobilisation (after chemotherapy) 150 µg/m^2 SC
PBPC Mobilisation (with Granocyte alone) 10 µg/kg SC

Administration Timing and Schedule

Administration must not begin within 24 hours of the completion of cytotoxic chemotherapy or bone marrow infusion. Treatment is given daily and continues until the expected severe white blood cell count drop (nadir) has passed and the neutrophil count has returned to a stable level compatible with discontinuation, generally for a maximum of 28 consecutive days. For subcutaneous injections, the site should be varied daily. If a dose is missed, patients should skip the missed dose if it is almost time for the next dose; otherwise, take it as soon as remembered, but do not take a double dose.

Monitoring

Regular monitoring of the white blood cell count is mandatory. Treatment should be immediately discontinued if the leukocyte count exceeds 50 imes 10^9/L after the expected nadir (or 70 imes 10^9/L during PBPC mobilisation).

Recent Clinical Evidence

Clinical Research Summary for Granulocyte Colony-Stimulating Factor (G-CSF)

Clinical trials involving lenograstim, the active compound in Granocyte, and other recombinant G-CSF agents have consistently focused on their role as supportive care in oncology and hematology. These studies primarily investigate the agent's connection to the recovery of neutrophils, a type of white blood cell, following treatments that suppress bone marrow function.

Evidence in Chemotherapy-Induced Neutropenia

Numerous randomized, controlled studies across various cancer types (including solid tumors and lymphomas) have explored whether G-CSF is associated with changes in the incidence and duration of febrile neutropenia (FN)—a serious complication of chemotherapy. Meta-analyses incorporating these trials generally indicate that the use of G-CSF reduces the risk of FN and may contribute to a reduced risk of infection-related death in these settings. Specifically, G-CSF use is associated with a shorter period of severe neutropenia after chemotherapy cycles.

Mobilization and Transplant Studies

Research has also investigated the use of G-CSF for mobilizing hematopoietic progenitor cells from the bone marrow into the peripheral blood. This process is essential for collecting blood stem cells for subsequent autologous or allogeneic transplantation. Studies have shown that G-CSF administration is associated with quicker recovery times for both neutrophils and platelets post-transplant, which may reduce the duration of required antibiotic therapy and hospital stay.

Key Studies & References Guidelines for the use of G-CSF for peripheral blood stem cell mobilization and collection in healthy donors and patients: A consensus report

Frequently Asked Questions (FAQ)

Common questions about Granocyte (FAQ)

Q: Is Granocyte a type of chemotherapy or an antibiotic?

A: Granocyte is classified as a cytokine, specifically a granulocyte colony-stimulating factor (G-CSF). Its purpose, as described in regulatory documents, is to stimulate the production of white blood cells. It is not a chemotherapy agent (which targets cancer cells) nor is it an antibiotic (which targets bacteria).

Q: How quickly does Granocyte start to work after the first injection?

A: Regulatory documents indicate that Granocyte works by stimulating the bone marrow to produce new neutrophils, a type of white blood cell. However, the official product information does not specify the exact timeline or hour-by-hour onset of action for when the first measurable rise in blood counts will occur after the initial injection.

Q: Does Granocyte help with all types of infections?

A: The official purpose of Granocyte is to increase the count of neutrophils, which are white blood cells that help fight certain infections. The drug is authorized for use to reduce the risk and duration of infections associated with having a low neutrophil count (neutropenia). It is not described as an anti-infective agent intended to manage all possible types of infections.

Q: Are there any long-term side effects associated with using Granocyte?

A: The provided regulatory safety information describes common and serious short-term adverse reactions. Regulatory warnings also include a specific caution regarding the use of G-CSF in patients with certain pre-malignant blood disorders, such as Myelodysplastic Syndromes (MDS), due to the possibility of disease progression.

Q: What is the difference between Granocyte and other similar white blood cell boosters?

A: Granocyte contains the active substance lenograstim. This is a recombinant human G-CSF protein that is glycosylated, meaning it has sugar molecules attached. This manufacturing process creates a sophisticated protein structure that mimics the natural protein produced by the human body.

Q: Do I need to store Granocyte in the refrigerator all the time?

A: Unopened vials must be kept in the original pack and stored in a cool, dry place below 30 C (room temperature). However, once the powder is reconstituted (mixed with the solvent), the solution must be stored in a refrigerator (2 C–8 C) and used within 24 hours, according to official storage rules.

Q: Is Granocyte appropriate for people with sickle cell anemia?

A: Caution is officially advised for patients who have pre-existing sickle cell disease or sickle cell trait. This caution is noted in regulatory warnings because there have been reports of sickle cell crises occurring with the use of G-CSF agents in these individuals.

Q: Can a patient with a history of allergies use Granocyte?

A: Granocyte is officially contraindicated (must not be used) in individuals with a known history of hypersensitivity (severe allergy) to the active substance, lenograstim, or any of its non-active ingredients (excipients). Serious allergic reactions, including anaphylaxis, have been documented in official labeling.

Q: Does Granocyte affect a woman's ability to get pregnant?

A: Official regulatory warnings advise against the use of Granocyte in women who are pregnant or breastfeeding. In regulatory chemical safety information, the substance lenograstim has a classification of caution regarding potential damage to fertility or the unborn child.

Q: Does Granocyte affect the results of other medical tests?

A: Yes. Regulatory documents note that in addition to the expected increase in white blood cells, other laboratory changes may occur. These changes can include a decrease in platelet counts and an increase in certain enzyme levels, though these effects typically reverse after treatment is stopped.

Q: Why is it important to increase white blood cell counts?

A: The drug's primary function is to address neutropenia—a dangerous drop in the neutrophil count following treatments like chemotherapy. Official documents highlight that this condition is associated with a significantly increased risk of severe infections, which the drug is authorized to help reduce.

Q: How does Granocyte's mechanism differ from that of erythropoietin?

A: Granocyte (lenograstim) is a Granulocyte Colony-Stimulating Factor (G-CSF) that regulates the formation and function of neutrophils (a type of white blood cell). In contrast, erythropoietin (EPO) is a different factor that specifically regulates the production of erythrocytes (red blood cells).

Q: Can Granocyte cause a fever?

A: Fever is listed as an undesirable effect that has been reported in clinical studies documented in regulatory sources. However, in many contexts, fever may also be a symptom of the underlying condition being treated (such as infection due to neutropenia).

Q: What are the specific conditions that make someone ineligible for Granocyte?

A: Official restrictions state the drug is contraindicated for those with hypersensitivity to the drug or certain myeloid malignancies, including specific subtypes of Acute Myeloid Leukaemia (AML). Use is also not recommended for children under 2 years of age or during pregnancy.

Q: What kind of monitoring is typically done during Granocyte treatment?

A: Official labeling states that regular monitoring of white blood cell counts is mandatory during treatment to ensure the counts are increasing appropriately and to ensure the counts do not exceed specified safety limits. Monitoring may also include other blood cell parameters, such as platelets.

Q: Is Granocyte used for conditions other than cancer treatment?

A: Yes, it is. In addition to supportive care following cancer treatment and bone marrow transplantation, official regulatory labels authorize the use of Granocyte for patients with certain inherited or chronic blood conditions, such as severe chronic neutropenia.

Q: Does Granocyte affect my normal blood pressure?

A: Hypotension (low blood pressure) has been reported as an undesirable effect in official documents. This is listed as an adverse reaction, particularly when associated with other serious events like severe hypersensitivity reactions.

Q: What happens if I miss a dose of Granocyte?

A: Official administration instructions advise that if a dose is missed, patients should generally take it as soon as it is remembered. However, the regulatory administration instructions state that one should not take a double dose to compensate for the missed dose.

Q: Can Granocyte be used in children?

A: The medicine is officially authorized for use in adults, adolescents, and children older than 2 years for specific approved conditions. Safety and efficacy have not been established for children under 2 years of age.

Q: Are there any specific blood tests required before starting Granocyte?

A: The need for baseline blood tests is a clinical decision based on the underlying condition. However, regulatory documents state that regular monitoring of blood cell counts is mandatory during treatment, which includes checks on white blood cells and platelets.

Q: Can Granocyte treatment be stopped abruptly?

A: Official documents define when treatment is to be stopped, such as when the neutrophil count returns to a stable, safe level. Official guidance indicates that the drug is to be discontinued if the white blood cell count exceeds specific limits.

Q: What if I experience a severe side effect (e.g., trouble breathing)?

A: Official labeling documents severe adverse reactions, including Acute Respiratory Distress Syndrome (ARDS—severe breathing difficulty) and anaphylaxis. Regulatory documents describe that the drug may require discontinuation by a healthcare professional in the event of serious or unexpected adverse reactions.

Q: Has Granocyte been studied for use in autoimmune diseases?

A: Granocyte is officially authorized only for specific conditions like neutropenia following chemotherapy and severe chronic neutropenia. Official therapeutic indications in regulatory documents do not include the treatment of autoimmune diseases.

Q: Does Granocyte affect the body's natural immune response?

A: The drug is specifically designed to affect the immune system by stimulating the myeloid lineage of cells in the bone marrow. Its main effect is increasing the count of neutrophils, which are key white blood cells essential for fighting bacterial and fungal infections.

Q: Is there a maximum amount of time a patient can be on Granocyte?

A: For chemotherapy-induced neutropenia, treatment is generally limited to a maximum of 28 consecutive days. For patients with authorized chronic conditions, long-term administration is required to maintain the necessary neutrophil count, as described in official posology guidelines.

Q: Can Granocyte affect kidney function?

A: Caution is officially advised for patients who have pre-existing impaired renal function (kidney disease). Furthermore, the official adverse reaction list includes reports of glomerulonephritis (inflammation of the kidney) in patients and donors who have received lenograstim.

Q: Why is Granocyte sometimes necessary after high-dose chemotherapy?

A: High-dose chemotherapy often results in significant suppression of the bone marrow. Granocyte is indicated in this setting to actively stimulate neutrophil recovery following procedures like bone marrow transplantation, thereby reducing the risk of associated serious infections.

Q: Is Granocyte considered a biological medicine?

A: Yes. Granocyte contains lenograstim, which is described in official documents as a recombinant human granulocyte colony-stimulating factor (rHuG-CSF). This designation means it is a synthetic protein manufactured using biotechnology, classifying it as a biological medicine.

How should Granocyte be stored and disposed of?

Official Storage and Disposal Rules for Granocyte

Granocyte (lenograstim) has strict storage and handling requirements that must be followed precisely to maintain the quality of this protein-based medicine, according to official regulatory documentation.

Storage Requirements

Condition Requirement
Unopened Vials Must be kept in the original pack and stored in a cool, dry place below 30°C.
Freezing Do not freeze the medicine under any circumstances.
Prepared Solution After reconstitution, the solution must be stored in a refrigerator (at 2°C–8°C) and discarded if not used within 24 hours.
Safety Keep the medicine out of the sight and reach of children.

Disposal Instructions

Granocyte vials are intended for single-use only; any remaining portion must be discarded. To protect the environment, unused or expired product must not be disposed of via household waste or poured down a sink. Instead, all unused medicine must be returned to a pharmacist for appropriate disposal.

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

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