lenograstim

Action and Spectrum

Actions and Spectrum: 

lenograstim is a medication that belongs to a class of drugs known as granulocyte colony-stimulating factors (G-CSF). It stimulates the production and release of white blood cells, specifically neutrophils, from the bone marrow. Neutrophils are essential to the immune system and are crucial in defending the body against infections. 

Action: 

Stimulation of Neutrophil Production: lenograstim stimulates the bone marrow to produce and release neutrophils, a type of white blood cell. This action helps increase the number of neutrophils in the bloodstream. 

Mobilization of Neutrophils: lenograstim can also mobilize neutrophils from the bone marrow into the bloodstream more rapidly, helping to replenish neutrophil levels more quickly during conditions associated with neutropenia (a low level of neutrophils). 

Spectrum: 

Neutropenia Treatment: lenograstim is primarily used in patients who have undergone specific medical therapy, such as chemotherapy, which can cause a decrease in the number of white blood cells, including neutrophils. It helps to diminish the risk of infections in these individuals by increasing neutrophil counts. 

Stem Cell Mobilization: lenograstim can mobilize stem cells (including hematopoietic stem cells) into the bloodstream for collection in preparation for stem cell transplantation, especially in patients with certain blood disorders or cancers. 

Bone Marrow Disorders: In some cases, lenograstim may be used to manage certain bone marrow disorders where the production of white blood cells is compromised. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Venous thromboembolism  

Cutaneous vasculitis 

Splenic rupture 

Leucocytosis 

Apheresis-related thrombocytopenia 

Glomerulonephritis 

Splenomegaly 

Headache 

Abdominal pain 

Stomatitis 

Diarrhoea 

Nausea 

Back pain 

Vomiting 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

• Hypersensitivity or Allergy: lenograstim should not be used in individuals with known hypersensitivity or allergy to lenograstim or its components. Signs of an allergic reaction might include itching, swelling, severe dizziness, and difficulty breathing. 
• Myeloid Leukemia: lenograstim should not be used in patients with myeloid leukemia (a type of blood cancer) unless it is part of a specific treatment plan under the guidance of a hematologist or oncologist. 
• Severe Pulmonary Infiltrates or Acute Respiratory Distress Syndrome (ARDS): lenograstim should be used with caution, if at all, in patients with severe pulmonary infiltrates or acute respiratory distress syndrome, as it may exacerbate these conditions. 
• Splenomegaly (Enlarged Spleen): Patients with an enlarged spleen should be closely monitored if lenograstim is used, as it can stimulate the release of neutrophils, potentially causing further complications related to spleen size. 
• Serious Allergic Reactions to E. coli-Derived Products: lenograstim is produced using recombinant DNA technology in E. coli bacteria. Patients with a earlier history of severe allergic reactions to products derived from E. coli should use lenograstim with caution. 
• Severe Chronic Neutropenia: While lenograstim can treat neutropenia, it should be used cautiously in cases of severe chronic neutropenia with a known hypersensitivity to filgrastim, another G-CSF medication. 

Caution 

• Infection Risk: lenograstim is often used to help prevent and treat neutropenia (a low neutrophil count) in individuals undergoing chemotherapy or specific other treatments. While it can diminish the risk of infections, it does not eliminate it. Patients receiving lenograstim should still take precautions to minimize exposure to infections, such as practicing good hand hygiene and avoiding close contact with contagious individuals. 
• Monitoring: Patients receiving lenograstim may require regular monitoring of their blood cell counts to ensure that neutrophil levels are within the desired range. Adjustments to the lenograstim dose may be necessary based on these blood counts. 
• Bone Pain: Some patients may experience bone pain while using lenograstim. This is a common side effect and is usually transient. Patients should inform the healthcare provider if they experience severe or persistent bone pain. 
• Splenomegaly (Enlarged Spleen): Patients with an enlarged spleen should be closely monitored when using lenograstim, as it can stimulate the release of neutrophils, potentially leading to complications related to spleen size. 
• Fluid Retention: lenograstim may cause fluid retention in some patients. Those with a history of heart failure or other cardiovascular issues should be monitored carefully for signs of fluid overload. 
• Lung Issues: Patients with preexisting lung conditions or a history of lung issues should use lenograstim with caution, as it can exacerbate respiratory problems. 
• Use in Pregnancy and Breastfeeding: The safety of lenograstim during pregnancy and breastfeeding is not well established. It should only be used during pregnancy if the potential benefits typically outweighs the potential risks, and breastfeeding should be discontinued during lenograstim treatment. 
• Pediatric and Geriatric Populations: lenograstim is used in pediatric and geriatric populations, but special care should be taken in these groups to ensure proper dosing and monitoring and consideration of any age-related factors. 
• Allergic Reactions: While rare, allergic reactions to lenograstim can occur. Patients should be typically monitored for signs of allergic reactions, including rash, swelling, severe dizziness, and difficulty breathing. 

Pregnancy / Lactation

Pregnancy consideration:  

US FDA pregnancy category: Not assigned. 

Lactation:   

Excreted into human milk: Not known. 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• <b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence, these categories of drugs need to be avoided by pregnant women.    
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

lenograstim is a recombinant human granulocyte colony-stimulating factor (G-CSF) that stimulates the production and release of white blood cells, particularly neutrophils, from the bone marrow. It binds to specific receptors on hematopoietic cells, including neutrophil precursors, and activates intracellular signaling pathways, leading to increased proliferation, differentiation, and mobilization of these cells.

By elevating neutrophil counts, lenograstim helps restore the immune system’s ability to combat infections. It is a valuable therapeutic agent for preventing and managing neutropenia, particularly in cancer patients undergoing chemotherapy, individuals with severe chronic neutropenia, and those undergoing stem cell transplantation. Its pharmacokinetics involve subcutaneous administration, with a relatively short half-life, necessitating frequent dosing to maintain therapeutic effects. 

Pharmacodynamics: 

Mechanism of action: lenograstim is a medication that belongs to a class of drugs known as granulocyte colony-stimulating factors (G-CSF). Its primary mechanism of action is to stimulate the production and release of white blood cells, specifically neutrophils, from the bone marrow. Neutrophils are white blood cells that play a crucial role in the body’s defense against infections.  

Binding to G-CSF Receptors: lenograstim is a recombinant form of human granulocyte colony-stimulating factor (G-CSF). It binds to specific receptors on the surface of hematopoietic (blood-forming) cells, particularly those in the bone marrow. These receptors are known as G-CSF receptors. 

Activation of Intracellular Signaling Pathways: When lenograstim binds to its receptors on hematopoietic cells, it initiates a series of intracellular signaling events. This activation triggers various cellular responses, including: 

• Proliferation: lenograstim stimulates the proliferation (multiplication) of hematopoietic stem and also progenitor cells in the bone marrow. This leads to an increase in the number of cells committed to becoming neutrophils. 
• Differentiation: It promotes the differentiation of these precursor cells into mature neutrophils. This is a critical step in the development of functional white blood cells. 
• Mobilization: lenograstim also facilitates the mobilization of mature neutrophils from the bone marrow into bloodstream. This helps increase the circulating neutrophil count, essential for the body’s ability to fight infections. 

Enhanced Neutrophil Function: Not only does lenograstim increase the production and release of neutrophils, but it also enhances the functional activity of these white blood cells. This makes the neutrophils more effective in identifying and destroying invading pathogens, such as bacteria and fungi. 

Pharmacokinetics: 

Absorption 

lenograstim is typically administered via subcutaneous injection. Subcutaneous administration involves injecting the medication into the fatty tissue under the skin. This route of administration allows for relatively rapid absorption into the bloodstream, with peak blood levels typically occurring within a few hours after administration. The absorption rate might vary slightly depending on the injection site and other factors. 

Distribution 

Once absorbed into the bloodstream, lenograstim is distributed throughout the body. It binds to specific receptors on hematopoietic cells, including neutrophil precursors, in the bone marrow and peripheral blood. This binding triggers cellular responses that increase neutrophil production and release from the bone marrow. lenograstim does not bind significantly to plasma proteins and remains predominantly active in circulation. 

Metabolism 

lenograstim is a recombinant human granulocyte colony-stimulating factor (G-CSF), structurally similar to the naturally occurring G-CSF produced by the body. As a result, it does not undergo significant metabolism in the liver or other tissues. Instead, it exerts its effects directly by binding to its target receptors on hematopoietic cells. 

Elimination and Excretion 

Like many other drugs, lenograstim does not undergo significant hepatic metabolism or renal excretion. Instead, it exerts its therapeutic effects by stimulating the production and also release of neutrophils from the bone marrow. As such, it is not excreted from the body in its active form. Instead, any excess lenograstim not used by the body is gradually cleared from the bloodstream as the neutrophil counts return to normal. 

Adminstartion

Administration: 

lenograstim is a medication typically administered under the supervision of a healthcare professional, and the specific dosing and administration instructions can vary depending on the individual patient’s condition and the reason for using the medication. It is typically given by injection.  

Route of Administration: lenograstim is usually administered as a subcutaneous injection (under the skin). Sometimes, it may be given as an intravenous (IV) infusion. The route of administration will generally depend on the patient’s condition and the healthcare provider’s recommendations. 

Dosage: The dosage of lenograstim can vary widely depending on the patient’s medical condition, body weight, and other factors.  

Frequency of Administration: The frequency of lenograstim injections will also depend on the patient’s needs. It may be administered daily or on a different schedule, as determined by the healthcare provider. 

Injection Site: Subcutaneous injections are typically given in the fatty tissue under the skin. Common injection sites include the thigh, abdomen, or upper arm.  

Proper Technique: Following proper injection techniques is essential to diminish the risk of infection or other complications. This includes using a clean, sterile needle and syringe, rotating injection sites, and avoiding areas with broken skin or bruises. 

Patient Education: Patients or caregivers administering lenograstim injections at home should receive thorough training from a healthcare professional on preparing and administering the injections safely and effectively. This training may include proper medication storage, handling, and disposal. 

Monitoring: Patients receiving lenograstim often require regular monitoring of their blood cell counts to assess the effectiveness of treatment and make any necessary dose adjustments. 

Storage: lenograstim should be stored according to the manufacturer’s instructions, typically in the refrigerator. It should not be frozen, and it should be protected from light. 

Precautions: Patients should be aware of the potential side effects of lenograstim and report any unusual symptoms or reactions to their healthcare provider. Common side effects include bone pain, fever, and injection site reactions. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: lenograstim 

Why do we use lenograstim? 

lenograstim is a medication that belongs to the class of drugs known as granulocyte colony-stimulating factors (G-CSF). It primarily stimulates the production and release of white blood cells, specifically neutrophils, from the bone marrow. Neutrophils are an important immune system component and are crucial in defending the body against infections. Here are the primary uses of lenograstim: 

Neutropenia Associated with Chemotherapy: 

lenograstim is commonly used to treat neutropenia (a low level of neutrophils) that can occur as a side effect of chemotherapy. Chemotherapy can suppress the bone marrow’s ability to produce white blood cells, including neutrophils. lenograstim helps boost neutrophil counts, reducing the risk of infections in cancer patients undergoing chemotherapy. 

Stem Cell Mobilization: 

lenograstim can mobilize hematopoietic stem cells (HSCs) from the bone marrow into the bloodstream. This is done to facilitate the collection of these stem cells for use in stem cell transplantation, often in treating certain hematological disorders or malignancies. 

Severe Chronic Neutropenia: 

In some cases, lenograstim may be used to treat patients with severe chronic neutropenia, where individuals have chronically low neutrophil counts, making them susceptible to recurrent infections. 

Myelodysplastic Syndromes (MDS): 

lenograstim may be considered a treatment option for patients with myelodysplastic syndromes. 

Prevention of Neutropenia in Bone Marrow Transplantation: 

In the context of bone marrow or hematopoietic stem cell transplantation, lenograstim may help prevent or reduce neutropenia and related complications during recovery.