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Identification
- Summary
Lenograstim is a granulocyte colony-stimulating factor indicated in the reduction of duration of neutropenia in bone marrow transplant and cytotoxic chemotherapy, as well as mobilizing hematopoietic stem cells in healthy donors.
- Generic Name
- Lenograstim
- DrugBank Accession Number
- DB13144
- Background
Lenograstim is a recombinant granulocyte colony-stimulating factor used as an immunostimulating agent.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Haematopoietic growth factors - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- G-CSF (CHO cell derived)
- Glycosylated recombinant G-CSF
- Glycosylated recombinant granulocyte colony stimulating factor
- Granulocyte colony stimulating factor 3 (CHO cell derived)
- Granulocyte colony-stimulating factor lenograstim
- Lenograstim
- Lenograstim (genetical recombination)
- Lenograstim rDNA
Pharmacology
- Indication
The drug is used to reduce the risk of life-threatening infection in patients with neutropenia, particularly after cytotoxic chemotherapy. Lenograstim is indicated as a treatment to reduce the duration of neutropenia and the severity of infections in patients with non-myeloid malignancy who have undergone autologous or allogeneic bone marrow transplantation, or treatment with established cytotoxic chemotherapy and in addition to reduce the incidence of infection associated with established cytotoxic chemotherapy. Lenograstim is also indicated to mobilise peripheral blood progenitor cells (PBPCs) with Lenograstim alone, or after myelosuppressive chemotherapy, in order to accelerate haematopoietic recovery by infusion of such cells, after myelosuppressive or myeloablative therapy. Lenograstim is also indicated to accelerate the engraftment of these cells after their reinfusion.
GRANOCYTE is also indicated for the treatment of severe chronic neutropenia including congenital agranulocytosis (Kostmann's syndrome).
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form For therapy Neutropenia •••••••••••• •••••••••• ••••••• ••• •••••••• Management of Neutropenia •••••••••••• •••••••••• ••••••• ••• •••••••• Adjunct therapy in management of Neutropenia •••••••••••• •••• •• •••••• ••••••••••• •••••••••• ••••••• ••• •••••••• - Associated Therapies
- Contraindications & Blackbox Warnings
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Lenograstim has been confirmed as a valuable adjunct to minimise the haematological toxicity of myelosuppressive chemotherapy in patients with malignant disease. The drug also enhances neutrophil recovery in patients undergoing stem cell rescue, and assists peripheral blood progenitor cells mobilisation.
- Mechanism of action
Lenograstim is the glycosylated recombinant form of human granulocyte colony stimulating factor. Lenograstim accelerates neutrophil recovery significantly after chemotherapy, with beneficial effects on clinical end-points such as incidence of laboratory-confirmed infection and length of hospital stay. Chemotherapy dose intensity has also been increased in patients receiving lenograstim, notably those with breast or small cell lung cancer, although improvements in tumour response and survival have not been demonstrated. Lenograstim also assists neutrophil recovery in patients undergoing bone marrow transplantation, and stimulates the production of peripheral blood stem cells (PBSCs) for autologous transfusion after aggressive chemotherapy.
Target Actions Organism AGranulocyte colony-stimulating factor receptor agonistHumans - Absorption
During repeated dosing (iv and sc routes), peak serum concentrations (at the end of iv infusion or after sc injection) are proportional to the injected dose. Repeated dosing with lenograstim by the two injection routes results in no evidence of drug accumulation.
- Volume of distribution
Apparent distribution volume (Vd area) is approximately 52 ± 5 mL/kg body weight.
- Protein binding
Not Available
- Metabolism
Lenograstim is metabolised to peptides.
- Route of elimination
Lenograstim is poorly excreted in urine as intact compound (less than 1% of the dose).
- Half-life
The pharmacokinetic profile of lenograstim is similar in healthy volunteers and cancer patients with elimination half-life (t½β) values of 2.3 - 3.3 hrs (volunteers); 2.8-7.5 hrs (cancer patients) following sc administration, and 0.8 - 2.1 hrs (volunteers); 1.1 - 4.0 hrs (cancer patients) following iv administration.
- Clearance
Plasma clearance of lenograstim increased 3-fold (from 50 up to 150 mL/min) during repeated sc dosing.
- Adverse Effects
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Species observed : Human (Man) Test type: TDLo ( Lowest Published Toxic Dose) Route of exposure: Subcutaneous Dose/Duration: 21428mg/kg/15 Toxic Effect: Skin and appendages: Dermatitis, allergic ( after systemic exposure )
Species observed : Rodent - Rat Test type: LD50 Route of exposure: Oral Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value
Species observed : Rodent - Rat Test type: LD50 Route of exposure: Subcutaneous Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value
Species observed : Rodent - Rat Test type: LD50 Route of exposure: Intravenous Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value
Species observed : Mammal - Dog Test type: LD50 Route of exposure: Intravenous Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value
Species observed : Mammal - Dog Test type: LD50 Route of exposure: Subcutaneous Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareCyclophosphamide The risk or severity of pulmonary toxicity can be increased when Lenograstim is combined with Cyclophosphamide. Topotecan The risk or severity of neutropenia can be increased when Lenograstim is combined with Topotecan. Vinblastine The risk or severity of peripheral neuropathy can be increased when Lenograstim is combined with Vinblastine. Vincristine The risk or severity of peripheral neuropathy can be increased when Lenograstim is combined with Vincristine. Vindesine The risk or severity of peripheral neuropathy can be increased when Lenograstim is combined with Vindesine. - Food Interactions
- Not Available
Products
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- Granocyte / Neutrogin
Categories
- ATC Codes
- L03AA10 — Lenograstim
- Drug Categories
- Adjuvants, Immunologic
- Amino Acids, Peptides, and Proteins
- Antineoplastic and Immunomodulating Agents
- Biological Factors
- Carbohydrates
- Colony-Stimulating Factors
- Cytokines
- Glycoconjugates
- Glycoproteins
- Granulocyte Colony-Stimulating Factors
- Hematologic Agents
- Hematopoietic Cell Growth Factors
- Immunologic Factors
- Intercellular Signaling Peptides and Proteins
- Peptides
- Proteins
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- 6WS4C399GB
- CAS number
- 135968-09-1
References
- General References
- Dunn CJ, Goa KL: Lenograstim: an update of its pharmacological properties and use in chemotherapy-induced neutropenia and related clinical settings. Drugs. 2000 Mar;59(3):681-717. [Article]
- Medsafe [Link]
- ChemIDPlus [Link]
- AIFA Product Information: Myelostim (lenograstim) powder for injection [Link]
- External Links
- PubChem Substance
- 347911430
- 70167
- Wikipedia
- Lenograstim
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Recruiting Supportive Care Localized Breast Cancer 1 somestatus stop reason just information to hide Not Available Unknown Status Supportive Care Multiple Myeloma (MM) 1 somestatus stop reason just information to hide Not Available Unknown Status Treatment Neutropenia 1 somestatus stop reason just information to hide 4 Completed Treatment Myocardial Infarction 1 somestatus stop reason just information to hide 4 Completed Treatment Neoplasms (no Otherwise Specified) 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, for solution Intravenous; Subcutaneous 13000.000 IU/ml Injection, powder, for solution Intravenous; Subcutaneous 263 mcg Injection, powder, for solution Intravenous; Subcutaneous 33.6 MIU Injection, powder, for solution Intravenous; Subcutaneous 263 mcg/ml Injection, powder, for solution Intravenous; Subcutaneous 34 mIU/ml Injection, powder, lyophilized, for solution Intravenous 263 µg Injection, powder, for solution Intravenous; Subcutaneous 13 million IU/ml Injection, powder, for solution Intravenous; Subcutaneous 34 million IU/ml Powder 100 mcg/1vial Powder 250 mcg/1vial - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Agonist
- General Function
- Receptor for granulocyte colony-stimulating factor (CSF3), essential for granulocytic maturation. Plays a crucial role in the proliferation, differentiation and survival of cells along the neutrophilic lineage. In addition it may function in some adhesion or recognition events at the cell surface
- Specific Function
- cytokine binding
- Gene Name
- CSF3R
- Uniprot ID
- Q99062
- Uniprot Name
- Granulocyte colony-stimulating factor receptor
- Molecular Weight
- 92155.615 Da
References
Drug created at November 15, 2016 20:43 / Updated at June 08, 2021 11:32