Lenograstim API Manufacturers

General Description:

Lenograstim, identified by CAS number 135968-09-1, is a notable compound with significant therapeutic applications. Lenograstim is a recombinant granulocyte colony-stimulating factor used as an immunostimulating agent.

Indications:

This drug is primarily indicated for: 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). Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Lenograstim undergoes metabolic processing primarily in: Lenograstim is metabolised to peptides. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Lenograstim are crucial for its therapeutic efficacy: 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. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Lenograstim is an important consideration for its dosing schedule: 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. This determines the duration of action and helps in formulating effective dosing regimens.

Route of Elimination:

The elimination of Lenograstim from the body primarily occurs through: Lenograstim is poorly excreted in urine as intact compound (less than 1% of the dose). Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Volume of Distribution:

Lenograstim is distributed throughout the body with a volume of distribution of: Apparent distribution volume (Vd area) is approximately 52 ± 5 mL/kg body weight. This metric indicates how extensively the drug permeates into body tissues.

Clearance:

The clearance rate of Lenograstim is a critical factor in determining its safe and effective dosage: Plasma clearance of lenograstim increased 3-fold (from 50 up to 150 mL/min) during repeated sc dosing. It reflects the efficiency with which the drug is removed from the systemic circulation.

Pharmacodynamics:

Lenograstim exerts its therapeutic effects through: 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. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Lenograstim functions by: 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. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Classification:

Lenograstim belongs to the None, classified under the direct parent group Peptides. This compound is a part of the Organic Compounds, falling under the Organic Acids superclass, and categorized within the Carboxylic Acids and Derivatives class, specifically within the Amino Acids, Peptides, and Analogues subclass.

Categories:

Lenograstim is categorized under the following therapeutic classes: Adjuvants, Immunologic, Amino Acids, Peptides, and Proteins, Antineoplastic and Immunomodulating Agents, Biological Factors, Colony-Stimulating Factors, Cytokines, Glycoproteins, Granulocyte Colony-Stimulating Factors, Hematologic Agents, Hematopoietic Cell Growth Factors, Immunologic Factors, Intercellular Signaling Peptides and Proteins, Peptides, Proteins. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.