Active Pharmaceutical Ingredients

CAS NO.1802998-75-9

Property	Details
Chemical Name	Filgrastim
CAS Number	121079-57-8
Molecular Formula	Composed of a polypeptide chain. The exact formula represents the sequence of amino acids in the protein. For recombinant human filgrastim, it consists of 175 amino acids with a molecular formula approximately corresponding to the sum of its amino acid components.
Molecular Weight	Approximately 18,800 Da
Molecular Structure	Filgrastim is a recombinant form of human granulocyte – colony stimulating factor (G – CSF). It has a complex three – dimensional structure determined by the folding of its polypeptide chain. The structure contains alpha – helical regions and loops, which are crucial for its interaction with the G – CSF receptor on target cells.
Appearance	Usually appears as a sterile, colorless to slightly yellow, clear, and viscous solution when formulated for injection.
Solubility	Soluble in aqueous solutions, which is suitable for its formulation as an injectable drug. The formulation often contains buffers and stabilizers to maintain solubility and stability.
Pharmacological Class	Hematopoietic growth factor
Mechanism of Action	Filgrastim binds to specific receptors on the surface of hematopoietic progenitor cells in the bone marrow, especially those committed to the neutrophil lineage. This binding stimulates the proliferation, differentiation, and activation of these cells, leading to an increase in the production of neutrophils. Neutrophils are important white blood cells involved in the body’s defense against infections. By enhancing neutrophil production, filgrastim helps to improve the immune system’s ability to fight off bacterial and fungal infections, particularly in patients with neutropenia (low neutrophil counts).
Medical Applications	Cancer Chemotherapy – Induced Neutropenia: Widely used in cancer patients receiving chemotherapy. Chemotherapy drugs often suppress the bone marrow’s ability to produce white blood cells, including neutrophils. Filgrastim is administered to prevent or reduce the duration and severity of chemotherapy – induced neutropenia, thereby decreasing the risk of infections in these patients. Bone Marrow Transplantation: Used in patients undergoing bone marrow transplantation to accelerate neutrophil recovery. It helps the transplanted bone marrow to engraft more quickly and produce sufficient neutrophils to protect the patient from infections during the vulnerable post – transplant period. Congenital and Cyclic Neutropenia: Also prescribed for patients with congenital or cyclic neutropenia, which are genetic disorders characterized by low neutrophil counts. Filgrastim can increase neutrophil levels and improve the patient’s quality of life by reducing the frequency and severity of infections.
Stability	The stability of filgrastim formulations depends on factors such as storage temperature, pH, and presence of stabilizers. In general, it should be stored in a refrigerator (2 – 8 °C) to maintain its activity. Exposure to higher temperatures, freezing, or extreme pH values can cause denaturation of the protein and loss of its biological activity. Once reconstituted, the solution should be used within a specific time frame as per the product label to ensure its safety and efficacy.
Safety Considerations	Common side effects include bone pain, which is thought to be due to the increased activity in the bone marrow. Other side effects may include headache, fatigue, nausea, and injection – site reactions such as redness, swelling, or pain. In rare cases, more serious side effects can occur, such as splenomegaly (enlarged spleen), which may increase the risk of splenic rupture. There is also a small risk of developing allergic reactions, including anaphylaxis, although this is relatively uncommon. Filgrastim may interact with other medications. For example, concurrent use with lithium can increase the release of neutrophils, potentially leading to an excessive increase in neutrophil counts. It is important to monitor patients closely for any signs of adverse effects, especially in those with pre – existing medical conditions such as liver or kidney disease.

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