Fibrinogen Human (DB09222): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Safety Profile

I. Introduction and Executive Summary

Fibrinogen human, also known as Coagulation Factor I, is a high-molecular-weight glycoprotein that represents a cornerstone of hemostasis. Synthesized primarily in the liver, it circulates in plasma as the soluble precursor to fibrin, the essential structural component of a blood clot.[1] As a therapeutic agent, Fibrinogen human is a sophisticated biotech product, classified as a blood factor and hematological agent, derived from large pools of human plasma and subjected to rigorous purification and viral inactivation processes.[3] Its fundamental therapeutic principle is replacement therapy: by supplementing deficient or consumed endogenous fibrinogen, it restores the body's capacity to form a stable fibrin clot and achieve hemostasis.[4]

The primary approved indications for Fibrinogen human have evolved significantly over time. Initially developed as a niche orphan drug for the treatment of acute bleeding episodes in patients with rare congenital fibrinogen deficiencies, such as afibrinogenemia and hypofibrinogenemia, its application has expanded dramatically.[7] Driven by a favorable safety profile compared to traditional blood components and robust clinical trial data, its use is now established for managing acquired fibrinogen deficiency (AFD)—a far more common condition encountered in settings of major trauma, complex surgery, and obstetric hemorrhage.[10]