Drug intelligence / Profile preview

balfaxar

Development stage
Approved
Lead developer
Octapharma
Modality
Blood Coagulation Factors → Therapeutic Enzymes → Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

Balfaxar is a non-activated four-factor prothrombin complex concentrate (4F-PCC) containing vitamin K-dependent clotting factors II (prothrombin), VII, IX, and X, as well as antithrombotic proteins C and S. It is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy—such as warfarin—in adult patients who require urgent surgery or invasive procedures. By replenishing these clotting factors, Balfaxar rapidly restores blood coagulation in patients at risk of bleeding due to VKA therapy. Clinical studies have shown that Balfaxar is non-inferior to Kcentra in achieving effective hemostasis and rapid reduction of INR levels. The product is supplied as a lyophilized powder for intravenous use[1][2][3][5][8].

Brand names
Balfaxar
Other names
prothrombin complex concentrate human-lansoctaplex (Europe and Canada)
02

Targets

F2 (Thrombin)F9 (Coagulation Factor IX)F10 (Factor Xa)F7 (Coagulation Factor VII)PROC (Protein C)

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