Drug intelligence / Profile preview

prothrombin complex concentrate (CSL Limited)

Development stage
Discontinued
Lead developer
CSL Behring
Modality
Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

Prothrombinex (specifically Prothrombinex-VF) is a plasma-derived, three-factor prothrombin complex concentrate (PCC) containing human coagulation factors II, IX, and X, with low levels of factor VII. Developed and manufactured by CSL Behring, it is primarily indicated for the rapid reversal of warfarin-associated anticoagulation in patients experiencing major bleeding or requiring emergency surgery. It is also used for the treatment and perioperative prophylaxis of bleeding in patients with congenital deficiencies of factors II, IX, or X when single-factor concentrates are unavailable. Administered intravenously, Prothrombinex-VF works by replenishing the vitamin K-dependent clotting factors depleted by warfarin therapy, thereby restoring the coagulation cascade and promoting thrombin generation. In 2024, the Australian National Blood Authority initiated a transition to replace Prothrombinex-VF with four-factor PCCs (Beriplex P/N and Beriplex AU).

Brand names
ProthrombinexProthrombinex-VFProthrombinex-HT
Other names
human prothrombin complexfactor IX complexthree-factor prothrombin complex concentrate3-factor prothrombin complex concentrate
02

Targets

F2 (Thrombin)F9 (Coagulation Factor IX)ATIII (Antithrombin III)F10 (Factor Xa)F7 (Coagulation Factor VII)F5 (Coagulation Factor V)

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