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Profilnine SD is a plasma-derived, three-factor prothrombin complex concentrate (PCC) containing concentrated forms of the vitamin K-dependent coagulation factors II (prothrombin), IX (Christmas factor), and X (Stuart-Prower factor), along with low levels of factor VII and proteins C and S. It is primarily indicated for the prevention and control of bleeding in patients with factor IX deficiency, also known as hemophilia B. Unlike four-factor PCCs, Profilnine SD contains minimal amounts of factor VII. In clinical research conducted by Janssen Research & Development, Profilnine SD was evaluated for its ability to reverse the anticoagulant effects of rivaroxaban, a factor Xa inhibitor, by rapidly increasing endogenous thrombin potential to manage hemorrhage in emergency settings.
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