Converted to activated protein C (APC). APC is serine protease which inactivates factors Va and VIIIa, limiting thrombotic formation. In vitro data also suggest inhibition of plasminogen activator inhibitor-1 (PAF-1) resulting in profibrinolytic activity, inhibition of macrophage production of tumor necrosis factor, blocking of leukocyte adhesion, and limitation of thrombin-induced inflammatory responses.
Therapeutic use
Replacement therapy for severe congenital protein C deficiency for prevention and/or treatment of venous thromboembolism and purpura fulminans.
Pregnancy and lactiation implications
Reproductive studies not performed. Unknown if administration during pregnancy results in fetal harm. Caution during lactation.
Unlabeled use
Contraindications
Hypersensitivity to protein C or any component of the formulation.
Warnings and precautions
Trace amounts of heparin contained within formulation may lead to heparin-induced thrombocytopenia. Formulation may contain trace amounts of mouse protein and/or heparin (hypersensitivity/allergic reactions might occur). Use caution in hepatic or renal impairment (not studied). Increased risk of bleeding may be seen in patients receiving concomitant anticoagulant therapy including thrombolytic agents, heparin, oral anticoagulants, glycoprotein IIb/IIIa antagonists, platelet aggregation inhibitors, and aspirin. Use with caution in sodium-restricted patients. Product of human plasma (may potentially contain infectious agents which could transmit disease).