KCENTRA contains the Vitamin K-dependent coagulation Factors II (FII), VII (FVII), IX (FIX), and X (FX), together known as the Prothrombin Complex, and the antithrombotic Protein C and Protein S. A dose-dependent acquired deficiency of the Vitamin K-dependent coagulation factors occurs during Vitamin K antagonist treatment. Vitamin K antagonists exert anticoagulant effects by blocking carboxylation of glutamic acid residues of the Vitamin K-dependent coagulation factors during hepatic synthesis, lowering both factor synthesis and function. The administration of KCENTRA rapidly increases plasma levels of the Vitamin K-dependent coagulation Factors II, VII, IX, and X as well as the antithrombotic Proteins C and S. See package insert for complete information.

KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with:
• acute major bleeding or
• need for an urgent surgery/invasive procedure

For intravenous use after reconstitution only.
• KCENTRA dosing should be individualized based on the patient’s baseline International Normalized Ratio (INR) value, and body weight.
• Administer Vitamin K concurrently to patients receiving KCENTRA to maintain factor levels once the effects of KCENTRA have diminished.
• The safety and effectiveness of repeat dosing have not been established and it is not recommended.
• Administer reconstituted KCENTRA at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min). See package insert for complete information.

•The most common adverse reactions (ARs) (frequency ≥ 2.8%) observed in subjects receiving KCENTRA were headache, nausea/vomiting, hypotension, and anemia.
• The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.

KCENTRA is contraindicated in patients with:
• Known anaphylactic or severe systemic reactions to KCENTRA or any components in KCENTRA including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin.
• Disseminated intravascular coagulation.
• Known heparin-induced thrombocytopenia. KCENTRA contains heparin.

• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment.
• Arterial and venous thromboembolic complications have been reported in patients receiving KCENTRA. Monitor patients receiving KCENTRA for signs and symptoms of thromboembolic events. KCENTRA was not studied in subjects who had a thrombotic or thromboembolic (TE) event within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months.
• KCENTRA is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.