Prothrombin Complex Concentrate (Human)(pro throm’ ben)
Kcentra, Octaplex
PREGNANCY CATEGORY C
Drug Class
Vitamin K anticoagulant reversal agent
Therapeutic Actions
Pooled concentrate containing vitamin K–dependent clotting factors II, VII, IX, X, and antithrombotic proteins C and S. Provides preformed clotting factors for reversal of vitamin K antagonist–induced acute major bleeding in adults.
Indications
Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (warfarin) in adults with acute major bleeding
Contraindications and Cautions
Contraindicated with known anaphylaxis to components of product; DIC, heparin-induced thrombocytopenia.
Use cautiously with known thromboembolic disorders, pregnancy, lactation.
Available Forms
Single-use vials—400–620 units/vial (measured in units of factor IX)
Dosages
Adults
Base dosage on patient’s pretreatment INR. INR of 2 to less than 4, 25 units/kg IV; maximum, 2,500 units. INR of 4–6, 35 units/kg IV; maximum, 3,500 units. INR of more than 6, 50 units/kg IV; maximum, 5,000 units. Monitor INR during and after treatment.
Pediatric patients
Safety and efficacy not established.
Pharmacokinetics
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