KCENTRA®

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—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. KCENTRA is for intravenous use only.

• Measurement of INR prior to treatment and close to the time of dosing is important because coagulation factors may be unstable in patients with acute major bleeding or an urgent need for surgery and other invasive procedures. • Individualize KCENTRA dosing based on the patient’s current pre-dose International Normalized Ratio (INR) value, and body weight (see Table below).
• The actual potency per vial of Factors II, VII, IX and X, Proteins C and S is stated on the carton. 
• Administer Vitamin K concurrently to patients receiving KCENTRA. Vitamin K is administered to maintain Vitamin K-dependent clotting 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. 
• Dose ranging within pre-treatment INR groups has not been studied in randomized clinical trials of KCENTRA. 

^{*Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 20–31 Factor IX units/mL after reconstitution. The actual potency for 500 unit vial ranges from 400–620 units/vial. The actual potency for 1000 unit vial ranges from 800–1240 units/vial.
†Units refer to international units.
‡Dose is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, maximum dose should not be exceeded.}

How to administer KCENTRA

• Do not mix KCENTRA with other medicinal products; administer through a separate infusion line
• Use aseptic technique when administering KCENTRA
• Administer at room temperature
• Administer by intravenous infusion 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)
• Administer concurrently with vitamin K
• No blood should enter the syringe, as there is a possibility of fibrin clot formation

Storing KCENTRA after reconstitution

• KCENTRA must be used within 4 hours following reconstitution. Reconstituted product can be stored at 2–25°C. If cooled, the solution should be warmed to 20–25°C prior to administration
• Do not freeze the reconstituted product. Discard partially used vials