Is Kcentra an orphan drug?

In December 2012, the FDA granted Orphan Drug Designation to Kcentra for the treatment of patients needing urgent reversal of Vitamin K antagonist therapy due to major bleeding and/or surgical procedures.

What class is Kcentra?

Kcentra is a purified, heat-treated, nanofiltered and lyophilized non-activated four-factor Prothrombin Complex Concentrate (Human) prepared from human U.S. Source Plasma (21 CFR 640.60). It contains the Vitamin K dependent Coagulation Factors II, VII, IX and X, and the antithrombotic Proteins C and S.

Is Kcentra FDA approved?

The U.S. Food and Drug Administration (FDA) announced its approval of Kcentra (Prothrombin Complex Concentrate) on April 30. The drug, a first-in-class therapy, is used for urgent vitamin K antagonist (VKA) anticoagulation reversal in adult patients with acute major bleeding.

What is the generic name for 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 …

How long do the effects of Kcentra last?

Major bleeding despite INR: Administer vitamin K 5-10 mg IV with Kcentra INR will decrease over ~24- 48 hours (oral) and ~12-14 hours (IV); more frequent INR monitoring and additional vitamin K doses may be necessary.

Can you give blood with Kcentra?

Use aseptic technique when administering Kcentra. a maximum rate of 8.4 mL/min (~210 units/min). No blood should enter the syringe, as there is a possibility of fibrin clot formation.

How long does it take for Kcentra to work?

Effective hemostasis measured up to 24 hours for the Acute Major Bleeding trial and until the end of procedure (up to 24 hours) for the Urgent Surgery/Invasive Procedures trial. Rapid INR reduction to ≤1.3 at 0.5 hours after end of infusion.

What is Kcentra used for?

acute bleeding. Kcentra, (Prothrombin Complex Concentrate (Human)), is 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.

How much does Kcentra cost?

Kcentra® is dosed according to Factor IX potency and is individualized based on the patient’s baseline International Normalized Ratio (INR) and body weight. The cost of Kcentra® is $1.27 per unit; a single dose of Kcentra® for an 80 kg patient costs $5,080.