Single-dose administration

Patient’s pretreatment INR and body weight determine dose

Dosage calculator

Quickly calculate the recommended dose for your patient

Enter the patient's body weight below and select the appropriate pretreatment INR:

ENTER BODY WEIGHT
kg
lb
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SELECT PRETREATMENT INR
2-<4.0
4.0-6.0
>6.0
KCENTRA DOSE
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Kcentra dose is calculated using Factor IX content

Factor IX content
Actual Factor IX content (units) is printed on each vial

Kcentra Quick Guide App

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  • Dosage calculator (no Internet connection needed)
  • Educational resources
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A single dose of Kcentra is determined by the patient’s pretreatment INR and weight

Pretreatment INR 2–<4 4–6 >6
Dose* of Kcentra (units of Factor IX)/kg body weight 25 35 50
Maximum dose (units of Factor IX) Not to exceed 2500 Not to exceed 3500 Not to exceed 5000

*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.

  • Repeat dosing is not supported by clinical data and is not recommended
  • Administer Kcentra:
    • 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
    • Concurrently with vitamin K
    • Through a separate infusion line
Top of Page Important Safety Information
Important Safety Information & Indications

Important Safety Information

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

Indications

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.

Please see full prescribing information for Kcentra.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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