Urgent warfarin reversal
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.
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About warfarin and warfarin reversal
Warfarin is used for prophylaxis and treatment of venous thrombosis, pulmonary embolism, and thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Warfarin is also approved for reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.1 Unfortunately, the most common adverse reaction to warfarin is hemorrhage,1 which is associated with hospital stays, transfusions, endoscopy, surgery, and ICU admission.2 When selecting a warfarin reversal agent, the hemostatic efficacy and time to INR reduction should be considered.3 While physicians may be comfortable with fresh frozen plasma (FFP),4 FFP has presented its own set of risks, namely fluid overload, which is associated with higher total hospital costs and longer hospital and ICU lengths of stay as compared with individuals without fluid overload.5
As an alternative, KCENTRA offers superior* and sustained INR reduction and faster administration, with approximately 85% less volume vs plasma in pivotal trials. In the pivotal trials, there were 9 subjects (4.7%) in the KCENTRA group who experienced fluid overload; all were deemed non–treatment-related. Twenty-five subjects (12.7%) in the FFP group experienced fluid overload; 13 were deemed treatment-related.
KCENTRA offers superior, early INR reduction vs FFP.6,7*
The relationship between INR values and clinical hemostasis in patients has not been established.
ICU, intensive care unit; INR, international normalized ratio.
What is KCENTRA?
KCENTRA 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 need for an urgent surgery/invasive procedure.
KCENTRA is for intravenous use only.
Please see full prescribing information for KCENTRA.
What are the key benefits?
KCENTRA is the #1 prescribed 4F-PCC with the longest record of proven safety and efficacy since 201310
FASTER ACTING*
Superior INR reduction at 30 minutes after end of infusion vs plasma6,7
SUSTAINED
INR,
REDUCTION†
Statistically significant INR reduction sustained ≤1.3 for up to 8 hours in the Urgent Surgery trial and 12 hours in the Acute Major Bleeding trial6,7
FASTER
ADMINISTRATION,
LOWER VOLUME
Mean infusion time is under 25 minutes; ~85% less volume vs plasma6,7
In the largest study to date on 4F-PCC TE events and all-cause mortality, KCENTRA demonstrated no increased risk of TE events and 41% risk reduction in adjusted all-cause mortality vs plasma.8
4F-PCC, 4-factor prothrombin complex concentrate; INR, international normalized ratio; TE, thromboembolic.
*In 2 head-to-head trials, KCENTRA demonstrated superiority to plasma in 3 of 4 efficacy endpoints. Superior hemostatic efficacy in the Urgent Surgery/Invasive Procedures trial and equally effective hemostasis in the Acute Major Bleeding trial. Faster INR reduction (to ≤1.3 at 30 minutes after end of infusion) in both head-tohead trials.
†8 hours for Urgent Surgery/Invasive Procedures trial and 12 hours for Acute Major Bleeding trial. 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 value of KCENTRA
KCENTRA showed significant net reductions in total hospital costs over a 5-year period, and across >550,000 patients, when chosen over fresh frozen plasma (FFP)10
Model assumptions
- Hospitalization costs are derived from real-world evidence using multivariate regression analysis leveraging national database consisting of over 550,000 patients
- Current KCENTRA WAC Price; Current FFP WAC Price*
- The hospital will receive 262 patients needing urgent VKA reversal in year 1, with a 10% increase annually
- The budget impact model compares an institution that only uses FFP with one that administers KCENTRA to 100% of patients over the specified time horizon
- Projected annual savings are dependent on institution size and KCENTRA utilization
KCENTRA patients had9:
43% SHORTER LENGTH
OF STAY OVERALL
(6.7 vs 11.7 days) vs patients
treated with FFP
46% SHORTER LENGTH
OF STAY IN THE ICU
(4.3 vs 8.0 days) vs patients
treated with FFP
LOWER FREQUENCY OF DEATH
OR HOSPICE DISCHARGE
(17.9% vs 21.1%) vs patients
treated with FFP
Study Design: This retrospective analysis included over 550,000 patients treated with KCENTRA or plasma, identified from a hospital database over a 5-year period. Linked data captured diagnoses, procedures, medications, and patient demographics, enabling multivariable adjustment for age group, race, ethnicity, payor type, hospital characteristics, and geographic region. Study outcome measures included length of hospital stay, hospital costs, and frequency of death or hospice discharge.9
Some study endpoints are different from those included in the current FDA-approved labeling.
Costs were calculated using the KCENTRA budget impact model.
ICU, intensive care unit; INR, international normalized ratio; LOS, length of stay; VKA, vitamin K antagonist; WAC, wholesale acquisition cost.
*Third-party WAC listing as of December 1, 2025.
Reference: KCENTRA IDN Budget Impact Model. Available from CSL Behring as USA-KCT-0368.
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