Frequently Asked Questions about KCENTRA

For questions regarding ordering resources, reimbursement and billing, or requesting a rep visit, please contact the KCENTRA hotline 1-855-452-3687 , Mon–Fri 8 AM–8 PM ET.

For useful tools and information, download the KCENTRA Quick Guide in the Apple App Store or on Google Play .

KCENTRA is a purified, heat-treated, nanofiltered, lyophilized, non-activated 4-factor prothrombin complex concentrate (4F-PCC) made from pooled human plasma.^14,15 KCENTRA contains all 4 vitamin K–dependent coagulation factors (II, VII, IX and X), and the antithrombotic Proteins C and S.

KCENTRA is a 4F-PCC indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, such as warfarin) therapy in adult patients with:

• Need for urgent surgery or other invasive procedure or
•  Acute major bleeding

KCENTRA is for intravenous use only.

KCENTRA is manufactured using the CSL Behring Integrated Safety System, a rigorously controlled manufacturing process that is continuously monitored. All plasma used in the manufacturing of KCENTRA is obtained from prescreened US donors, and is carefully tested. A multistep pathogen inactivation and removal process, including heat treatment and virus filtration, is used to reduce the risk of transmission of infectious agents. The risk of virus transmission cannot be completely eliminated.

Patients undergoing VKA treatment experience a dose-dependent acquired deficiency of the vitamin K–dependent coagulation factors. The administration of KCENTRA for urgent warfarin reversal increases plasma levels of the vitamin K–dependent coagulation Factors II, VII, IX, and X, as well as the antithrombotic Proteins C and S.

Coagulation factors in KCENTRA are ~25 times more concentrated than in plasma, enabling factor levels to be replenished rapidly without delivering a large intravascular volume load.^14,15 Compared with fresh frozen plasma (FFP) administration, KCENTRA requires less infusion volume, allowing faster administration with comparable safety.^3,4

VKAs like warfarin act by inhibiting the synthesis of fully functional vitamin K–dependent coagulation Factors II, VII, IX, and X. Warfarin also results in a functional deficit of the antithrombotic Proteins C and S, which results in a disruption of normal hemostasis.²⁰ Currently available 3-factor PCCs contain low or variable levels of factor VII and do not include antithrombotic Proteins C and S.²¹ KCENTRA contains all 4 Vitamin–K dependent coagulation factors (II, VII, IX and X), and the antithrombotic Proteins C and S.

Unlike 3F-PCCs that are only indicated for hemophilia, KCENTRA (as a 4F-PCC) has an FDA indication for urgent warfarin reversal. KCENTRA is the only 4F-PCC indicated for urgent warfarin reversal in both adult patients who need urgent surgery/invasive procedures and those experiencing acute major bleeding. That’s in contrast to 3F-PCCs that do not carry an FDA-labeled indication of warfarin reversal.²¹

Unlike fresh frozen plasma (FFP) administration, KCENTRA replaces only those coagulation factors needed for urgent warfarin reversal.

See how KCENTRA works to replace the factors that warfarin depletes

Explore KCENTRA efficacy in head-to-head trials vs plasma

In clinical trials, infusion with KCENTRA is approximately 7 times faster than with plasma. In the Acute Major Bleeding trial, mean infusion time was 24 minutes for KCENTRA and 169 minutes for plasma. In the Urgent Surgery/Invasive Procedure trial, mean infusion time was 21 minutes for KCENTRA and 141 minutes for plasma.^3,4

Unlike fresh frozen plasma (FFP) administration, KCENTRA does not require thawing or ABO typing. KCENTRA can be stored at room temperature for up to 36 months.

If you have questions on how to reconstitute or prepare KCENTRA, please call Medical Affairs, available by phone 24/7, 1-800-504-5434, select option 1 or watch the reconstitution video .

KCENTRA demonstrated superiority over plasma in 3 of 4 efficacy endpoints in 2 head-to-head trials.^3,4

• Superior hemostatic efficacy in the Urgent Surgery/Invasive Procedures trial, and equally effective hemostatic efficacy in the Acute Major Bleeding trial
• Faster INR reduction (to ≤1.3 at 30 minutes after end of infusion) in both head-to-head trials

The administration of vitamin K is expected to maintain factor levels once the effects of KCENTRA have diminished.

The dose of vitamin K is not specified in the prescribing information. Hospitals may have their own protocols; if not, they can contact 1-800-504-5434, select option 1 or medinfona@cslbehring.com for information on vitamin K doses used in the clinical trials for KCENTRA.

KCENTRA is dosed based on units of Factor IX.

A single dose of KCENTRA is determined by the patient’s pretreatment INR and weight

• 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

Use the KCENTRA Dosage Calculator

Our Medical Affairs team is available to answer all your dosing questions.

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 (~210 units/min).

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.

Prior to Reconstitution

• KCENTRA is for single use only and contains no preservatives
• Store KCENTRA between 2–25°C (36–77°F), not to exceed 25°C (77°F). This allows room-temperature storage. Do not freeze
• KCENTRA is stable for 36 months from the date of manufacture, up to the expiration date on the carton and vial labels. Do not use beyond the expiration date on the vial label and carton
• Store the vial in the original carton to protect it from light

After Reconstitution

• The product 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

Consignment can help ensure your hospital always has the minimum adequate supply of KCENTRA for life-saving therapy, while supporting more efficient management of inventory and resources. Work with your distributor to learn more about consignment. As always, CSL representatives are available to assist you and address any concerns you may have with ordering on consignment.

CSL Behring is committed to saving lives and improving lives of people with rare and serious diseases. This commitment is reflected in our history as a leader in coagulation therapies.

CSL Behring is committed to maintaining the highest standards of quality and safety of manufacturing and marketing a range of plasma-derived and recombinant therapies worldwide.

Our integrated safety system and extensive quality control measures ensure that only the highest quality plasma is selected for use in manufacturing and only safe and effective therapies are released.

To learn more, visit cslbehring.com.au/our-company/the-csl-behring-commitment

KCENTRA representatives are happy to find a time that works with your schedule.