12/4/2017 Kcentra ®

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Prothrombin Complex Concentrate (Human) Important Safety Information

Kcentra is the First and Only Non-Activated 4-Factor Prothrombin Complex Concentrate (4F-PCC) for Urgent Reversal.

Kcentra is indicated for the urgent reversal of acquired factor deficiency induced by Vitamin K antagonist (VKA, such as warfarin) therapy in adult patients with: acute major bleeding need for urgent surgery or other invasive procedure

Kcentra is for intravenous use only.

Visit www.kcentra.com to learn more.

Diagnostic Codes (ICD-10-CM)

ICD-10-CM Codes Used to identify patient medical conditions (for claims with a date of service on or after October 1, 2015)

Code Description

30283B1 Transfusion of Nonautologous 4-Factor Prothrombin Complex Concentrate into Vein, Percutaneous Approach

Billing Codes (HCPCS, NDC, CPT)

HCPCS Codes The following HCPCS codes describe supplies (including drugs) rendered by the billing provider. CMS publishes and maintains the HCPCS code set. These codes are entered to paper claim form CMS-1500 in Field 24; or, to electronic claim form ASC 837P in Loop 2400, Segment SV101-2, with the Qualifier "HC" entered to Segment SV101-1, unless otherwise directed by the payor.

Code Description

C9132 PROTHROMBIN COMPLEX CONCENTRATE (HUMAN), KCENTRA, PER I.U. OF FACTOR IX ACTIVITY

NDC Codes Certain payors may require the entry of NDC information to the claim form, as directed by the payor.

Amount per vial NDC Number

500 IU 63833-0386-02

1000 IU 63833-0387-02

CPT Codes If the billing provider performs administration services in conjunction with a patient's infusion, the following administration codes may be used to bill for this service if the service meets the requirements of the code description.

Code Description

96365 Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour

96366 Each additional hour

96374 Intravenous push, single or initial substance/drug

96376 Each additional sequential intravenous push of the same substance/drug provided in a facility

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Authorized Distributors

Companies

ASD Healthcare/AmeriSourceBergen

BDI Pharma

BioCare

Cardinal Health Specialty Pharmaceutical Distribution

FFF Enterprises

HMPG Pharmacy LLC

McKesson Plasma & Biologicals LLC

National Hospital Specialties

Safety Data Sheets

Safety Data Sheets (SDS) for Kcentra.

Important Safety Information for Kcentra

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, 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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