KCENTRA Quick Guide 1.13

The following information pertains to the Kcentra® application, including critical safety alerts and features.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients undergoing Vitamin K antagonist therapy may be at risk for thromboembolic events due to underlying conditions. It is essential to assess the potential advantages of reversing VKA in relation to the risk of such events, particularly in individuals with a history of thromboembolic incidents. Consideration should be given to the resumption of anticoagulation therapy when the risk of thromboembolic events exceeds that of acute bleeding. Clinical trials and post-marketing surveillance have documented both fatal and nonfatal thromboembolic complications. Continuous patient monitoring during Kcentra administration is recommended, along with education regarding the signs and symptoms of thromboembolic events. Notably, Kcentra has not been evaluated in patients who experienced a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebrovascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the past three months. Therefore, its use in such patients may not be appropriate.

Kcentra is contraindicated in individuals with a history of anaphylaxis 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. Additionally, it is contraindicated for patients diagnosed with disseminated intravascular coagulation or heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions may occur following Kcentra administration. In cases of severe allergic or anaphylactic reactions, it is crucial to discontinue treatment immediately and provide suitable medical care.

In clinical evaluations, the most frequently reported adverse reactions (≥2.8%) associated with Kcentra included headache, nausea/vomiting, hypotension, and anemia. The most serious adverse effects noted were thromboembolic events such as stroke, pulmonary embolism, and deep vein thrombosis.

Kcentra is derived from human blood products and carries a potential risk for transmitting infectious agents, including viruses and prions that may cause variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD).

Kcentra®, Prothrombin Complex Concentrate (Human), is specifically indicated for the urgent reversal of acquired coagulation factor deficiency due to Vitamin K antagonist (VKA—e.g., warfarin) therapy in adult patients experiencing acute major bleeding or requiring urgent surgery or other invasive procedures. This product is intended for intravenous use only.

Kcentra App Features:

• Dosing calculator and guidelines
• Reconstitution instructional video and step-by-step guide
• Administration guidelines
• Patient monitoring information
• Customer support contact details
• Product reimbursement information
• Comprehensive product overview
• Notification center for updates
• Personal bookmarking system for ease of access

For full Prescribing Information and Important Safety Information, including boxed warnings, please visit www.Kcentra.com.