Safety profile of Kcentra is comparable to plasma

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Adverse reactions of Kcentra and plasma were evaluated in 2 head-to-head trials

Adverse reactions reported in more than 5 subjects (≥2.8%) following Kcentra or plasma administration in both randomized, controlled trials.
Adverse reactions reported in more than 5 subjects (≥2.8%) following Kcentra or plasma administration in both randomized, controlled trials
Adverse reactions No. (%) of subjects
Kcentra (N=191) Plasma (N=197)
Nervous system disorders
Headache 14 (7.3%) 7 (3.6%)
Respiratory, thoracic, and mediastinal disorders
Pleural effusion 8 (4.2%) 3 (1.5%)
Respiratory distress​/​dyspnea​/​hypoxia 7 (3.7%) 10 (5.1%)
Pulmonary edema 3 (1.6%) 10 (5.1%)
Gastrointestinal disorders
Nausea/vomiting 12 (6.3%) 8 (4.1%)
Diarrhea 4 (2.1%) 7 (3.6%)
Cardiac disorders
Tachycardia 9 (4.7%) 2 (1.0%)
Atrial fibrillation 8 (4.2%) 6 (3.0%)
Metabolism and nutrition disorders
Fluid overload* 5 (2.6%) 16 (8.1%)
Hypokalemia 9 (4.7%) 14 (7.1%)
Psychiatric disorders
Insomnia 9 (4.7%) 6 (3.0%)
Vascular disorders
Hypotension 14 (7.3%) 10 (5.1%)
Injury, poisoning, and procedural complications
Skin laceration​/​contusion​/​subcutaneous hematoma 8 (4.2%) 5 (2.5%)
Blood and lymphatic disorders
Anemia 11 (5.8%) 16 (8.1%)

*Includes fluid overload and cardiac failure congestive.

Includes orthostatic hypotension, hypotension, and hemorrhagic shock.

Includes anemia, hemoglobin decreased, and hematocrit decreased.

Kcentra did not increase the risk of thromboembolic (TE) events vs plasma

TE events, fluid overload events, and deaths.
Serious events occurring in both RCTs
Serious adverse reactions No. (%) of subjects
Kcentra (N=191) Plasma (N=197)
TE events* 13 (6.8%) 14 (7.1%)
Fluid overload events 9 (4.7%) 25 (12.7%)
Deaths 13 (6.8%) 13 (6.6%)

*Includes deep-vein thrombosis, thrombosis, ischemic stroke, vena cava filter insertion, catheter-related complication, acute myocardial infarction, pulmonary embolism, and transient ischemic attack.1

Includes fluid overload and cardiac failure congestive.

  • One death in the Kcentra group was considered possibly related to study treatment in the Acute Major Bleeding trial
  • One death in the plasma group was considered possibly related to study treatment in the Urgent Surgery/Invasive Procedures trial
  • No factors common to all deaths were identified, except the frequent findings of high comorbidity burden, advanced age, and death after being placed on comfort care
  • Outliers with supraphysiologic factor levels did not have a mortality rate out of proportion to the overall population
  • Patients were monitored for serious adverse reactions, including TE events, for 45 days postinfusion

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events.

Patients being treated with vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events.

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.

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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