Safety profile of Kcentra is comparable to plasma
Adverse reactions of Kcentra and plasma were evaluated in 2 head-to-head 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
| 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.
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.
