- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Approves Kcentra (Prothrombin Complex Concentrate) for Urgent Reversal of Anticoagulation
Product can be administered more quickly than frozen plasma (Apr. 29)
The FDA has approved Kcentra (prothrombin complex concentrate, human; CSL Behring) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the U.S.
Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.
The product is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for patients who may not be able to tolerate the volume of plasma required to reverse VKA anticoagulation.
Kcentra is associated with the occurrence of blood clots when used as indicated and carries a boxed warning regarding the risk of blood clots. The warning also explains that patients receiving Kcentra should be monitored for signs and symptoms of thromboembolic events, as both fatal and non-fatal arterial and venous thromboembolic complications have been reported in clinical trials and in postmarketing surveillance.
Kcentra is made from the pooled plasma of healthy donors and is processed in a way to minimize the risk of transmitting viral and other diseases.
The product’s regulatory approval was based on a study of 216 patients who had been receiving VKA anticoagulation and who had acute major bleeding along with a clotting test value that indicated anticoagulant use. Kcentra was shown to be similar to plasma in terms of the ability to stop acute major bleeding in these patients.
Source: FDA; April 29, 2013.