Prothrombin Complex Concentrate
Class: Hemostatics
VA Class: BL500
Brands: Kcentra
Warning
- Risk of Thromboembolism
Risk of serious, and potentially fatal arterial and venous thromboembolic events (e.g., DVT, PE, MI, disseminated intravascular coagulation [DIC]). (See Thromboembolic Complications under Cautions.)
Carefully weigh benefits of treatment against risk of thromboembolism, particularly in those with a history of a thromboembolic event.
Closely monitor for manifestations of thromboembolism during and after treatment. (See Advice to Patients.)
Carefully consider resumption of oral anticoagulant therapy as soon as risk of thromboembolism outweighs risk of bleeding.
Introduction
Hemostatic agent; preparation of nonactivated blood coagulation factors II, VII, IX, and X derived from pooled human plasma; a 4-factor prothrombin complex concentrate (PCC).
Uses for Prothrombin Complex Concentrate
Reversal of Warfarin Anticoagulation
Used for urgent reversal of vitamin K antagonist (VKA; e.g., warfarin) anticoagulation in adults with acute major bleeding or need for urgent surgery/invasive procedure; designated an orphan drug by FDA for this use.
Use in conjunction with vitamin K (phytonadione) to maintain adequate levels of coagulation factors once the effects of prothrombin complex concentrate (human) diminish.
Prothrombin complex concentrate (human) is a 4-factor PCC that rapidly restores vitamin K-dependent coagulation factors depleted by warfarin.
Experts generally consider 4-factor PCC preferable to fresh frozen plasma for urgent reversal of anticoagulation in patients with warfarin-induced major bleeding. Compared with fresh frozen plasma, 4-factor PCC is associated with more rapid INR reduction, reduced drug preparation time, reduced risk of anaphylaxis and transmission of infectious pathogens, and lower risk of volume overload.
Although fresh frozen plasma has traditionally been used for rapid reversal of VKAs in the perioperative and periprocedural settings, 4-factor PCC is recommended in current clinical practice guidelines.
When considering use of prothrombin complex concentrate (human) for reversal of VKA anticoagulation, weigh potential benefits against risk of thromboembolic complications.
Reversal of Direct Oral Anticoagulants
Has been used for reversal of direct oral anticoagulants (DOACs)† in both the setting of major bleeding and the perioperative/periprocedural setting.
Specific reversal agents (e.g., idarucizumab, coagulation factor Xa [recombinant] inactivated-zhzo [also known as andexanet alfa]) are generally recommended when DOAC reversal is needed; 4-factor PCC is suggested as an alternative when specific reversal agents not available.
Management of bleeding complications in patients receiving DOACs should be individualized according to severity and location of hemorrhage.
Most bleeding events related to DOACs can be managed with supportive measures and by withholding the a..
