Prothrombin Complex Concentrate (Human) [(Factors II, VII, IX, X), Protein C, and Protein S]

~6 to 8 hours

Half-Life Elimination

Factor II: 48 to 60 hours; Factor VII: 1.5 to 6 hours; Factor IX: 20 to 24 hours; Factor X: 24 to 48 hours; Protein C: 1.5 to 6 hours; Protein S: 24 to 48 hours

Note: Half-lives may be significantly reduced in severe hepatocellular damage, DIC, or extended catabolic metabolism.

Life-threatening bleeding associated with non-vitamin K antagonist anticoagulants

Based on the Updated European Heart Rhythm Association Practical Guide on the Use of Non-vitamin K Antagonist Anticoagulants in Patients with Non-valvular Atrial Fibrillation and the American Heart Association/American Stroke Association (AHA/ASA) Guidelines for the Management of Spontaneous Intracerebral Hemorrhage, the use of prothrombin complex concentrate (human) (ie, 4-factor PCC) may be considered for the treatment of life-threatening bleeding associated with dabigatran (if idarucizumab is not available) or oral direct factor Xa inhibitors (eg, apixaban, edoxaban, or rivaroxaban) if it is readily available in the hospital.

More recently, the Neurocritical Care Society and Society of Critical Care Medicine guidelines for the reversal of antithrombotics in intracranial hemorrhage suggests the use of either 4-factor PCC or anti-inhibitor coagulant complex (human) (ie, activated PCC) for patients with intracranial hemorrhage associated with dabigatran (if idarucizumab is unavailable) or oral direct factor Xa inhibitors (eg, apixaban, edoxaban, or rivaroxaban) if intracranial hemorrhage occurred within 3 to 5 terminal half-lives of drug exposure or if liver failure exists.

Octaplex [Canadian product]: Adolescents ≥17 years: Refer to adult dosing.

Kcentra, Beriplex [Canadian product]: In patients weighing >100 kg; do not exceed maximum dose recommended according to pretreatment INR.

Octaplex [Canadian product]: There are no dosage adjustments provided in the manufacturer’s labeling.

Prior to reconstitution, allow diluent (SWFI) and prothrombin complex concentrate (PCC) vials to warm to room temperature. Aseptically push the plastic spike at the blue end of the Mix2Vial transfer set through the center of the stopper of the diluent vial. After carefully removing only the clear package from the Mix2Vial transfer set, invert the diluent vial with the transfer set still attached and push the plastic spike through the center of the stopper of PCC vial; diluent will automatically transfer. While still attached, gently swirl PCC vial to ensure product is dissolved; do not shake. Disconnect the 2 vials; contents of PCC vial are now available for removal by screwing a syringe onto the transfer set. Inject appropriate amount of air into vial, invert vial, and withdraw amount needed. Remove syringe from transfer set and attach an administration set to the syringe.

Note: Kcentra vials may contain differing amounts of factor IX units per vial. The exact amount of factor IX units in each vial should be used when calculating and preparing the total dose to be administered. Overdosage errors have occurred when the dose has been improperly calculated. (ISMP 2014)

Kcentra, Beriplex P/N [Canadian product]: Store at 2°C to 25°C (36°F to 77°F); do not freeze. Protect from light. Reconstituted product may be stored at 2°C to 25°C (36°F to 77°F) and used within 4 hours (Kcentra) or 3 hours (Beriplex P/N) following reconstitution. If cooled, warm to 20°C to 25°C (68°F to 77°F) prior to administration.

Octaplex [Canadian product]: Store at 2°C to 25°C (36°F to 77°F); do not freeze. Protect from light. Reconstituted solution should be administered immediately, but may be stored for up to 8 hours at 2°C to 25°C (36°F to 77°F) if sterility is maintained.

There are no known significant interactions.

INR (baseline and at 30 minutes post dose); clinical response during and after treatment; signs of thromboembolism