Risks of Beriplex (Prothrombin Complex Concentrate)
The primary risk of Beriplex is thrombosis, and it should be avoided in patients with hemophilia A and B, particularly those with bleeding disorders, as current guidelines explicitly recommend against its use in this population. 1
Key Safety Concerns
Thrombotic Risk
- The International Society on Thrombosis and Haemostasis explicitly states that prothrombin complex concentrates increase the risk of thrombosis and should not be used for treating hemophilia. 1
- Thrombotic events occurred at approximately 4 per 100,000 infusions in post-market surveillance, with most events occurring when dosing recommendations were exceeded. 2
- One documented fatal thrombotic stroke occurred 48 hours after Beriplex administration in a patient with severe peripheral vascular disease, sepsis, and multi-organ failure. 3
- Over 80% of patients experiencing thrombotic events had pre-existing cardiovascular risk factors. 2
Coagulation Activation
- Beriplex significantly increases prothrombin fragment F1+2 levels, indicating in vivo activation of the coagulation cascade through factor Xa-mediated prothrombin cleavage. 4
- Plasma fibrinopeptide A levels rise significantly after PCC administration, demonstrating thrombin generation and enzymatic activity on fibrinogen. 4
- These markers of coagulation activation are substantially higher with prothrombin complex concentrates compared to purified factor IX concentrates. 4
High-Risk Patient Populations
Exercise extreme caution or avoid Beriplex entirely in patients with: 3
- Disseminated intravascular coagulation
- Active sepsis
- Liver disease
- Pre-existing antithrombin deficiency (present in 43% of patients in one study) 3
- Peripheral vascular disease
- Renal or cardiac failure
Appropriate Use Context
Warfarin Reversal (Not Hemophilia)
- Beriplex effectively reverses warfarin anticoagulation, achieving immediate INR normalization in virtually all patients within 20 minutes. 3
- In warfarin reversal for life-threatening bleeding, Beriplex demonstrated 77.8% achievement of partial or complete hemostasis. 5
- Most patients (83.3%) required no more than 1500 IU for effective reversal. 5
Critical Clinical Pitfall
Do not use Beriplex or any prothrombin complex concentrate for treating bleeding in hemophilia A or B patients. 1, 6 The 2024 ISTH guidelines explicitly exclude PCCs from treatment recommendations due to thrombotic risk, recommending instead:
- Recombinant factor VIII or IX concentrates for hemophilia without inhibitors 6
- Recombinant factor VIIa or activated prothrombin complex concentrate (not standard PCC) for hemophilia with inhibitors 1, 6
- Emicizumab for prophylaxis in hemophilia A with inhibitors 6
Monitoring Requirements
When Beriplex must be used (e.g., warfarin reversal), monitor: 3
- INR at baseline, 20,60, and 120 minutes post-administration
- Antithrombin levels (may decrease further in already-deficient patients)
- D-dimer and fibrinogen for DIC screening
- Platelet count
- Clinical signs of thromboembolism for at least 7 days post-administration