Last reviewed · How we verify
Beriplex® P/N (Kcentra)
Beriplex P/N is a prothrombin complex concentrate that replaces deficient vitamin K-dependent clotting factors to rapidly reverse warfarin anticoagulation.
Beriplex P/N is a prothrombin complex concentrate that replaces deficient vitamin K-dependent clotting factors to rapidly reverse warfarin anticoagulation. Used for Urgent reversal of warfarin anticoagulation in patients with life-threatening bleeding, Reversal of warfarin anticoagulation in patients requiring emergency surgery or urgent procedures.
At a glance
| Generic name | Beriplex® P/N (Kcentra) |
|---|---|
| Also known as | Kcentra |
| Sponsor | CSL Behring |
| Drug class | Prothrombin complex concentrate (PCC) |
| Target | Vitamin K-dependent clotting factors (Factors II, VII, IX, X) |
| Modality | Biologic |
| Therapeutic area | Hematology / Anticoagulation reversal |
| Phase | Phase 3 |
Mechanism of action
Beriplex P/N contains concentrated human plasma-derived clotting factors II, VII, IX, and X (the vitamin K-dependent factors). It is used to quickly restore coagulation capacity in patients who are over-anticoagulated with warfarin and require urgent reversal, such as in cases of life-threatening bleeding or before emergency surgery. The product works by directly replenishing the depleted clotting factors that warfarin inhibits.
Approved indications
- Urgent reversal of warfarin anticoagulation in patients with life-threatening bleeding
- Reversal of warfarin anticoagulation in patients requiring emergency surgery or urgent procedures
Common side effects
- Thromboembolism (venous thromboembolism, myocardial infarction, stroke)
- Hypersensitivity reactions
- Disseminated intravascular coagulation (DIC)
- Headache
- Nausea
Key clinical trials
- Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk. (PHASE3)
- An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure (PHASE3)
- Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Beriplex® P/N (Kcentra) CI brief — competitive landscape report
- Beriplex® P/N (Kcentra) updates RSS · CI watch RSS
- CSL Behring portfolio CI