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aPCC, aPCC + TXA
aPCC (activated prothrombin complex concentrate) restores coagulation by providing vitamin K-dependent clotting factors, and when combined with TXA (tranexamic acid), is further enhanced by inhibiting fibrinolysis to reduce bleeding.
aPCC (activated prothrombin complex concentrate) restores coagulation by providing vitamin K-dependent clotting factors, and when combined with TXA (tranexamic acid), is further enhanced by inhibiting fibrinolysis to reduce bleeding. Used for Life-threatening bleeding in patients with factor deficiencies or warfarin/anticoagulant reversal, Perioperative hemostasis management in high-risk bleeding scenarios.
At a glance
| Generic name | aPCC, aPCC + TXA |
|---|---|
| Also known as | Feiba i.v, Feiba i.v + Cyklokapron |
| Sponsor | Oslo University Hospital |
| Drug class | Prothrombin complex concentrate with antifibrinolytic agent |
| Target | Vitamin K-dependent clotting factors (II, VII, IX, X); plasminogen |
| Modality | Small molecule |
| Therapeutic area | Hematology / Hemostasis |
| Phase | FDA-approved |
Mechanism of action
aPCC contains activated forms of factors II, VII, IX, and X that bypass deficient or inhibited factors in the coagulation cascade, restoring thrombin generation. The addition of tranexamic acid, a plasminogen inhibitor, prevents excessive fibrin breakdown and stabilizes clots, creating a synergistic hemostatic effect. This combination is used to manage life-threatening bleeding in patients with factor deficiencies or anticoagulant reversal needs.
Approved indications
- Life-threatening bleeding in patients with factor deficiencies or warfarin/anticoagulant reversal
- Perioperative hemostasis management in high-risk bleeding scenarios
Common side effects
- Thromboembolism (venous thromboembolism, myocardial infarction)
- Disseminated intravascular coagulation (DIC)
- Allergic reactions
- Headache
Key clinical trials
- A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants (PHASE1)
- A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor (PHASE4)
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:
- aPCC, aPCC + TXA CI brief — competitive landscape report
- aPCC, aPCC + TXA updates RSS · CI watch RSS
- Oslo University Hospital portfolio CI