Last reviewed · How we verify
FEIBA
At a glance
| Generic name | FEIBA |
|---|---|
| Also known as | activated prothrombin complex concentrate (aPCC) FEIBA, Anti-Inhibitor Coagulant Complex, FEIBA NF., AICC, anti-inhibitor coagulant complex |
| Sponsor | Mayo Clinic |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: EMBOLIC and THROMBOTIC EVENTS Thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events. WARNING: EMBOLIC and THROMBOTIC EVENTS See full prescribing information for complete boxed warning. Thromboembolic events have been reported during postmarketing surveill
Common side effects
- Anemia
- Diarrhea
- Hemarthrosis
- Hepatitis B surface antibody positive
- Nausea
- Vomiting
- Increase of inhibitor titer (anamnestic response)
- Chills
- Fever
- Dizziness
- Dysgeusia
- Chest pain
Serious adverse events
- Thromboembolic events
- Stroke
- Pulmonary embolism
- Deep vein thrombosis
- Hypersensitivity reactions
- Disseminated intravascular coagulation
- Tachycardia
- Flushing
Key clinical trials
- Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery (PHASE2)
- SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis (PHASE3)
- A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia (PHASE3)
- Treatment of Hemophilia A Patients With FVIII Inhibitors
- Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem
- FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR) (PHASE3)
- FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients (PHASE2)
- A Study to Evaluate the Safest Dose Range for FEIBA in Hemophilia A Patients With Inhibitors on Emicizumab (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 |