Feiba (anti-inhibitor coagulant complex) / Takeda - LARVOL DELTA

Bigger is not Alway Better: A Case of Extensive Thrombus Formation After MAC placement for Heart Transplant Due to Complicated Congenital Heart Disease (ASA 2025) - "Transplant was complicated by massive hemorrhage from collaterals requiring resuscitation via MAC with PA catheter and use of FEIBA and Factor VII concentrate. During post-operative PICC line placement IR noted thrombosis of left SVC and brachiocephalic veins requiring clot evacuation. This was complicated by hemodynamic collapse on induction with successful resuscitation."

Clinical • Cardiovascular • Heart Failure • Hematological Disorders • Thrombosis • Transplantation

SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis (clinicaltrials.gov) - P3 | N=5 | Recruiting | Sponsor: Emory University | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: Northwell Health

New P2 trial • Cardiovascular • Heart Failure

Acquired Haemophilia A: Current Treatment and Outcomes in New South Wales Australia (ISTH 2025) - "Initial management included steroids (n=29), rVIIa (n=18), FEIBA (n=7), porcine factor VIII (n=1), IVIg (n=8), rituximab (n=20), cyclophosphamide (n=10), and emicizumab (n=5). Other additional agents at rebleed, new bleed or relapse included ciclosporin, daratumumab and mycophenolate mofetil...There were 7 cases of death related to AHA or treatment. Table or Figure Upload"

Diabetes • Hematological Disorders • Hemophilia • Hemophilia A • Infectious Disease • Neutropenia • Novel Coronavirus Disease • Rare Diseases

Efficacy and safety of emicizumab in real clinical practice: results from a national study (ISTH 2025) - "Aims Analysis of data on the efficacy and safety of emcizumab in real clinical practice in the Republic of Serbia. Our data indicate that emicizumab is highly effective in real clinical practice, comparable to the results from registration clinical studies. However, the risk of arterial thrombosis should be carefully considered. Methods We retrospectively analyzed data for all adult patients treated with emicizumab in the Republic of Serbia and calculated the annualized bleeding rate before and after the start of emicizumab prophylaxis for those patients who received emicizumab for at least 6 months."

Clinical • Cardiovascular • Hematological Disorders • Hemophilia • Hemophilia A • Myocardial Infarction • Rare Diseases • Thrombosis

Thrombin Generation after FEIBA administration measured with the EnzySystem for hemophilia A (ISTH 2025) - "Aims Assess the EnzySystem’s capability in monitoring the in vivo effect of FEIBA in PWHAI Background Monitoring the effect of bypassing agents in people with hemophilia A with inhibitors (PWHAI) is challenging. The FVIIIa activity assay, which was performed simultaneously by design, showed high signals only in the patients receiving emicizumab. Table or Figure Upload"

Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Intraoperative Hemostatic Agents in Thoracic Aortic Surgery-A Scoping Review. (PubMed, J Clin Med) - "Two small RCTs-one on TXA, one on aprotinin-suggest reduced transfusions and blood loss. Small studies suggest potential for the routine use of antifibrinolytics, FEIBA, and fibrinogen supplementation-but only in bleeding patients with hypofibrinogenemia. High-quality RCTs focused on thoracic aortic procedures are needed to determine optimal coagulation management."

Journal • Review • Cardiovascular

Bleeding Complications, Transfusion, and Acute Care Costs After Major Arthroplasty in Patients With Hereditary Bleeding Disorders: A National Healthcare Database Analysis. (PubMed, Anesth Analg) - "THA and TKA in patients with hereditary BDs are relatively safe, with most outcomes comparable to controls. However, higher rates of bleeding, transfusion, and VTE underscore the need for optimizing anemia management and targeted use of CFCs along with antifibrinolytic therapy."

Journal • Cardiovascular • Hematological Disorders • Orthopedics • Pain • Venous Thromboembolism

SAFE Study: Safety of APCC Following Emicizumab Prophylaxis (clinicaltrials.gov) - P3 | N=5 | Recruiting | Sponsor: Emory University | N=20 ➔ 5

Enrollment change • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Successful Urgent Liver Transplantation in a High-Risk Patient on Therapeutic Apixaban: A Complex Case of End-Stage Liver Disease and Hepatocellular Carcinoma with Portal Vein Thrombosis (IARS-SOCCA 2025) - "Their suggestion was low molecular weight heparin as first line and vitamin K antagonists (Warfarin) be used as second line...Given apixaban use and the patient's ESLD and CKD3b, a multidisciplinary team discussed apixaban reversal with anti-inhibitor coagulant complex (FEIBA) vs prothrombin complex concentrate [human] (Kcentra); our institution has removed the FDA approved reversal agent for Xa inhibitors (recombinant Factor Xa) from formulary...Once the portal clamp was removed, one gram of tranexamic acid was administered...This case highlights the complexities of managing therapeutic anticoagulation with apixaban in urgent LT. Patients with ESLD are at high risk for any major surgery due to significant coagulopathy; however, in the setting of liver transplantation, a fine balance exists. In the prehepatic and anhepatic phases, it is important to minimize blood loss from the surgical perspective as well as adequately resuscitate without exacerbating venous..."

Clinical • Anesthesia • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Hepatitis C • Hepatocellular Cancer • Hepatology • Hypertension • Hypotension • Infectious Disease • Ischemic stroke • Nephrology • Oncology • Solid Tumor • Thrombosis • Transplantation • Venous Thromboembolism

Spontaneous hemorrhage arising from a proximal descending branch of the suprascapular artery. (PubMed, Am J Emerg Med) - "There are no prior case reports of spontaneous suprascapular artery hemorrhage, though rupture secondary to an inciting traumatic event has been described. This case highlights the importance of maintaining a high index of suspicion for vascular injury in patients with an enlarging soft tissue mass, as early diagnosis and intervention are crucial for achieving a favorable outcome."

Journal • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Peripheral Arterial Disease

RARE CASE OF ACQUIRED CLOTTING FACTOR INHIBITOR FROM BLADDER CANCER (SCCM 2025) - "He received 7units of FFP, 2PRBC, Vitamin-K and KCENTRA over the first few days but hematuria and coagulopathy did not improve...He was started on steroids and Factor eight inhibitor bypass activity (FEIBA) treatment for ACFI...Treatment is 3 prong; 1) correct coagulopathy 2) replenish blood loss 3) stabilize/treat immune dyscrasia. Factor V inhibitors are rare but may arise from exposure to topical fibrin glues or bovine thrombin preparations that contain bovine factor V. Early recognition, confirmation and therapy initiation of ACFI is key to ensuring positive outcome and to avoid complications from life threatening bleed"

Clinical • Bladder Cancer • Cardiovascular • Genito-urinary Cancer • Hematological Disorders • Hematological Malignancies • Hypertension • Immunology • Lung Cancer • Mood Disorders • Oncology • Rheumatology • Solid Tumor • Urology

COMPARISON OF TWO DIFFERENT FIXED-DOSE FACTOR EIGHT INHIBITOR BYPASSING ACTIVITY (FEIBA) REGIMENS IN THE MANAGEMENT OF WARFARIN-ASSOCIATED COAGULOPATHIES. (WRMC 2025) - "Kcentra is the only FDA approved PCC for managing warfarin associated coagulopathies, but Factor VIII Inhibitor Bypass Activity (FEIBA) is commonly used in its place. Conclusions Our new FEIBA dosing recommendations resulted in more individuals achieving the post-FEIBA administration INR goal. Authors plan to finalize data collection and analysis in the coming months."

Cardiovascular

Clinical and Economic Outcome Analysis of First-Line Immunosuppression in Acquired Hemophilia a (ASH 2024) - "Bypassing agents, rFVIIa and FEIBA, comprised 94% of the hemostatic treatment costs...Those treated with steroids and rituximab (B) had the lowest frequency of relapse, and lower incidence of infection and non-infection grade 3/4 AE than regimens containing cyclophosphamide. To our knowledge, this is the first study to evaluate the comprehensive economic burden of AHA treatment. Overall, the majority of costs were from hemostatic treatments, not from IST, and differences between regimens may be due to proportions of high risk patients and the frequency and severity of bleeding events."

Clinical • HEOR • Hematological Disorders • Hemophilia • Hemophilia A • Infectious Disease • Neutropenia • Rare Diseases

4-Factor prothrombin complex concentrates and factor VIII inhibitor bypass activity use in cardiac surgery. (PubMed, Blood Coagul Fibrinolysis) - "Among cardiac surgery patients, there was no difference in thromboembolic events between patients who received 4F-PCC or FEIBA when used as an adjunct to blood product administration."

Journal • Surgery • Acute Kidney Injury • Cardiovascular • Critical care • Hematological Disorders • Myocardial Infarction • Nephrology • Pulmonary Embolism • Renal Disease • Respiratory Diseases

Comparison of Drugs Used for Prophylaxis in Hemophilia a or B with Inhibitors: A Systematic Review and Frequentist Network Meta-Analysis of Randomized Clinical Trials (ASH 2024) - "NMA was registered on PROSPERO CRD42024532136.Results : In 6 RCTs (N=457), 38 patients were treated with fitusiran prophylaxis, 114 patients with concizumab prophylaxis, 147 patients with emicizumab prophylaxis, 17 patients with FEIBA NF prophylaxis, 26 patients with AICC prophylaxis, and 115 patients were only treated on demand without prophylaxis. Emicizumab and fitusiran had higher efficacy as compared to other prophylactic agents in hemophilia. More large-scale randomized head-to-head comparisons are needed to confirm these results."

Retrospective data • Review • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Evaluation of AntiInhibitor Coagulant Complex Usage Relative to Health System Guidelines and Current Clinical Practices (ASHP 2024) - No abstract available

Clinical

Evaluation of Factor Eight Inhibitor Bypassing Activity FEIBA Administration for the Reversal of Direct Oral Anticoagulants DOACs in Patients at a Community Hospital (ASHP 2024) - No abstract available

Clinical

Acquired Hemophilia A as a Cause of Obscure Gastrointestinal Bleeding (ACG 2024) - "We present a case of a patient with acute blood loss anemia with recurrent GI bleeding despite multiple unrevealing endoscopic evaluations, ultimately found to have Acquired Hemophilia A. Case Description/ An 89-year-old male with a history of atrial fibrillation on apixaban and psoriatic arthritis presented to the hospital with multiple episodes of dark stool and hemoglobin of 5.9 g/dL on outpatient labs...The patient was found to have unusually low factor VIII activity at 6% and a positive Factor VIII inhibitor at 25.6, concerning for acquired hemophilia A. He was transferred to an outside facility for recombinant human factor VIIa but eventually transitioned to anti-inhibitor coagulant complex (aPCC) due to persistently elevated PTT and continued bleeding. He was also given high dose steroids and rituximab for inhibitor eradication...Recognizing AHA in patients with unexplained recurrent bleeding is crucial, as treatment with bypass agents like recombinant factor VIIa..."

Anemia • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Hemophilia • Hemophilia A • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rare Diseases • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies

A Case of Acute Gastrointestinal Bleeding Secondary to Acquired Hemophilia A (ACG 2024) - "She underwent esophagogastroduodenoscopy (EGD) and colonoscopy (CSC) to find the etiology of persistent diarrhea despite conservative management and holding metformin...Treatment should be targeted at achieving hemostasis with a bypassing agent such as recombinant activated factor VII (rFVIIa) or Factor VIII Inhibitor Bypassing Agent (FEIBA). corticosteroids alone or combined with cyclophosphamide can be used for immunosuppression. Rituximab has been used with success as well."

Clinical • Cardiovascular • Diabetes • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hemophilia • Hemophilia A • Hypertension • Metabolic Disorders • Mood Disorders • Psychiatry • Rare Diseases • Type 2 Diabetes Mellitus

THE CLOTTING CONUNDRUM: FATAL RECURRENT HEMATOMAS IN A CRITICALLY ILL PATIENT - A RARE CARE OF ACQUIRED HEMOPHILIA (CHEST 2024) - "Apixaban was thereby discontinued...Early indicators of the disease are non-traumatic bleeding/ecchymosis, mucosal bleeding, post-operative bleeding, retroperitoneal bleeding, etc. Presentation varies from mild to severe, and can turn fatal despite appropriate management with FEIBA and rFVIIa similar to our case. Additional options include steroids and immunomodulators like cyclophosphamide and rituximab. This case emphasizes the importance of prompt workup of prolonged PTT to clinch the diagnosis of acquired hemophilia in patients with life threatening bleeding that is otherwise unexplained."

Clinical • Gastrointestinal Disorder • Hematological Disorders • Hemophilia • Hemophilia A • Immunology • Pain • Rare Diseases

Factor Eight Inhibitor Bypass Activity use in cardiac surgery: A propensity matched analysis of safety outcomes. (PubMed, Anesthesiology) - "Low dose FEIBA administration during cardiac surgery does not increase risk of thromboembolic events, ICU LOS, or mortality in a propensity matched cohort. Higher doses were associated with increased acute renal failure and postoperative transfusion. Further studies are required to establish the efficacy of activated factor concentrates to treat refractory bleeding during cardiac surgery."

Journal • Surgery • Acute Kidney Injury • Cardiovascular • Hematological Disorders • Ischemic stroke • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Venous Thromboembolism

FEIBA: Too Potent a Potion or Just Right for Post-CPB Bleeding? (PubMed, J Cardiothorac Vasc Anesth) - No abstract available

Journal

Perils of a 3-mm punch biopsy (BAD 2024) - "Her medical background was significant for invasive cholangiocarcinoma and she was on active treatment with gemcitabine under the care of oncology...The patient was discussed with haematology, and tranexamic acid for 3 days was recommended and aspirin was held...She was commenced on prophylactic FEIBA (anti-inhibitor coagulant complex) intravenous three times per week...It is more frequent in older patients and is associated with several conditions such as malignancies, the postpartum period, autoimmune diseases and drug exposure. This is a rare presentation; however, it highlights the risks involved with even minor dermatological surgical procedures and the importance of consenting patients for these possible complications."

Biopsy • Biliary Cancer • Cholangiocarcinoma • Dermatology • Gastrointestinal Cancer • Hematological Disorders • Hemophilia • Immunology • Oncology • Rare Diseases • Solid Tumor

Factor Eight Inhibitor Bypassing Activity as First-line Therapy for Coagulopathy in Cardiac Surgery. (PubMed, J Cardiothorac Vasc Anesth) - "In the initial treatment of postcardiopulmonary bypass coagulopathy, FEIBA may be more effective than FFP in decreasing blood product transfusions and readmission rates. Further studies are needed to explore the potential routine use of FEIBA as first-line agent in this patient population."

Journal • Surgery • Cardiovascular • Critical care • Hematological Disorders