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

Evaluating reversal strategies for long-acting factor XI antibodies: RFVIIa®, FEIBA®, Kcentra®, novel FXI mutants, and an anti-idiotypic antibody (ASH 2025) - "BAY1831865), and theactive site binding FXIa inhibitor osocimab...With contact activation (ellagic acid or kaolin), the relative potency of thrombin inhibitionshifted: AB011 again showed the strongest inhibition on par with FXI-/- plasma, followed by gruticibart,and osocimab... FXI inhibitors produce anticoagulant effects across global coagulation assays that can bepartially or completely reversed by bypassing agents, particularly NovoSeven® and FEIBA®; however PT,TGA and viscoelastic testing also reveal the potential to generate a transient procoagulant/prothromboticstate if plasma concentrations of these commercially available agents are too high. The magnitude of theprocoagulant activity is dependent on the bypassing agent as well as the specific FXI inhibitor, suggestingthat reversal strategies should be tailored to the mechanism of the different FXI inhibitors (i.e. A2, A3, orcatalytic domain) to achieve optimal outcomes."

Hematological Disorders • Hemophilia • Rare Diseases

The Mayo Clinic enterprise experience and outcomes of perioperative utilization of recombinant factor VIIa (rFVIIa, NovoSeven®) (ASH 2025) - "Adjunctive medications to control bleeding included emicizumab, FEIBA, and rituximab.Mean estimated blood loss was 136 mL (SD 211 mL), and mean length of stay was 5.7 days (SD 6.4).Surgical risk strongly correlated with perioperative outcomes: blood loss increased from 19 mL in verylow-risk surgeries to 352 mL in very high-risk surgeries, while mean length of stay increased from 4.5days (risk 1) to 19 days (risk 4) and 11 days (risk 5).Actual rFVIIa dosing ranged from 7.2 to 7211.5 mcg/kg per dose, with a median of 67.4 mcg/kg and amean of 852.8 mcg/kg, reflecting variability in clinical practice. In conclusion, perioperative rFVIIa was most frequently used for Factor VII deficiency but was alsoadministered to patients with Factor VIII inhibitor and Glanzmann's thrombasthenia, as well as severalrare congenital and acquired bleeding disorders. Postoperative thrombotic events were rare, while ISTH-defined bleeding complications and readmissions were common. Most..."

Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Lower dose emicizumab prophylaxis in children with hemophilia A: Real - world outcomes , hemostatic profiles and cost- effectiveness from a resource limited setting (ASH 2025) - "Evidence on lower dose Emicizumabin real-world pediatric cohorts is limited.Objective:To assess clinical outcomes, thromboelastography (TEG) profiles, and cost-effectiveness in childrenreceiving lower dose Emicizumab compared to prior treatment regimens.This was a hybrid observational study comprising a retrospective clinical audit and a prospectivelydesigned laboratory substudy, conducted at a single tertiary care center in India of children with severeHemophilia A who initiated lower-dose Emicizumab prophylaxis between June 2019 and May 2024.Eighteen pediatric patients were included: 15 without inhibitors (on low- to intermediate-dose clottingfactor concentrate [CFC] prophylaxis) and 3 with inhibitors (previously on FEIBA on demand).Clinical Outcomes:Annualized bleed rates (ABR) and school absenteeism (days/year) were recorded for one year pre- andpost-Emicizumab. Lower dose Emicizumab significantly reduces bleeding and school absenteeism in children withHemophilia A,..."

Clinical • Cost effectiveness • Hematological Disorders • Hemophilia • Hemophilia A • Mood Disorders • Rare Diseases

Acquired hemophilia a results from a provincial registry highlight the need for improvement of clinical outcomes and bypassing agent use (ASH 2025) - "In total, 37 patients (93%) received some form of IST, with allcases initiated on steroids at diagnosis, 25 also receiving cyclophosphamide, and 12 receiving rituximabat a median of 5 weeks after starting IST (range 1–36)...FEIBAwas used in 53% of cases (median 44947 IU, range 0 – 278358 IU), recombinant factor VIIa in 70%(median 228 mg, range: 0 – 1522 mg), and recombinant porcine FVIII in 24% (median 10275 IU, range 0–96486 IU)...The AHA registry includes 40 cases from 2018 through 2024, inclusive. Median age was 75 years (range41-92) and 62.5% were male. At diagnosis the mean inhibitor titer was 109 Bethesda units (BU) with halfof patients presenting with inhibitor titer > 20 BU."

Clinical • Clinical data • Cardiovascular • Gastroenterology • Hemophilia • Hemophilia A • Rare Diseases • Solid Tumor • Thrombosis

SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis (clinicaltrials.gov) - P3 | N=5 | Recruiting | Sponsor: Emory University | Trial completion date: Sep 2026 ➔ Jan 2027 | Trial primary completion date: Sep 2026 ➔ Jan 2027

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

Cost-Savings Analysis of Fitusiran Prophylaxis: Reducing Breakthrough Bleeding Treatment Expenditure in the Kingdom of Saudi Arabia (ISPOR-EU 2025) - P3 | "For people with haemophilia (PwH) A without inhibitors, episodic treatments comprised octocog alfa, efmoroctocog alfa and rurioctocog alfa pegol for PwH A and nonacog alfa, albutrepenonacog alfa and eftrenonacog alfa for PwH B. Treatments included for PwH with inhibitors were factor VIII inhibitor bypassing activity (FEIBA) and eptacog alfa. In the KSA, fitusiran AT-DR prophylaxis may considerably reduce breakthrough bleed management costs in PwH versus CFC/BPA prophylaxis. Cost savings are predicted to be more substantial in PwH with inhibitors than in those without inhibitors."

HEOR • Hematological Disorders • Hemophilia • Rare Diseases

Transplacental Transfer of Emicizumab: Experience with Emicizumab in a Pregnant Female with Severe Hemophilia Α and an Inhibitor (ASH 2023) - "She was not treated with immune tolerance induction and had remained on factor eight inhibitor bypassing activity (FEIBA) as prophylaxis until transferring to our center. She was transitioned to monthly emi prophylaxis and recombinant FVIIa (rFVIIa, NovoSeven) for breakthrough bleeding at age 26...Her labor was induced with oxytocin while on rFVIIa and tranexamic acid (TXA) support... In this highly unusual case, we demonstrate that emi crossed the placenta and is excreted in breast milk. We also demonstrate that the maternal FVIII inhibitor did not cross the placenta into the newborn. Drawing conclusions on the safety of emi despite placental and breast milk transmission and transmissibility of inhibitor based on a single case would be premature."

Hematological Disorders • Hemophilia • Hemophilia A • Postpartum Hemorrhage • Rare Diseases

Cost-Savings Assessment of Fitusiran Prophylaxis in Minimizing Breakthrough Bleeding Treatment Expenses in the United Arab Emirates (ISPOR-EU 2025) - P3 | "The episodic treatments included were efmoroctocog alfa, octocog alfa and rurioctocog alfa pegol for people with haemophilia (PwH) A without inhibitors and albutrepenonacog alfa, nonacog alfa and eftrenonacog alfa for PwH B without inhibitors...A scenario analysis examined the impact of vial sharing. Among PwH without inhibitors, fitusiran AT-DR enabled per-bleed savings ranging from UAE Dirham (AED) 4,625 (efmoroctocog alfa) to AED 11,521 (rurioctocog alfa pegol) in PwH A and from AED 8,935 (nonacog alfa) to AED 30,053 (albutrepenonacog alfa) in PwH B. In PwH with inhibitors, fitusiran AT-DR usage generated per-bleed savings of AED 71,846 (FEIBA) to AED 90,761 (eptacog alfa). In the UAE, fitusiran AT-DR prophylaxis may considerably reduce costs associated with episodic treatments for breakthrough bleeds in PwH compared with CFC/BPA prophylaxis. PwH with inhibitors might have larger cost savings than those without inhibitors."

HEOR • Hematological Disorders • Hemophilia • Rare Diseases

A Single Center Experience of 13 Episodes of Acquired Hemophilia A (2019 - 2023) (ASH 2023) - "The use of aPCC (FEIBA) instead of rFVIIa (NovoSeven) as the first-line BPA led to total estimated cost avoidance of $13. We describe 13 episodes of AHA successfully treated at a single academic medical center between 2019 and 2023. aPCC was the first-line BPA administered in all patients, with significant cost savings relative to rFVIIa. Immunosuppression, including prednisone and either cyclophosphamide or rituximab, was used to successfully eliminate autoantibodies in all patients."

Clinical • Hemophilia • Hemophilia A • Hepatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Rare Diseases • Respiratory Diseases

Evaluating Effective Therapeutic Options for Inhibitor Eradication in Patients with Acquired Hemophilia a: A 10-Year Single Center Experience (ASH 2023) - "At our institute, all patients received 1mg/kg of steroids initially, then either six cycles of 400mg/kg IV Cyclophosphamide every 28 days on day 1 along with 100mg of oral Prednisone days 1-5 or four cycles of IV Rituximab at a weekly dose of 375mg/m2 was used as 1stline IST for patients with inhibitor titer >10%...In few patients oral Cyclophosphamide or Mycophenolate mofetil was used as maintenance therapy after 1st or 2nd line therapy. Bleeding control was achieved with use of rpFVIII or rFVII, FEIBA or emicizumab depending on product availability...Our analysis also revealed that initial inhibitor titer may serve as a useful predictor of disease course, potentially guiding therapeutic decision-making and eliminating need for cytotoxic medication or maintenance therapy. Future large prospective studies are needed to confirm these findings and further investigate other factors influencing therapeutic outcomes in patients with AHA."

Clinical • Hematological Disorders • Hemophilia • Hemophilia A • Rare 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

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

FEIBA-Induced Delirium in a Patient With Acquired Hemophilia. (PubMed, Am J Ther) - No abstract available

Journal • CNS Disorders • Hematological Disorders • Hemophilia • Rare Diseases

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