AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca - LARVOL DELTA

SPLENIC LACERATION AND HEMORRHAGE FOLLOWING ROUTINE COLONOSCOPY IN A PATIENT ON ANTICOAGULATION THERPAY: A COMPLEX CASE MANAGEMENT (SSAT 2025) - "Apixaban was withheld, and Andexanet alfa was used for reversal. Small volume abdominal and pelvic hemoperitoneum.Fig 2: Splenic capsular injury/capsular rupture with mildly increased, large perisplenic hematoma and hemoperitoneum with now no evidence of current contrast extravasation. The lesion now can be classified as AAST grade III injury."

Clinical • Atrial Fibrillation • Breast Cancer • Cardiovascular • Hematological Disorders • Hypertension • Hypotension • Musculoskeletal Pain • Oncology • Pain • Solid Tumor

Anticoagulant prescribing trends, bleeding events, and reversal agent use in pediatric patients: A retrospective, real-world study. (PubMed, PLoS One) - "This retrospective real-world study aimed to describe anticoagulant prescribing trends, particularly for factor Xa (FXa) inhibitors, bleeding events, and reversal agent use in pediatric patients to assess potential populations for clinical trials of the FXa inhibitor reversal agent andexanet alfa. Real-world health care data from the TriNetX Global Network and Optum's deidentified Clinformatics® Data Mart Database (CDM) were analyzed to identify patients aged <18 years old who were prescribed a direct oral FXa inhibitor, warfarin, or low-molecular-weight heparins from 2007 through 2024 (TriNetX, N = 59,780) or 2023 (CDM, N = 6470)...Prescriptions of the FXa inhibitor rivaroxaban increased from 0.4% (2009) to 18.0% (2023) in TriNetX and from 0.8% (2011) to 34.0% (2023) in CDM, with similar trends for apixaban...Direct oral FXa inhibitor use in children is growing, as is the potential for associated bleeds; however, reversal agent use is rare in this..."

Journal • Real-world evidence • Retrospective data • Pediatrics

Management of Direct Oral Anticoagulants in Acute Type A Aortic Dissection. (PubMed, Aorta (Stamford)) - " This case series demonstrates that preoperative management of DOACs in patients with ATAAD may employ factor repletion with success. Literature review demonstrated a safety signal for heparin insensitivity or pump thrombosis when andexanet-alfa was administered before or while on cardiopulmonary bypass or extracorporeal membrane oxygenation. Our institutional clinical practice guidelines recommend against administration of andexanet-alfa within 4 to 6 hours before heparinization for surgery in ATAAD but recommend considering andexanet-alfa administration when there is life-threatening bleeding after heparin reversal that is thought to be due to Xa-inhibition with laboratory evidence of elevated anti-Xa activity."

Journal • Cardiovascular • Hematological Disorders • Thrombosis

SPLENIC LACERATION AND HEMORRHAGE FOLLOWING ROUTINE COLONOSCOPY IN A PATIENT ON ANTICOAGULATION THERPAY: A COMPLEX CASE MANAGEMENT (DDW 2025) - "Apixaban was withheld, and Andexanet alfa was used for reversal. This case underscores the importance of early recognition and multidisciplinary management of splenic injuries in patients on anticoagulation therapy. Splenic artery embolization can be life saving and should be considered in severe injuries to preserve splenic function."

Clinical • Atrial Fibrillation • Breast Cancer • Cardiovascular • Hematological Disorders • Hypertension • Hypotension • Musculoskeletal Pain • Oncology • Pain • Solid Tumor

Treatment results of intracranial hemorrhage with andexanet alfa at our hospital (JSNE 2025) - No abstract available

Clinical • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

Relationship between the onset of cerebral infarction after andexanet alfa administration and PT-INR (JSNE 2025) - No abstract available

CNS Disorders

Andexanet alfa in patients with spontaneous intracerebral hemorrhage related to apixaban or rivaroxaban. (PubMed, Neurol Sci) - No abstract available

Journal • Cerebral Hemorrhage • Hematological Disorders

When Too Much Anticoagulation Becomes Hazardous: A Case Report of Massive Apixaban Overdose (ATS 2025) - "Unlike warfarin does not require any biological monitoring thanks ease of use...Diuresis with furosemide was attempted but oxygen requirements did not improve. At this time there was a high suspicion for TRALI but given patient and family wishes, he was transitioned to comfort and expired.Management of toxicity regards to DOAC such as rivaroxaban and apixaban were largely based on the ANNEXA trials...Studies comparing prothrombin complex concentrate and Andexanet showed similar clinical outcomes in terms of mortality and anticoagulation reversal. There have also been studies both pharmacologic and outcomes based on the utility of early administration of activated charcoal for ingestions of DOACs3."

Case report • Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypotension • Peripheral Arterial Disease • ACSL3

Use of Andexanet Alpha Versus Standard of Care Among Patients Hospitalized With Upper and Lower Gastrointestinal Bleeding: A Retrospective, Multicenter, Comparative Effectiveness Study (ATS 2025) - "Patients who present with a gastrointestinal bleed (GIB) while on rivaroxaban or apixaban may receive reversal agents such as protein complex concentrate (PCC; KCentra) or Andexanet alfa (AA). In this retrospective, multicenter comparative effectiveness study, there were no differences in time to mortality in patients who received AA compared to those who received PCC. However, effect estimates for mortality, thromboembolic events, and need for transfusion all favored PCC over AA. Figure 1."

HEOR • Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Immunology

Emergent cardiac surgery, andexanet alfa-induced heparin resistance, and prothrombotic effects: coagulation chaos? (PubMed, J Thromb Haemost) - No abstract available

Journal • Cardiovascular

Association of Biomarkers With Intracerebral Hematoma Expansion and Arterial Thromboembolic Events in Patients With Acute Intracranial Hemorrhage: The ANNEXA-I Biomarker Substudy. (PubMed, Stroke) - P4 | "In patients with apixaban- or rivaroxaban-associated intracranial hemorrhage, andexanet compared with usual care produces greater reduction in anti-FXa and greater increase in ETP at 1 hour. Reduction in anti-FXa from baseline to 1 hour is independently associated with reduced hematoma expansion, and increase in ETP from baseline to 1 hour is independently associated with both reduced hematoma expansion and increase of thromboembolic events. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03661528."

Biomarker • Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke • Myocardial Infarction

TFPIα activity suppression by Andexanet alfa is partially restored by protein S and factor V-short (BSH 2025) - No abstract available

Cardiovascular • Hematological Disorders • Thrombosis • PROS1

Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation) (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: AstraZeneca | Trial completion date: May 2025 ➔ Nov 2025 | Trial primary completion date: May 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date

CuratED: The emergency medicine pharmacotherapy literature of 2024. (PubMed, Am J Emerg Med) - "Covered topics include guideline updates on seizure prophylaxis in traumatic brain injury, corticosteroid use in sepsis and acute respiratory distress and antibiotic prophylaxis in trauma. Additional topics include updates on thrombolytic therapy for acute ischemic stroke, including tenecteplase versus alteplase, anticoagulation reversal strategies with andexanet alpha and prothrombin complex concentrate, and the use of tranexamic acid in traumatic brain injury, ketamine versus etomidate for intubation in critically ill adults, expert consensus on heart failure hospitalization management, geriatric emergency medication safety recommendations, and emerging data on dual antiplatelet therapy for stroke management."

Journal • Review • Acute Respiratory Distress Syndrome • Cardiovascular • CNS Disorders • Congestive Heart Failure • Epilepsy • Heart Failure • Infectious Disease • Ischemic stroke • Septic Shock • Vascular Neurology

Andexanet alfa for reversal of intracerebral haemorrhage resulting in ST-segment myocardial infarction: a case report. (PubMed, Eur Heart J Case Rep) - "A 76-year-old male presented with atrial fibrillation with rapid ventricular response and was started on Eliquis after a successful direct current cardioversion. Current European Society of Cardiology Guidelines do not have recommendations for the use of andexanet alfa for the reversal of anticoagulation due to its uncertain risk profile. This case emphasizes the increased risk of thrombotic complications associated with andexanet alfa and highlights the importance of the continued need to research its use, which may help elucidate or revise current guidelines."

Journal • Atrial Fibrillation • Cardiovascular • Myocardial Infarction • Renal Disease • Respiratory Diseases • Septic Shock

Safety of direct oral anticoagulants reversal agents in older patients: an analysis of individual case safety reports of adverse drug reaction from VigiBase®. (PubMed, Aging Clin Exp Res) - "Clinicians should pay particular attention when managing individuals needing these drugs, especially if vulnerable and requiring polytherapy."

Adverse drug reaction • Journal • Retrospective data • Cardiovascular

Rapid Determination of Xa Inhibitor Activity in Blood Using a Microfluidic Device that Measures Platelet Deposition and Fibrin Generation Under Flow. (PubMed, TH Open) - "The assay simultaneously measured whole blood clotting dynamics on collagen/tissue factor (TF; wall shear rate, 200 -1 ) under four ex vivo conditions: no-treatment control, high dose Factor Xa inhibition, low dose or high dose FXa reversal agent (andexanet alfa). For a threshold of 100 nM DOAC, the area under the curve (AUC) was found to be 0.881 for apixaban and 0.933 for rivaroxaban. Microfluidic testing of whole blood can provide a rapid estimate of DOAC levels over the on-therapy range."

Journal • Atrial Fibrillation • Cardiovascular • Venous Thromboembolism

Reversal of Factor Xa Inhibitor-Related Intracranial Hemorrhage: A Multicenter, Retrospective, Observational Study Comparing the Efficacy and Safety of Andexanet and Prothrombin Complex Concentrates. (PubMed, Crit Care Med) - "Despite statistically higher odds of achieving hemostatic efficacy with andexanet, we also observed higher odds of a TE with no difference in discharge outcomes observed between groups. When those with more severe neurologic injuries were excluded, efficacy and safety outcomes were similar between treatments."

Journal • Observational data • Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

Andexanet Alfa in Urgent Cardiac Surgery: A Case Report of Edoxaban Reversal for Acute Hemopericardium. (PubMed, Am J Case Rep) - "BACKGROUND Antidotes to non-vitamin K oral anticoagulants (NOAK) like idarucizumab and andexanet alfa have been approved for reversing the effects of dabigatran and apixaban/rivaroxaban, respectively. Successful management was achieved through a multidisciplinary approach. Further research is needed to evaluate the safety and efficacy of andexanet alfa in patients on edoxaban therapy."

Journal • Cardiovascular • Hematological Disorders

"Reversal of direct oral anticoagulants: Guidance from the SSC of the ISTH": Reply. (PubMed, J Thromb Haemost) - No abstract available

Journal

Efficacy and safety of andexanet alfa for factor Xa inhibitor-associated intracranial haemorrhage. (PubMed, J Neurol Neurosurg Psychiatry) - "The present meta-analysis suggests AA is associated with improved haemostatic efficacy compared with usual care, with no significant differences observed in functional and safety outcomes. These findings indicate that AA may have a role in the management of factor Xa inhibitor-associated ICH, although further high-quality studies are needed to better define its net clinical benefit."

Clinical • Journal • Cerebral Hemorrhage

Real-world andexanet alfa utilization and the association between delay in administration due to hospital transfer and all-cause inpatient mortality. (PubMed, Res Pract Thromb Haemost) - "Cases with hospital transfer had an 82% increased odds of all-cause inpatient mortality (95% CI, 17%-183%) but did not reach statistical significance when the population was limited to intracranial hemorrhage (odds ratio, 1.51; 95% CI, 0.88-2.60). Delay in administering andexanet alfa due to hospital transfer may be associated with increased all-cause mortality."

Journal • Real-world evidence • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

Andexanet Alfa Versus 4F-PCC for Direct Anticoagulation Reversal in Intracranial Hemorrhage: A Quality Improvement (QI) Analysis (AAN 2025) - "57 patients were on apixaban, 14 on rivaroxaban, and 1 on fondaparinux. The findings of our analysis indicate that 4F-PCC and andexanet alfa are similarly effective in DOAC reversal for patients with ICH at our institution."

Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

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

Risk Factors for Thromboischemic Complications After Andexanet Alfa Reversal of Factor Xa Inhibitors (SCCM 2025) - "Most patients were prescribed apixaban (97 (66.4%) for atrial fibrillation (95 [65.1%] and received low-dose AA (127 [86.9%]) for an intracranial bleed (106 [72.6%]). Patients with a BMI > 40 kg/m2 are at a higher risk for TE post-reversal with AA. Further research is warranted to identify ideal populations for reversal with AA while minimizing risk of TE."

Clinical • Atrial Fibrillation • Cardiovascular • CNS Disorders • Ischemic stroke • Myocardial Infarction • Oncology • Respiratory Diseases • Venous Thromboembolism