apixaban / Generic mfg. - LARVOL DELTA

Safety and optimal use of direct oral anticoagulant therapy. (PubMed, Expert Opin Drug Saf) - "This review summarizes the pharmacokinetic and pharmacodynamic profiles of commercially available DOACs (apixaban, rivaroxaban, dabigatran, and edoxaban), as well as their efficacy and safety in the settings of atrial fibrillation, venous thromboembolism, prevention of cancer-associated thrombotic events, and atherosclerotic disease. The introduction into clinical practice of DOACs has significantly changed the landscape of OAC, given their favorable safety and efficacy profiles. However, there are still several unmet needs for patients requiring treatment with OAC, underscoring the need for further research in the field to optimize the safety and efficacy of these agents across different clinical settings."

Journal • Review • Atherosclerosis • Atrial Fibrillation • Cardiovascular • Coronary Artery Disease • Oncology • Venous Thromboembolism

Multiple intra-cavitary thrombi in a late-onset dilated cardiomyopathy with severely reduced ejection fraction: A case report and review of the literature. (PubMed, JRSM Cardiovasc Dis) - "The patient was treated with intravenous diuretics, non-invasive ventilation, unfractionated heparin followed by apixaban, and guideline-directed medical therapy for heart failure, including a beta-blocker, angiotensin receptor-neprilysin inhibitor, MRA, and SGLT2 inhibitor...This case highlights the importance of early recognition and prompt anticoagulation in dilated cardiomyopathy complicated by left ventricular thrombi. A structured diagnostic and therapeutic strategy-integrating multimodality imaging, exclusion of secondary causes, and genetic assessment-can lead to complete thrombus resolution and favorable remodeling."

Journal • Cardiomyopathy • Cardiovascular • CNS Disorders • Congestive Heart Failure • Coronary Artery Disease • Depression • Dyslipidemia • Fibrosis • Heart Failure • Hematological Disorders • Immunology • Metabolic Disorders • Psychiatry • Pulmonary Disease • Thrombosis

Peripheral Nerve Stimulation for Cervical Radiculopathy in the Setting of Overlapping Shoulder Osteoarthritis: A Case Report (ASRA-FALL 2025) - "The patient had multiple comorbidities precluding surgical intervention, including atrial fibrillation on apixaban, type 2 diabetes mellitus, and severe obesity. T he patient experienced severe right upper extremity pain due to C5–C7 cervical radiculopathy and advanced right glenohumeral arthritis with pain scores consistently ranging from 6 to 10/10 despite conservative treatment. Initial interventions included physical therapy, titrated pregabalin/gabapentin, multiple right shoulder corticosteroid injections, suprascapular nerve blocks, and a C7–T1 cervical epidural steroid injection. These interventions provided only transient or minimal relief as the patient's pain appeared multifactorial, as he would have partial responsiveness to shoulder and neck pain with injections but ongoing debilitating radicular symptoms and remained unable to lift his arm overhead, limiting daily function."

Case report • Clinical • Atrial Fibrillation • Cardiovascular • Diabetes • Genetic Disorders • Immunology • Metabolic Disorders • Musculoskeletal Pain • Neuralgia • Obesity • Osteoarthritis • Pain • Rheumatology • Type 2 Diabetes Mellitus

Real-World Impact of Amiodarone on Apixaban Population Pharmacokinetics in Hospitalized Patients. (PubMed, Clin Transl Sci) - "Overall differences in apixaban exposures do not appear to be clinically significant across both dosing regimens, but amiodarone coadministration was found to decrease apixaban clearance by 33% (ranging from 12% to 48%). The results support the current practice of no empiric dose adjustment for apixaban when concurrently administered with amiodarone."

Journal • PK/PD data • Real-world evidence • Atrial Fibrillation • Cardiovascular

Two Mechanistically Distinct Factor XI Antibodies, REGN9933A2 and REGN7508Cat, for the Prevention of Venous Thromboembolism After Knee Arthroplasty: the ROXI-VTE-I and ROXI-VTE-II Trials (AHA 2025) - P2 | "We compared the efficacy and safety of REGN9933A2 with enoxaparin and apixaban (as an exploratory comparator), and REGN7508Cat with enoxaparin for venous thromboembolism (VTE) prevention. ROXI-VTE-I (NCT05618808) and ROXI-VTE-II (NCT06454630) are randomized, open-label, phase 2 studies conducted in patients undergoing knee arthroplasty. REGN7508Cat was superior to enoxaparin for VTE prevention; REGN9933A2 was not superior to enoxaparin. The results with REGN7508Cat confirm the role of FXI in postoperative VTE; the results with REGN9933A2 suggest that FXIIa-driven FXI activation contributes to this process."

Cardiovascular • Hematological Disorders • Orthopedics • Venous Thromboembolism

Modernising Acute PE and VTE Management: Meta-Analysis of Newer Anticoagulants Versus Traditional Therapy on Recurrence and Mortality. (PubMed, Heart Lung Circ) - "Factor Xa inhibitors are effective and safe alternatives to traditional anticoagulants for most patients with acute VTE. They significantly reduce VTE recurrence, particularly in patients with cancer and bleeding-related mortality. Major bleeding was significantly less in the non-cancer subgroup. These findings support their use as first-line therapy in appropriately selected patients, with consideration of individual bleeding risk, cancer type, renal function, and treatment setting."

Journal • Retrospective data • Review • Cardiovascular • Hematological Disorders • Oncology • Renal Disease • Respiratory Diseases • Solid Tumor • Venous Thromboembolism

A Curious Case Of Severe Asthma (ACAAI 2025) - "Despite compliance with Fluticasone propionate/Salmeterol 500/50 mcg, Tiotoprium 2.5 mcg, she was using her Levalbuterol MDI daily...Six weeks later, she reported that her exercise tolerance and dyspnea were significantly improved after a week of treatment with Apixaban. She had not needed her Levalbuterol inhaler since her last appointment. Discussion It is important to consider alternative diagnoses and a patient’s medical history when asthma is not well-controlled, especially when one has unique symptoms and is not responding to traditional asthma medications."

Clinical • Allergic Rhinitis • Asthma • Cardiovascular • Immunology • Inflammation • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases

DOAC-Induced DRESS In A Patient With CLL Factor V Leiden And Extensive Anticoagulant Intolerance (ACAAI 2025) - "While commonly associated with anticonvulsants, allopurinol, and antibiotics, DRESS due to direct oral anticoagulants (DOACs) is rarely reported...He has a complex anticoagulation history: He developed a prior rash to apixaban and was switched to dabigatran. He sustained clots on dabigatran, so he was transitioned to rivaroxaban...Although cross-reactivity among DOACs has not been well-established, this case raises concern for potential class effect among factor Xa inhibitors. The patient’s immunocompromised state from CLL may have contributed to his susceptibility to DRESS."

Clinical • Chronic Lymphocytic Leukemia • Dermatology • Dermatopathology • Eosinophilia • Immunology • Venous Thromboembolism

Risk of venous and arterial thromboembolic events following CAR-T therapy in relapsed or refractory non-Hodgkin lymphoma: A propensity-matched multicenter analysis. (ASH 2025) - "The CAR-T cohort included patients who received anyFDA-approved CAR-T product (axi-cel, tisa-cel, liso-cel)...Propensity score matching (1:1, nearest neighbor, caliper 0.1) was performed to balance baselinecharacteristics, including age, sex, race, hypertension, diabetes, hyperlipidemia, chronic ischemic heartdisease, chronic kidney disease (all stages), atrial fibrillation, prior ischemic heart disease, priorthromboembolic events, and use of aspirin, warfarin, apixaban, clopidogrel, ticagrelor, or rivaroxabanbefore CAR-T cell therapy... In this large propensity score–matched analysis of patients with relapsed or refractory NHL, CAR-Ttherapy was associated with a substantially higher 90-day risk of venous thromboembolism and acutelimb ischemia in the early post–CAR-T period. These findings highlight the need for close clinicalmonitoring and the potential role of preventive strategies, such as the use of prophylacticanticoagulation in patients with a low risk of bleeding."

Clinical • Chronic Kidney Disease • CNS Disorders • Diabetes • Diffuse Large B Cell Lymphoma • Dyslipidemia • Follicular Lymphoma • Heart Failure • Hematological Malignancies • Hypertension • Lymphoma • Non-Hodgkin’s Lymphoma

Impact of increased patient out-of-pocket costs on oral anticoagulant discontinuation among Medicare beneficiaries with atrial fibrillation treated with apixaban. (PubMed, Curr Med Res Opin) - "After multivariable adjustment, each $50 increase in monthly OOP costs was associated with a 1.27 times higher likelihood of treatment discontinuation (p < 0.05). Following the formulary tier increase of apixaban from 2016 to 2017, increases in OOP costs was associated with a significantly higher probability of treatment discontinuation among Medicare beneficiaries with AF."

Journal • Medicare • Reimbursement • US reimbursement • Atrial Fibrillation • Cardiovascular

Pfizer Reports Solid Third-Quarter 2025 Results; Raises and Narrows 2025 EPS Guidance (Pfizer Press Release) - "Third-quarter 2025 operational revenue reflected higher revenues primarily for: Eliquis globally, up 22% operationally, driven primarily by higher demand globally and favorable net price in the U.S...Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 7% operationally, driven largely by strong demand with continuing uptake in patient diagnosis primarily in the U.S. and certain international developed markets....Nurtec ODT/Vydura globally, up 22% operationally, driven primarily by strong demand in the U.S. and recent launches in certain international markets, partially offset by lower net price in the U.S. mainly due to unfavorable changes in channel mix."

Sales • Amyloidosis • Atrial Fibrillation • Cardiomyopathy • Migraine • Pulmonary Embolism • Venous Thromboembolism

Oral anticoagulants and gastrointestinal bleeding: pharmacovigilance insights from the FDA adverse event reporting system database. (PubMed, Int J Surg) - "DOACs showed a significantly lower risk of GIB than VKAs, though dabigatran exhibited a higher risk of lower GIB compared to other OACs. Different OACs exhibited distinct risk profiles across GIB locations, providing critical insights for optimizing anticoagulation management strategies."

Adverse events • Journal • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders

Apixaban kinetics could be influenced by sex, cytochrome P450 enzymes and SLC6A2 transporter. (PubMed, Biomed Pharmacother) - "Carriers of the rs3093200 variant in CYP4F2 showed a decrease in Cmax/DW (p = 0.049, pmv=0.020). Further studies are needed to understand the involvement of these genes in apixaban kinetics."

Journal • ABCC2 • CYP3A4 • CYP3A5 • SLC22A1

CORRAL-AF: Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Brian O'Neill MD | N=2931 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Thrombosis

A National Response to Warfarin Shortages: Evaluating Regulatory Substitution and Notified Shortages and Their Effects on Antithrombotic Dispensings, Pathology Monitoring and Adverse Event Trends in Australia. (PubMed, Drug Saf) - "Warfarin supply was maintained during the 2023 shortage through strength-based substitution under the SSSI, with limited impact on DOAC dispensing."

Adverse events • Journal • Thrombosis

Standardized Thromboembolism Prophylaxis in Orthopedic Patients to Prevent Venous ThromboEmbolism Study: A Novel Prospectively Validated Electronic Risk Stratification Tool for Elective Hip and Knee Joint Replacement Patients. (PubMed, JB JS Open Access) - "The model classified patients as at high or standard risk of VTE and recommended anticoagulation (mostly apixaban 2.5 mg twice daily for 28 days) or aspirin (81 mg twice daily) prophylaxis, respectively. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence."

Journal • Cardiovascular • Hematological Disorders • Orthopedics • Respiratory Diseases • Venous Thromboembolism

Is there an optimal time to transition to low dose direct oral anticoagulants? (ASH 2025) - "Background : Prophylactic-dose or low-dose apixaban and rivaroxaban have been studied in randomizedcontrolled trials for the extended prevention of venous thromboembolism (VTE) after 6 months oftreatment with therapeutic anticoagulation. This real-world patient population demonstrates that anticoagulant prescribers transition tolow-dose DOACs ahead of the historically studied 6-month time point. The results of this study do notindicate a significant difference in clinical outcomes of VTE recurrence or bleeding complications basedon time of transition to low-dose DOACs either before or after 6 months."

Venous Thromboembolism

Efficacy and safety of low-dose vs. standard-dose direct oral anticoagulants for secondary prevention of venous thromboembolism: A systematic review and meta-analysis (ASH 2025) - "This meta-analysisevaluates the efficacy and safety of reduced-dose versus standard-dose DOACs for extended VTEtreatment in the general population, high-risk subgroups, and patients with clinical equipoise regardingthe continuation of anticoagulation.We conducted a meta-analysis of randomized controlled trials (RCTs) evaluating reduced dose apixaban(2.5 mg twice daily) or rivaroxaban (10 mg once daily), compared to their respective standard dose (5 mgtwice daily for apixaban, 20 mg once daily for rivaroxaban) for the extended treatment of venousthromboembolism (VTE). Reduced-dose DOACs appear to preserve efficacy while significantly lowering bleeding risk compared tostandard-dose regimens for extended VTE treatment. These benefits were consistent across studiedclinical subgroups, although a possible sex-based interaction was observed for VTE recurrence. Thesefindings support the use of reduced-dose DOACs as a safer alternative for extended anticoagulation andhighlight..."

Retrospective data • Review • Cardiovascular • Hematological Disorders • Respiratory Diseases • Venous Thromboembolism

Comparative effectiveness and safety of apixaban vs. rivaroxaban in patients with cirrhosis and portal vein thrombosis: An analysis of real-world data (ASH 2025) - "Anticoagulation is recommended to treat PVT despite low-certaintyevidence, largely derived from studies of heparin and warfarin. In this real-world cohort of patients with cirrhosis and PVT, apixaban and rivaroxaban were associatedwith similar effectiveness. Use of apixaban was associated with a lower incidence of bleeding thanrivaroxaban, although the CI included the null value of one. These findings are consistent with itsfavorable pharmacokinetic profile in hepatic impairment and with observations in other populations."

Clinical • HEOR • Real-world • Real-world evidence • Atrial Fibrillation • Biliary Cancer • Cardiovascular • Cerebral Hemorrhage • Chronic Kidney Disease • CNS Disorders • Fibrosis • Gastrointestinal Disorder • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Nephrology • Renal Disease • Thrombosis • Venous Thromboembolism

primary thromboprophylaxis using direct oral anti-coagulants (DOAC) in malignant pediatric tumors with vascular compression (ASH 2025) - "Sarangi previously demonstrated a reduction inthrombotic events for patients with mediastinal masses and tumor-related vascular compression (TRVC)who received prophylactic enoxaparin (Sarangi et...Fourteen patients (≥12 years and >40 kg) receivedapixaban (2.5 mg twice a day) and 5 patients received rivaroxaban (weight-based dosing)...On apixaban, 1 patient had rapid self-resolution of epistaxis, and another had hematuria withconcurrent ifosfamide administration...Though limited by its mostly retrospective design, small sample size, and single-institution population,our study highlights an at-risk subgroup of pediatric oncology patients with TRVC that may benefit fromuniversal primary thromboprophylaxis with a DOAC. Larger studies are needed to evaluate this further."

Clinical • Desmoid Tumors • Fibrosis • Hematological Malignancies • Lymphoma • Neuroblastoma • Obesity • Oncology • Pediatrics • Sarcoma • Solid Tumor • Venous Thromboembolism

Abbreviated anticoagulation regimen with direct oral anticoagulants is safe and efficacious in the management of infection-associated cerebral sinovenous thrombosis in children (ASH 2025) - "Forty-five (96%) patients were started on unfractionated heparin (UFH) orlow molecular weight heparin, and 15 (32%) were transitioned to rivaroxaban or apixaban. One patient died of an underlying malignancy.ConclusionOur data suggests that an abbreviated course of anticoagulation using DOACs is safe and efficacious inthe management of infection-associated CSVT in children. Additionally, thrombophilia work-up is lowyield and likely not indicated in this cohort."

Clinical • Cardiovascular • Infectious Disease • Otorhinolaryngology • Pediatrics • Respiratory Diseases • Sinusitis • Thrombosis • Venous Thromboembolism

Extended duration anticoagulation in cancer associated thrombosis (ASH 2025) - "Prophylactic dose of anticoagulation wasdefined as apixaban 2.5mg BD, rivaroxaban 10mg OD or enoxaparin 40mg OD (20mg OD for weight<50kg). Low dose anticoagulation is used in clinical practice for secondary thromboprophylaxis in patients withCAT without a signal for increased VTE recurrence and with low bleeding complications. Further data arerequired on the longer-term continuation of this thromboprophylactic strategy in an era when patientsare living longer with advanced cancer."

Oncology • Thrombosis

Pharmacometric analyses supporting apixaban doses in neonates with venous thromboembolism (ASH 2025) - P2, P3, P4 | "US PrescribingInformation. Bristol Myers Squibb, 2025) pediatric dosing strategy in neonates.Study supportStudy and professional writing support were funded by Pfizer/Bristol Myers Squibb."

Cardiovascular • Pediatrics • Venous Thromboembolism

Reduced versus standard dose apixaban for secondary prevention of cancer-associated venous thromboembolism: A systematic review and meta-analysis (ASH 2025) - "These findings suggest that reduced-dose apixaban mayoffer a safer alternative for long-term anticoagulation in selected oncology patients. Further prospective,stratified studies are needed to validate these results and guide individualized anticoagulation strategiesin cancer-associated thrombosis."

Retrospective data • Review • Oncology • Respiratory Diseases • Venous Thromboembolism

Risk of bleeding in chronic lymphocytic leukemia patients in remission treated with covalent Bruton tyrosine kinase inhibitors and contemporary anticoagulant or antiplatelet drugs: Real-world data analysis (ASH 2025) - "The study population was divided into two main cohorts: 1) Cohort 1: CLLpatients in remission treated with covalent BTKi (ibrutinib/acalabrutinib/zanubrutinib) concurrentlytreated with AC (rivaroxaban/apixaban/edoxaban/dabigatran) or AP agents (acetylsalicylicacid/clopidogrel/prasugrel/ticagrelor/ticlopidin), and 2) Cohort 2: CLL patients in remission treated withcovalent BTKi (ibrutinib/acalabrutinib/zanubrutinib) not concurrently treated with AC or AP agents.Cohort 1 was further subdivided into two groups: those treated only with AC and those treated only withAP. CLL patients in remission treated with covalent BTKis experience a significant risk ofbleeding events. This risk is substantially elevated when covalent BTKis therapy is combined with eitheranticoagulant or antiplatelet agents. Notably, our findings indicate no discernible difference in bleedingrisk between AC or AP agents when used concurrently with covalent BTKis."

Clinical • Real-world • Real-world evidence • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia