Feraheme (ferumoxytol injection) / Azurity Pharma - LARVOL DELTA

Parental replacement therapy with iron dextran or ferumoxytol in patients with iron defiency (ASH 2025) - "In patients with iron deficiency, the change of the hematological parameters after replacement therapy was not statistically different between iron dextran and ferumoxytol. Our data suggests that these two formulations have similar efficacy and safety after the IV administration of a single dose of 1,020 mg."

Clinical • Hematological Disorders

High versus low-cost intravenous iron in Medicare: Utilization patterns of iron infusions in traditional fee-for-service Medicare and Medicare advantage for iron deficiency anemia (ASH 2025) - "The mostcommon infusions were iron sucrose (43%), ferric carboxymaltose (23%), ferumoxytol (18%), iron dextran(8%), ferric gluconate (6%) and derisomaltose (1%). This could be due to incentivedifferences offered by various plan structures in MA relative to TM. Future research should assess thedownstream implications of these patterns overtime, on outcomes and on cost-effectiveness."

Medicare • Reimbursement • US reimbursement • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Iron infusions in pregnant women are associated with comparable efficacy and safety compared to non-pregnant women (ASH 2025) - "Two weeks after the final infusion,follow-up iron and blood counts were measured, and symptoms were re-assessed in a follow-up visit.Safety and tolerability of iron infusions were determined by reviewing frequency of reactions thatoccurred during infusions (observed) including complement activation-related pseudo allergy (CARPA)and immune-mediated hypersensitivity reactions, as well as transient discomfort within the first few daysafter iron infusions (assessed by self-reports or reported during follow-up visits). 2,225 pregnant women and 632 non-pregnant women received 6,486 iron infusions betweenJune 2021 and June 2023, including Ferric Derisomaltose (FDI) 1000 mg (n=819), Ferumoxytol (FM) 510 mgper dose (n=601), or Iron Sucrose (IS) 200-400mg per dose (n=1,437)... Iron infusions are equally effective and safe in pregnant women as they are in non-pregnantwomen. This study noted slightly more post-infusion discomfort symptoms in pregnant women, whichcan sometimes..."

Clinical • Back Pain • Immunology • Lumbar Back Pain • Musculoskeletal Pain

A comparison of intravenous iron formulations for treating iron deficiency anemia after bariatric surgery (ASH 2025) - "Newer IV iron formulations that can correct deficits in one or two infusions (ferric carboxymaltose,ferric derisomaltose, and ferumoxytol) are favored over multiple-infusion agents like iron sucrose.Although IV iron may be more effective, potential side effects—such as post-infusion hypophosphatemia—must be carefully monitored post-bariatric surgery, as secondary hyperparathyroidism from vitamin Ddeficiency and calcium malabsorption may exacerbate this complication.We performed a retrospective, single-center study of adult patients treated with IV iron for iron-deficiency anemia (IDA) after bariatric surgery from January 2021 to March 2025...Although our small retrospective cohort limits definitive conclusions, trends suggest that newer IV ironformulations may provide more effective correction of IDA post-bariatric surgery than iron sucrose—consistent with practice guidelines to use one- to two-dose regimens. Additionally, hypophosphatemiadeveloped in two vitamin D..."

Bariatric surgery • Surgery • Anemia • Chronic Kidney Disease • Gastrointestinal Disorder • Immunology • Nephrology • Renal Disease • Secondary Hyperparathyroidism

Safety and efficacy analysis of IV iron formulations in children: Results from a large pediatric cohort (ASH 2025) - "Statistical analysis was performed usingWilcoxon signed-rank test for paired analysis of pre/post treatment labs, Kruskal-Wallis test as well aslinear mixed model for comparison of Hgb/ferritin improvement across IVI formulations, and Chi-squareanalysis as well as logistic mixed model for comparison of adverse effects.Results Our study included 344 patients, receiving a total of 661 IVI treatments [237(35.9%) iron sucrose (IS),226(34.2%) iron dextran (IDx), 155(23.4%) ferric carboxymaltose (FCM), 41(6.2%) ferric gluconate (FG),2(0.3%) ferumoxytol (FM)]. Limitations of this study include its retrospective nature and potentialselection bias. Prospective studies in children are needed to validate our findings."

Clinical • Celiac Disease • Chronic Kidney Disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Nephrology • Pediatrics

High dose iron infusions in pregnant women are effective, safe, and well-tolerated (ASH 2025) - "However, there has been a reluctance to prescribe the high doseiron formulations Ferric Derisomaltose (FDI) 1000mg or Ferumoxytol (FM) 510mg to pregnant women,because of a longer experience with iron sucrose (IS) 200mg... High dose iron infusions are effective, safe, and well-tolerated in pregnant women. In a largecohort study, symptom relief was found to be common and comparable for those with IDWA or IDA.Infusion reactions were rare, though they occurred more frequently with both FDI and FM compared toIS. Fewer post-infusion discomfort symptoms were observed after both FDI and FM than IS."

Clinical • Hematological Disorders • Immunology • Lumbar Back Pain • Musculoskeletal Pain

EASI-A: Early Antenatal Support for Iron Deficiency Anemia (clinicaltrials.gov) - P4 | N=80 | Recruiting | Sponsor: Thomas Jefferson University | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

DIVI: Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: University of Washington | Trial completion date: Dec 2027 ➔ Jun 2027 | Trial primary completion date: Dec 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

Decontrasted Image Registration Improves Quantification of Extracellular Volume and Fractional Myocardial Blood Volume. (PubMed, NMR Biomed) - "Patients with suspected myocardial diseases underwent cardiac MRI with Gadavist (0.1 mmol/kg, n = 11) and ferumoxytol (4.0 mg/kg cumulative, n = 9) enhancement for ECV and fMBV measurements, respectively...Overall, decontrasted image registration improves the precision of contrast-enhanced myocardial parametric mapping by reducing the misalignment between multicontrast images. This framework may be extended to other postprocessing tasks in cardiac MRI that involve variable image contrasts."

Journal

Contemporary Intravenous Iron Usage and Safety Patterns (ASH 2023) - "While all formulations are considered safe, those with iron dextran (ID) are reported to have a relatively higher incidence of anaphylaxis, often prompting a test-dose prior to full administration...Serious adverse events (SAEs) were defined as those events requiring epinephrine administration, anaphylaxis, hypotension, tachycardia, or an allergic reaction (hives, rash, chest tightness, eye swelling) within 24 hours of IV iron infusion... A total of 49,310 infusions were administered during the analyzed period and included the use of five formulations: ID, iron sucrose (IS), ferumoxytol (FM), ferric carboxymaltose (FC), and ferric gluconate (FG)... While ID was found to have a relatively higher incidence of AEs, all IV iron formulations were found to be safe. The most frequently used formulation was IS, which had a low incidence of AEs even at higher doses, suggesting feasibility for minimizing the number of infusions required to achieve therapeutic levels. Although all..."

Clinical • Cardiovascular • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hypotension • Nephrology • Obstetrics • Urticaria

Efficacy, Safety, and Tolerability of Iron Infusions in Pregnant Women: A Retrospective Chart Review (ASH 2023) - "Also, there has been reluctance to prescribe newer iron formulations including Ferric Carboxymaltose (FCM), Ferumoxytol (FM), and Ferric Derisomaltose (FDI)... Iron infusions in pregnant women are effective, safe, and well-tolerated when administered in an outpatient infusion center that has nurses trained to monitor pregnant patients carefully for infusion reactions. For pregnant women who have IDWA or IDA, the benefits of iron infusions likely outweigh the risks."

Retrospective data • Review • Anemia • Back Pain • Dermatology • Fatigue • Hematological Disorders • Hypotension • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Obstetrics • Pain • Urticaria

Hematology Electronic Consultation As a Means for Effective Management of Iron Deficiency Anemia (ASH 2023) - "The most common IV iron formulations were low molecular weight iron dextran (43%) and ferumoxytol (30%), and adverse reactions were rare occurring in only 3.3% of patients. The results from this analysis demonstrate that e-consults permit efficient and safe management of iron deficiency, improve access to hematology care, and generate cost savings for the healthcare system. With the growing utilization of e-consults for iron deficiency evaluation and management, wait times to initial hematology evaluation may improve while access to care is simultaneously increased. Future quality improvement efforts, such as standardizing note templates to document suspected etiology and automating follow-up labs at the time of iron infusion, should be considered to expedite appropriate workup, reduce risk of incomplete repletion and recurrence of iron deficiency, and optimize educational opportunities for ordering providers."

Anemia • Hematological Disorders

Overcoming the Obstacles That Prevent Identification and Treatment of Women Who Have Iron Deficiency (ASH 2023) - "These included Ferric Derisomaltose (1,055 infusions), Ferumoxytol (1,481 infusions), Iron Sucrose 200 mg doses (n=3,962 infusions), Iron Sucrose 400 mg doses (n=723 infusions), and Ferric Carboxymaltose (20 infusions)... Our hematology practice has overcome barriers to identifying women who have iron deficiency, and obstacles that prevent treatment with iron infusions. The solution to this problem involves educating women and women's health providers, and creating a system to plan and perform iron infusions promptly and safely."

Clinical • Anemia • Fatigue • Hematological Disorders • Women's Health

Longitudinal Systemic Bevacizumab Therapy Produces Cost Savings and Improves Quality-Adjusted Life Expectancy in the Care of Patients with Hereditary Hemorrhagic Telangiectasia with Moderate-to-Severe Bleeding (ASH 2023) - "Ferric carboxymaltose was used as the base-case iron supplement, and a scenario analysis examined ferumoxytol. By reducing the need for hemostatic procedures, hospitalizations, emergency visits, RBC transfusions, and iron infusions, bevacizumab is, unusually, a cost-saving intervention that also improves the quality-adjusted life expectancy of patients with HHT. Bevacizumab also saves patient time spent on receiving HHT-specific care. Collecting long-term follow-up data to evaluate continued response to bevacizumab will help assess its value versus future advances in the care of patients with HHT."

Clinical • HEOR • Anemia • Hematological Disorders • Hemophilia • Rare Diseases

A Case Of Refractory Iron Infusion Reactions (ACAAI 2025) - "Case Description A 41-year-old female with iron deficiency anemia in the setting of menorrhagia from uterine myoma and endometriosis presented to Allergy clinic for iron infusion reactions to intravenous ferric carboxymaltose, ferumoxytol, and iron sucrose...A 12-step desensitization with iron dextran was pursued in the ICU, but within minutes, she experienced similar anaphylaxis-like symptoms. With each reaction, her symptoms improved with intramuscular epinephrine, methylprednisolone, and antihistamines...She is currently being managed by hematology with tranexamic acid and oral iron supplements, with planned OB/GYN and gastroenterology follow-up to assess for colitis. Discussion Future steps for management of her anemia may include packed red blood cells, hormonal therapy, hysterectomy, 16-step desensitization with an alternative iron formulation, or biologics (e.g., omalizumab or dupilumab); however, the lack of diagnostic tools to delineate the mechanism complicates..."

Clinical • Anemia • Endometriosis • Gastroenterology • Gastrointestinal Disorder • Gynecology • Hematological Disorders • Immunology • Musculoskeletal Pain • Pulmonary Disease • Renal Disease • Uterine Leiomyoma • Women's Health

XACT-Fe-GBM-01: A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma (clinicaltrials.gov) - P1 | N=17 | Active, not recruiting | Sponsor: Bryan Allen | Trial completion date: Dec 2025 ➔ Dec 2026

First-in-human • Trial completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Ferumoxytol Pharmacokinetics in Cardiac Magnetic Resonance (AHA 2025) - "In pediatric patients with CHD, there is a marked increase in serum iron immediately after ferumoxytol infusion with return to baseline levels after several days. Ferumoxytol does not affect Ferritin levels. Transferrin levels and TIBC are normal or mildly decreased after infusion."

PK/PD data • Anemia • Cardiovascular • Heart Failure • Hematological Disorders • Pediatrics

Real-World Effectiveness of Intravenous Iron Therapy in HFrEF: A Multicenter Propensity-Matched Study (AHA 2025) - "IV iron exposure included iron sucrose, ferric carboxymaltose, ferric gluconate, ferumoxytol, iron dextran, and ferric derisomaltose. In this large, real-world cohort of HFrEF patients with iron deficiency, IV iron therapy reduced hospitalizations and inflammation (hs-CRP), with no effect on mortality or most cardiac outcomes. A modest increase in SVT and VT was observed. These findings support guideline recommendations for IV iron in HFrEF and highlight the need for arrhythmia monitoring."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Anemia • Atrial Fibrillation • Cardiomyopathy • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Myocardial Infarction • Renal Disease • Ventricular Tachycardia • CRP

Polysaccharide-Based Magnetic Nanoparticles in Brain Cancer: A Review on the Diagnostic and Therapeutic Potential of Ferumoxytol. (PubMed, Mini Rev Med Chem) - "Challenges in clinical translation, including dosage optimization and safety, require further investigation. This review highlights the potential of PSC-iron oxide nanoparticles in current findings to advance precision medicine or nanomedicine approaches for brain tumors."

Journal • Brain Cancer • Hematological Disorders • Immunology • Oncology • Solid Tumor

A NOVEL CASE OF VEGF-INHIBITOR THERAPY IN PULMONARY ARTERIAL HYPERTENSION DUE TO HEREDITARY HEMORRHAGIC TELANGIECTASIA (CHEST 2025) - "Her PAH was managed with subcutaneous treprostinil, macitentan, furosemide, and spironolactone, with significant symptomatic improvement despite ongoing severe PAH by hemodynamic measurements...Her anemia persisted despite intravenous ferumoxytol 1020 mg 1-2 times per week...This dysregulated BMP signaling pathway is the target of Sotatercept, the newest FDA-approved PAH therapy... The VEGF-inhibitor Bevacizumab has proven clinical benefits in HHT, yet there is no direct evidence supporting its use in PAH. This case demonstrates that Bevacizumab may be used safely in patients with PAH and HHT, and may improve PAH-specific metrics such as PASP, though further studies are needed to confirm its role in PAH."

Clinical • Anemia • Cardiovascular • CNS Disorders • Fatigue • Genetic Disorders • Hematological Disorders • Pulmonary Arterial Hypertension • Respiratory Diseases • ACVR2A • ACVRL1 • ALK1 • TGFB1

Ferumoxytol-Enhanced Cardiovascular Magnetic Resonance Imaging: Applications and Technical Advances. (PubMed, J Cardiovasc Magn Reson) - "In this review, we summarize the attributes of ferumoxytol, highlight promising research directions, and illustrate several growing ferumoxytol-enhanced CMR applications. We conclude with a discussion of safety."

Journal • Review • Cardiovascular

Ferumoxytol vs gadolinium based contrast for comprehensive MR angiography of the thorax: A feasibility study. (PubMed, Clin Imaging) - No abstract available

Journal

Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient (clinicaltrials.gov) - P3 | N=104 | Recruiting | Sponsor: Auerbach Hematology Oncology Associates P C | Trial completion date: Feb 2024 ➔ Feb 2026 | Trial primary completion date: Nov 2023 ➔ Nov 2025

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

Optimizing the Ferumoxytol dose for vascular suppression in brachial plexus magnetic resonance neurography. (PubMed, Phys Med Biol) - "Doses of 101.49 mg (17.81 mg-581.80 mg), 1.57 mg/kg (0.42 mg/kg-5.82 mg/kg), and 23.8 mg/L (5.88 mg/L-96.17 mg/L) were estimated to achieve the required diagnostic CRs of 0.2. Subject-specific Ferumoxytol dosing based on weight and estimated blood volume provided improved modeling and prediction of vascular suppression in brachial plexus MRN. This helps to optimize dose requirements, improve safety, while providing optimal vascular suppression needed for nerve visualization."

Journal

Iron-oxide nanoparticles selectively enhance the toxicity of pharmacological ascorbate through hydrogen peroxide-dependent DNA damage in non-small cell lung cancer (NSCLC). (PubMed, Free Radic Biol Med) - "The current study shows that 24 h pretreatment with an FDA-approved iron-oxide nanoparticle, Ferumoxytol (FMX), enhances the toxicity of P-AscH- in human NSCLC cells (H1299T and A549), but not in primary human bronchiolar epithelial cells (HBEpC). In H1299TCat15 cells engineered to overexpress doxycycline inducible catalase, FMX + P-AscH- also induced cell killing and carboplatin-induced radio-chemo-sensitization that was inhibited by exposure to doxycycline, demonstrating the dependence of the biological effects on H2O2...This study represents the first demonstration that FMX combined with P-AscH- selectively sensitize NSCLC cells (relative to normal cells) to ascorbate toxicity and chemo-radio-sensitization through enhancing H2O2-dependent DNA damage, that is accompanied by increased release of intracellular Fe2+. These results support the hypothesis that FMX can be used to selectively enhance therapy responses to P-AscH- in NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CAT