Intravenous Iron Monotherapy for Absolute and Functional Iron Deficiency Anemia in Cancer Patients

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 5167-5167
Author(s):  
Sara Hiller ◽  
Jeffrey Gilreath ◽  
David Stenehjem ◽  
Daniel S. Sageser ◽  
George M Rodgers
Keyword(s):  
Molecular Weight ◽  
Iron Deficiency ◽  
Total Dose ◽  
Cancer Patients ◽  
Response Rate ◽  
Deficiency Anemia ◽  
Low Molecular Weight ◽  
Iron Dextran ◽  
Iv Iron ◽  
Low Molecular Weight Iron

Abstract Abstract 5167 Objective Iron deficiency anemia (IDA) is common in cancer patients. The Hemoglobin (Hb) response rate in cancer patients with IDA who receive an erythropoiesis stimulating agent (ESA) ranges from 25 – 65% and is increased to 68 – 93% when intravenous (IV) iron is added to the ESA. Interestingly, there have been no studies to date that have evaluated Hb response to IV iron monotherapy for the treatment of IDA in cancer patients. The National Comprehensive Cancer Network (NCCN) recommends treating absolute IDA (AIDA, serum ferritin < 30 ng/mL and TSAT < 15%) with iron monotherapy, preferably IV. However, the NCCN recommends that functional IDA (FIDA, serum ferritin ≤ 800 ng/mL and TSAT < 20%) be treated with both IV iron plus an ESA. Unfortunately, ESAs carry black box warnings for increased mortality, cancer progression, and venous thromboembolism. Therefore, it is important to explore other ways to more safely treat IDA in cancer patients. The objective of this study was to evaluate the Hb response rate to IV iron monotherapy in cancer patients with AIDA and FIDA. Methods A retrospective chart review was performed at the Huntsman Cancer Institute between January 2006 and June 2011 in cancer patients with AIDA or FIDA who were treated with low molecular weight iron dextran (LMWID) monotherapy. Patients were excluded if they had a ferritin > 800 ng/mL or TSAT ≥ 20%, received an ESA within 6 weeks prior to or within 4 weeks after the LMWID infusion, or received a packed red blood cell transfusion prior to the LMWID infusion without a documented post- transfusion, pre-LMWID infusion Hb. The primary outcome was the proportion of patients with a Hb response defined as an increase of at least 1 g/dL within 6 weeks post IV iron infusion. The secondary outcome was the Hb response within 6 weeks stratified by dose of IV iron. Results Two hundred patients received LMWID at our institution within the specified time period. However, 182 patients were excluded because they did not have active cancer, did not have a definitive diagnosis of AIDA or FIDA, or received concomitant therapy with an ESA. Eighteen patients with either a hematologic or solid malignancy were included. Thirteen patients had AIDA and 5 patients had FIDA. Eight of the 13 (62%) patients in the AIDA group had a Hb response. The median Hb increase in the AIDA group was 1. 3 g/dL (p < 0. 0001). A Hb response was observed in 4 of the 5 (80%) patients in the FIDA group. The median Hb increase in the FIDA group was 1. 8 g/dL (p = 0. 0224). Of the 8 patients with AIDA achieving a response, 4 received less than and 4 received more than the calculated total IV iron dose (equation per package insert). Of the 4 patients achieving a Hb response in the FIDA group, 3 received less than and 1 received equal to the calculated total dose. The overall Hb response rate to IV iron monotherapy for both groups was roughly 67% which is greater than the Hb response rate reported with ESAs alone. See Table 1 for individual patient details. Conclusion Although our study has limited patient numbers, this is the first data suggesting that IV iron without an ESA may be an effective treatment for both AIDA and FIDA in anemic patients with a variety of malignancies. IV iron monotherapy may eliminate the need for an ESA. This hypothesis should be tested in larger studies. Disclosures: Off Label Use: The total dose infusion of low molecular weight iron dextran is not an FDA approved dosing regimen. However, it is commonly used in practice and has been used in other studies. Rodgers:American Regent: Consultancy.

Iron Deficiency Anemia: Safety and Cost-Effectiveness of Treatment with Various Intravenous Iron Preparations

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4661-4661
Author(s):  
Michael F Driscoll ◽  
Derek Forster ◽  
Brandi Dyer ◽  
Damian A. Laber
Keyword(s):  
Molecular Weight ◽  
High Molecular Weight ◽  
Intravenous Iron ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Low Molecular Weight ◽  
Iron Dextran ◽  
Life Threatening ◽  
Iv Iron ◽  
Low Molecular Weight Iron

Abstract Introduction: Iron deficiency anemia is one of the most commonly encountered hematologic medical conditions in general practice. Oral replacement of iron can be a slow and suboptimal process, limited by low absorption rates and disease-enhanced malabsorption. When clinicians are faced with patients with large iron deficits, intravenous (IV) iron is the best option. Currently there are four IV preparations available; iron sucrose, iron gluconate, low-molecular weight iron dextran and high-molecular weight iron dextran. Upon informal questioning, we found reluctancy by many physicians to use iron dextran due to fear of allergic reactions. We examine these four preparations for clinical utility, adverse drug events (ADEs), and cost-effectiveness. Methods: We performed a systematic review and retrospective meta-analysis of studies investigating various forms of intravenous iron preparations for toxicity, ADEs, and costs. Also, we obtained actual costs of infusing intravenous iron at four hospitals in metro Louisville, KY. Results: Fourteen studies met the criteria and were reviewed. One study compared all four iron preparations, two compared three preparations and the rest compared two. Eight had a small sample size. The number of ADEs were quite small. Data from FDAderived ADE reporting of the four IV iron preparations from 2001–2003 showed a total of 1141 per 30,063,800 doses administered, yielding an ADE rate of approximately 38 per million. Absolute rate of all ADEs for iron sucrose, iron gluconate, low molecular weight iron dextran and high molecular weight iron dextran were 19.2, 18.5, 36.9, and 117.8 per million, respectively. Absolute rates of life-threatening ADEs were significantly lower at 0.6, 0.9, 3.3, and 11.3 per million respectively for iron sucrose, iron gluconate, low molecular weight iron dextran, and high molecular weight iron dextran. Based on cost differences between iron sucrose and dextran preparations, the cost to prevent one lifethreatening ADE related to the use of lower molecular weigh iron dextran was estimated to be $5.0–7.8 million. Also the cost to prevent one low-molecular weight iron dextran related death was estimated to be $33 million. These calculations are based on cost of preparations only. Estimates based on hospital-related costs incurred due to multiple infusions vs total dose infusion (TDI) puts the estimate of cost to prevent one lower molecular weight related death over $150 million. Conclusions: The perceived rate of ADEs related to infusion of IV iron preparations in medical practice has been overstated. Smaller studies with lower patient and total infusion numbers, and anecdotal evidence, tended to overestimate the frequency of life-threatening reactions. The incidence of ADEs and serious life-threatening ADEs, is exceedingly low for all IV iron preparations. In light of costs associated with the use of iron sucrose and iron gluconate vs iron dextran, we recommend that all clinicians re-assess the clinical utility of low molecular weight iron dextran for iron deficiency anemia necessitating parenteral iron replacement. Moreover, large doses of iron dextran can be safely given, thereby reducing costs associated with multiple small infusions of iron sucrose.

scholarly journals Efficacy and Safety of Low Molecular Weight Iron Dextran (LMWID) Vs. Ferumoxytol in Treating Iron Deficiency Anemia

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2449-2449
Author(s):  
Arpine Khudanyan ◽  
Sven Reid Olson ◽  
Thomas G. Deloughery ◽  
Joseph J Shatzel
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Retrospective Cohort ◽  
Deficiency Anemia ◽  
Low Molecular Weight ◽  
Iron Dextran ◽  
Efficacy And Safety ◽  
Arm Swelling ◽  
Iv Iron ◽  
Low Molecular Weight Iron

Introduction: Iron deficiency anemia is the most common form of anemia and hematologic problem worldwide. Treatment options include oral or intravenous (IV) iron replacement. Although oral iron is commonly employed as first-line therapy, many studies suggest that IV iron more effective and associated with better quality of life when compared to oral iron. Yet, adverse infusion reactions are possible. Several forms of IV iron are used in clinical practice, including low molecular weight iron dextran (LMWID), ferumoxytol, ferric gluconate, iron sucrose, and ferric carboxymaltose. We sought to compare the efficacy and safety of LMWID and ferumoxytol, the two most frequently used products at our center. Methods: A retrospective cohort analysis was conducted using internal pharmacy records. Adults with an ICD-10 diagnosis of iron deficiency anemia treated with LMWID or ferumoxytol from 2018 to 2019 were identified. Records were reviewed for demographics, comorbidities, allergies, type and frequency of iron administered. Outcomes of interest were comparisons of baseline and post-treatment hemoglobin [Hgb] and ferritin levels and adverse events (AEs) following infusion. Results: In total 55 patients received one of the two included iron preparations. Of the 40 cases of iron deficiency treated with LMWID, only 4 patients (10%) received a second dose. Of the first LMWID infusions (dose of 1000 mg), all patients demonstrated an increase in Hgb from a mean of 12.21 to 13.15 within an average of 2.75 months. Mean ferritin levels went from 28.34 pre-treatment to 231.14 post-treatment, within an average of 3.26 months. 2 patients (5%) received premedication, one with diphenhydramine or promethazine, based on prior history of an AE. AEs were documented in 3 patients (7.5%) and included arm swelling, dysphagia with globus sensation, and nausea. No patients received premedication prior to ferumoxytol infusion. Those receiving ferumoxytol demonstrated an increase in hemoglobin from a mean of 10.25 to 12.17 within an average of 4.2 months. Ferritin increased from baseline 75.93 to 150.33 within 3 months. AE of diarrhea and nausea were reported in only one patient (6.67%) upon second infusion of ferumoxytol. No patient in either group experienced AEs requiring hospitalization, nor did any patient develop severe hypersensitivity reactions, hypotension, or hypophosphatemia. Discussion: In our retrospective cohort, LMWID or ferumoxytol for treatment of iron deficiency were well tolerated with minimal AEs, limited to arm swelling, dysphagia and nausea in 3 patients. Those treated with ferumoxytol experienced similarly few AEs, with only one patient developing transient diarrhea and nausea. Hesitancy to utilize IV iron has persisted due to concerns for potential side effects including anaphylaxis. Our encouraging results provide additional evidence for the efficacy and safety of LMWID and furomoxytol, and should help to assuage fears that IV iron might be poorly tolerated or ineffective. Disclosures Shatzel: Aronora, Inc.: Consultancy.

Intravenous low molecular weight iron dextran in children with iron deficiency anemia unresponsive to oral iron

2013 ◽  
Vol 60 (11) ◽  
pp. 1747-1752 ◽  
Author(s):  
Ellen S. Plummer ◽  
Shelley E. Crary ◽  
Timothy L. McCavit ◽  
George R. Buchanan
Keyword(s):  
Molecular Weight ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Low Molecular Weight ◽  
Iron Dextran ◽  
Low Molecular Weight Iron

Intravenous Low Molecular Weight Iron Dextran (LMWID) in the Treatment of Children with Iron Deficiency Anemia,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3184-3184
Author(s):  
Ellen S. Plummer ◽  
Shelley E. Crary ◽  
George R. Buchanan
Keyword(s):  
Molecular Weight ◽  
Single Dose ◽  
Blood Loss ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Iron Dextran ◽  
Oral Iron Therapy ◽  
Iv Iron ◽  
Low Molecular Weight Iron

Abstract 3184 Background: While iron deficiency anemia (IDA) is among the most common hematologic disorders during childhood, management strategies for patients poorly responsive to oral iron therapy have not been well studied. Children treated for IDA often have a poor response to oral iron due to noncompliance, intolerance of side effects, malabsorption, ongoing blood loss, or a combination of these factors. Alternative treatment approaches are therefore needed. Intravenous (IV) iron, including low molecular weight iron dextran (LMWID), offers the possibility of correcting the anemia and repleting iron stores using a single dose, potentially decreasing the overall burden of treatment. Use of LMWID in children has been limited due to concerns about anaphylaxis associated with high molecular weight iron dextran preparations, even though in adults the risk of anaphylaxis is decreased when alternative IV iron preparations, including LMWID, are employed. In this study we report our initial experience with LMWID in children with IDA. Methods: We performed a retrospective record review of patients receiving IV LMWID for IDA in the Center for Cancer and Blood Disorders at Children's Medical Center Dallas between December 1, 2010 and July 31, 2011. Records were reviewed for age, indication for LMWID, concurrent medical problems, use of premedication, initial and follow-up hemoglobin values, adverse events (AEs), and prior or subsequent receipt of other IV iron preparations. The primary study aim was to characterize the clinical course of patients receiving LMWID to inform a planned prospective cohort study of IV iron in children with IDA poorly responsive to oral iron therapy. Results: A total of 18 patients, age 11 months (mos) to 18 years (yrs), received IV LMWID during the study period. 11 of them (median age 13 yrs) received LMWID for IDA secondary to external blood loss due to menorrhagia (n=3), gastrointestinal disease (n=3), hemophilia (n=2), Von Willebrand disease (n=2), and immune thrombocytopenia (n=1). Five (median age 2 yrs) had IDA due to nutritional deficiency, and two patients had multiple causes for their IDA. 14 patients (77.8%) received their initial LMWID infusion without AEs, and all demonstrated an increase in hemoglobin (mean 3 g/dL) 4 to 7 weeks following infusion. Premedication with diphenhydramine, acetaminophen, hydrocortisone, or a combination of these was given to 6 of the 14 patients (42.8%) at the discretion of the treating physician based on history of atopy. The average dose of LMWID was 600 mg (20.2mg/kg) with a range of 150 mg to 1 gram (6.9 mg/kg to 30.9 mg/kg). 3 of these 14 patients (21.4%) required a subsequent infusion to achieve and maintain a normal hemoglobin due to ongoing blood loss. 6 patients (33.3%) had transient AEs during LMWID infusion including hives (n=3), tachycardia (n=2), chest tightness (n=1), fever (n=2), nausea (n=1), vomiting (n=1), sweating (n=2), and cough (n=1). 2 of them were able to complete the infusion without further sequelae after receiving diphenhydramine or hydrocortisone. Only one of the patients with AEs had received premedication, although on review 3 of the 6 patients with AEs had a concurrent medical problem affecting immune function including asthma and orthotopic liver transplant. No patient required hospital admission or treatment of the AE beyond the day of their clinic visit. 4 of the 6 patients with AEs related to LMWID subsequently received IV iron sucrose infusions without any complications. Conclusions: Among 18 children with IDA receiving LMWID planned as a single dose infusion, treatment was well tolerated and effective in 14 of them and associated with only transient AEs in 6. The latter patients were able to either receive the remainder of the LMWID infusion or an alternative iron preparation without complication. Some patients with ongoing blood loss needed additional infusions, although the majority of children were treated effectively with a single dose. These encouraging results support the need for further study of LMWID in children with IDA unresponsive to oral iron therapy or even as an initial treatment alternative to the oral route. Disclosures: No relevant conflicts of interest to declare.

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