scholarly journals Safety and Efficacy of 1020 Mg Total Dose Infusion of Ferumoxytol in a Veterans Health System

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3538-3538
Author(s):  
Paige May ◽  
Preetika Pai ◽  
Katherine Boles ◽  
Ashley McGee ◽  
Jess David Delaune ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Health System ◽  
Total Dose ◽  
Veterans Health ◽  
Safety And Efficacy ◽  
Off Label ◽  
Iron Saturation ◽  
Dose Infusion ◽  
Infusion Reactions ◽  
Time Dose

Background Ferumoxytol (Feraheme) is an intravenous (IV) formulation of iron that can be infused quickly, making it a convenient choice. It is typically given in two doses of 510 mg. Auerbach and colleagues previously described utilizing a single dose of 1020 mg over 15 minutes safely and effectively (Am J Hematol 2013). A total dose infusion of 1020 mg has been described by experts in the field as the "maximum safe dose" (Auerbach and Adamson, Am J Hematol 2016). There exists very little published literature about the safety and efficacy of this off-label dosing, however it is an attractive administration schedule due to convenience of the one-time dose. In July 2018, we began to administer a single 1020 mg dose of feumoxytol to patients diagnosed with iron deficiency at the North Florida/South Georgia Veterans Health System (NF/SG VHS). The purpose of this review is to evaluate the impact of the use of the 1020 mg ferumoxytol dose to ensure safe, effective and efficient utilization in the management of iron deficiency anemia. Methods A retrospective chart review was conducted on patients who received ferumoxytol from February 1st, 2018 to January 31st, 2019 to capture approximately 6 months of data prior to and after the dosing strategy change. Patients were excluded from review if they had received IV iron within 3 months prior to the study period. Parameters collected included pre and post hemoglobin, iron saturation and ferritin concentrations, dose of iron given, frequency and number of infusions, post infusion monitoring time and hypersensitivity reactions. Our primary outcome was assessing safety, particularly the rate of infusion reactions for the entire cohort of patients. Secondary outcomes included efficacy and clinic utilization. Number of clinic visits, baseline and change in hemoglobin, ferritin and iron saturation following 1 dose of 1020 mg or 2 doses of 510 mg were compared using paired t tests. Rate of infusion reactions was compared between all patients who received either dose using Fisher's exact test. Results A total of 212 patients were screened and 140 included in analysis. 270 total doses of iron were given during the study period. Fifty nine patients (42%) received only 510 mg doses, 60 (43%) received only 1020mg doses and were included in the efficacy analysis. An additional 21 patients (15%) received both 510 mg and 1020 mg doses and were included in the analysis of reaction rate. Baseline characteristics were similar between the groups (see Table 1). Response to iron infusions were not significantly different between the dosing strategies. Mean change in hemoglobin was 1.96 g/dL for 510 mg group and 2.00 g/dL for the 1020 mg group (p=0.726). Mean change in ferritin was 114 ng/ml and 120 ng/ml, respectively(p=0.8203). Likewise, mean change in iron saturation was 13.6% and 14.3% (p=0.7808). The rate of infusion reactions was not increased with the higher dose (see Table 2), with only 1 reaction occurring in each group (0.57 % and 1.04 %, p=1.00). Both infusion reactions were able to be treated on an outpatient basis and the patients were discharged from the infusion clinic on the same day. Utilizing the 1020 mg dose significantly reduced the number of infusion room visits required, with an average of 2 visits for 510 mg patients and 1 visit for 1020 mg patients (p<0.0001). Conclusion Implementation of a total dose infusion of 1020 mg of ferumoxytol reduced the number of infusion room visits without increasing infusion reactions or compromising efficacy. This strategy could be considered at other institutions to improve infusion room access, patient convenience, and reduce costs. OffLabel Disclosure: Off label discussion concerns use of a one time dose of 1020mg of ferumoxytol as opposed to the labeled dose of 510 mg followed by a second dose 3 to 8 days later.

Rapid (Sixty Minutes) Infusion of One Gram of Low Molecular Iron Dextran: Safety and Efficacy Profile.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4054-4054 ◽  
Author(s):  
Michael Auerbach ◽  
Jennifer Pappadakis ◽  
Huzefa Bahrain ◽  
Sandra Forrester ◽  
Wendy Capitano ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Adverse Reactions ◽  
Multiple Drug ◽  
Iron Dextran ◽  
Safety And Efficacy ◽  
Off Label ◽  
Dose Infusion ◽  
History Of ◽  
Iv Iron

Abstract Abstract 4054 Poster Board III-989 Introduction Many clinical situations are associated with the development of iron deficiency which can adversely affect energy level, physical activity, cardiovascular function, cognition, and immune responses. Oral iron, which is the primary treatment for iron deficiency, is limited by poor tolerability due to gastrointestinal (GI) side effects and resulting problems with compliance. In addition, in many patients it is not easily absorbed and does not replace iron stores rapidly enough to meet iron losses. Blood transfusions may be avoided in these patients with the use of intravenous (IV) iron. Whereas other forms of IV iron require multiple doses for complete replacement, LMWID may be administered as a total dose infusion, typically over a 4 to 6 hour period. LMWID (INFeD) is the preferred iron dextran due to the lower incidence of reported adverse reactions in the literature as compared to high (H) MWID, (DexFerrum). Numerous clinical studies of IV iron suggest that 1000 mg is an adequate dose for many patients. Our clinical practice routinely administers LMWID as a 1 g infusion over 1 hour without pre-medication. We summarize our experience with the safety and efficacy of this method of administration. Patients and Methods Data were collected for consecutive adult patients with iron deficiency who were treated with 1 gram of LMWID from August 2008 to May 2009. To avoid confounding variables patients who received erythropoiesis stimulating agents or chemotherapy were excluded from the analysis. Age, gender, height, weight, diagnosis, tests of iron status (serum ferritin, total iron binding capacity, serum iron, and percent transferrin saturation), hemoglobin (Hb), history of multiple drug allergies and/or iron allergies, dose of iron dextran, infusion rate, number of transfusions, and signs or reports of adverse reactions were recorded. As clinically important hypophosphatemia (serum phosphate <2mg/dL) has been reported with several IV iron preparations, we examined pre- and post-infusion phosphate levels. Results 189 consecutive iron deficient patients (84% female, 76% white, mean age = 51 years, mean weight = 85 Kg) were included in the analysis, 15.9% of whom had multiple drug allergies (≥ 2). The most common diagnoses were: menorrhagia, chronic kidney disease, angiodysplasia, pregnancy, GI bleed, and gastric bypass; 19% of patients had multiple diagnoses. A total of 224 1-gram doses were administered over a median infusion time of 63 minutes (interquartile range 60-66 min). No pre-medication was administered except for 1 dose of methylprednisolone prior to the test dose in each of 2 patients: one with a previous reaction to HMWID, and one with drug allergies. Following administration of LMWID, there was a significant increase from baseline in Hb of 1.2 g/dL (p <0.0001, 95% confidence interval [CI]: 1.0 to 1.4) with a median follow-up time of 3 weeks. A follow-up time of ≥ 4 weeks was associated with a greater increase in Hb than < 4 weeks (1.5 vs 1.0 g/dL, p=0.013). One patient required a transfusion following severe GI bleeding secondary to angiodysplasia. Nineteen patients (10.1%) experienced 33 adverse events (AEs). The AEs were considered treatment-related in12 patients (6.3%). The most common AEs were back pain (2.6%), headache (2.1%), and nausea (1.6%). AEs were mostly transient and resolved without therapy. Five (2.6%) patients were treated for minor reactions (3 patients received 125 milligrams of methylprednisolone during or immediately following the infusion, and 2 patients received acetaminophen). There were no serious AEs, and only 1 patient discontinued treatment due to an AE (hives). The only demographic factor that was independently associated with an increased likelihood of experiencing an AE was drug allergies. Patients with a history of > 2 drug allergies were 4.3 times more likely to experience any kind of AE than other patients (95% CI: 1.1 to 16.3, p=0.031). Mean change from baseline phosphate level was 0.0 mg/dL (95% CI: -0.1 to 0.2, p=0.537) at a median follow-up time of two weeks. No patient developed hypophosphatemia. Conclusions Our single center experience found IV administration of 1 gram of LMWID over 1 hour is a safe and effective treatment for patients with iron deficiency with the advantages of shorter treatment period, assured compliance, and a lower incidence of side effects than oral iron. Future prospective, randomized studies will help confirm these findings. Disclosures: Off Label Use: The total dose infusion of low molecular weight iron dextran, although widely used, is an off label method of administration of intravenous iron. Pappadakis:Watson Laboratories: Employment. Dahl:Watson Laboratories: Employment.

scholarly journals Safety and efficacy of a single total dose infusion (1020 mg) of ferumoxytol

2021 ◽  
Vol 12 ◽  
pp. 204062072110060
Author(s):  
Harris Khan ◽  
Paige May ◽  
Elim Kuo ◽  
Preetika Pai ◽  
Katherine Boles ◽  
...  
Keyword(s):  
Single Dose ◽  
Total Dose ◽  
Treatment Option ◽  
Deficiency Anemia ◽  
Utilization Review ◽  
Veterans Health ◽  
Significant Difference ◽  
Dose Infusion ◽  
Iv Iron ◽  
The Impact

Purpose: Iron deficiency anemia (IDA) is the most common type of anemia. A single dose infusion of intravenous (IV) iron is a convenient treatment option. Ferumoxytol is an IV formulation of iron that is typically given in two doses of 510 mg each. Utilizing a single dose of 1020 mg over 15 min has previously been described as safe and effective. In July 2018, we began to administer a single 1020 mg dose of ferumoxytol to patients needing IV iron replacement at the North Florida/South Georgia Veterans Health System. To evaluate the impact of this change, a utilization review was conducted. Methods: Outcomes of all patients who received ferumoxytol injections in the 6 months prior to and after the dosing strategy change were analyzed. A total of 140 patients, who received 270 separate IV ferumoxytol infusions, were included in the analysis. Results: No significant difference in safety was observed, with one infusion reaction occurring in each group ( p = 1.00). Efficacy also appeared equivalent with no significant difference between the change in hemoglobin for those who received a single 1020 mg dose versus those who received two 510 mg doses ( p = 0.764). As expected, those who received a single total dose infusion of 1020 mg had less clinic utilization ( p < 0.0001). Conclusion: In summary, ferumoxytol administered as a 1020 mg single dose infusion was more convenient and should be considered a safe and effective treatment option for IDA.

Safety and Efficacy of Total Dose Iron Dextran Administration in Patients on Home Renal Replacement Therapies

1998 ◽  
Vol 18 (5) ◽  
pp. 522-527 ◽  
Author(s):  
James A. Sloand ◽  
Mark A. Shelly ◽  
Anne L. Erenstone ◽  
Melissa J. Schiff ◽  
Thomas E. Talley ◽  
...  
Keyword(s):  
Renal Replacement Therapy ◽  
Total Dose ◽  
Replacement Therapy ◽  
Delayed Response ◽  
Low Grade ◽  
Iron Dextran ◽  
End Points ◽  
Safety And Efficacy ◽  
Iron Saturation ◽  
Esrd Patients

Objective To determine the safety and efficacy of intravenous total dose iron (TDI) replacement in patients treated with home renal replacement therapy. Design Prospective open-label study on end points in the population studied. Setting Institutional outpatient home dialysis program. Patients The study included 20 end-stage renal disease (ESRD) patients, performing chronic peritoneal or home hemodialysis, with iron deficiency defined as ferritin < 100 ng/mL and/or an iron saturation < 20%. Intervention The total dose of iron dextran was calculated and infused at a rate not exceeding 6 mg/min. Hemoglobin, hematocrit, iron studies, and liver function tests (LFTs) were obtained before and 3 to 4 weeks after TDI infusion. Hematocrit of patients failing to achieve an increase in Hct over this period was re-examined 2 to 4 weeks later looking for a delayed response. Main Outcome Measures Primary end points for efficacy were changes in Hct, ferritin, and iron saturation. Toxicity was measured as reported immediate and delayed symptoms and elevated transaminases and/or alkaline phosphatase levels. Results A median iron dose of 1000 mg (range, 325 1500 mg) was administered. The infusions were generally well tolerated. Clinical adverse effects were seen in 2 patients weighing less than 50 kg. No increase in LFT results was seen. Hematocrit increased 2.2% (95% CI, 0.5% -3.9%) from 29.0% to 31.2% (p = 0.01) within 4 weeks of infusion. Significant increases also occurred in iron saturation (from 13% to 22%, p = 0.001) and ferritin (from 234 to 305 ng/mL, p = 0.008). Among the 9 patients who did not respond with a significant increase in Hct, 2 had a delayed response, increasing the overall response from 63% at 4 weeks to 71 %,8 weeks after TDI.lnadequate erythropoietin dosing and low-grade infectious/inflammatory disorders may have contributed to a poor response in several patients. Conclusion Total dose iron is a safe and effective means of restoring iron and erythropoietic response in ESRD patients weighing more than 50 kg who receive their renal replacement therapy at home.

scholarly journals Increased Hepatic Iron Stores in the Human Fetus after Maternal Total Dose Infusion of Iron Dextran

1982 ◽  
Vol 19 (4) ◽  
pp. 238-240 ◽  
Author(s):  
B B Bauminger ◽  
G Walters
Keyword(s):  
Iron Deficiency ◽  
Chemical Analysis ◽  
Total Dose ◽  
Human Fetus ◽  
Histochemical Method ◽  
Hepatic Iron ◽  
Iron Dextran ◽  
Iron Stores ◽  
Dose Infusion

The results are presented of the chemical and histochemical assessment of the hepatic iron stores in two babies stillborn after treatment of iron deficiency in the mother by a total dose infusion of iron dextran. The levels of storage iron in the liver determined by chemical analysis were much higher than in six other stillborn babies whose mothers had not been so treated. This difference was not demonstrable by a histochemical method.

The Safety and Efficacy of Total Dose Infusion of 1020 Mg of Ferumoxytol Administered in 15 Minutes

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1042-1042
Author(s):  
Michael Auerbach ◽  
Stella Rineer ◽  
Huzefa Bahrain ◽  
Sarah A Auerbach
Keyword(s):  
Total Dose ◽  
Intravenous Iron ◽  
Deficiency Anemia ◽  
Published Data ◽  
Inadequate Response ◽  
Post Dose ◽  
Safety And Efficacy ◽  
Phone Calls ◽  
Dose Infusion ◽  
The Mean

Abstract Abstract 1042 Title: The safety and efficacy of total dose infusion of 1020 mg of ferumoxytol administered in 15 minutes Background: For the past two years, it has been our standard to treat iron deficiency anemia (IDA) with intravenous iron (low molecular weight iron dextran) administered as a total dose infusion (TDI) of 1 g over one hour. We recently published our experience with 1266 such infusions administered to 888 patients, in whom no serious adverse events (SAEs) were reported (AJH, in press by ). In June 2009, ferumoxytol (FER) was approved for the treatment of IDA in adults with chronic kidney disease, administered as 2 × 510 mg boluses in less than 1 minute, separated by 3 to 8 days, for a total dose of 1020 mg. After administering >300 510 mg doses per label, we sought to explore the potential convenience for clinics and patients of delivering the full dose at a single administration. Methods: This was a single-arm, open-label, single-center clinical trial conducted under an investigator IND with IRB approval. A total of 30 patients with IDA (Hgb <11g/dL, ferritin <100 ng/mL, TSAT <19%) and a history of intolerance of or inadequate response to oral iron received 1020mg (34ml) of FER diluted in 100 mL normal saline via infusion pump in 15 minutes. Patients with anemia due to another cause, active use of epoetin, parenteral iron therapy in the prior 30 days or known sensitivity to FER were excluded. Vital signs were measured for one hour post-dose, and phone calls were made at 1, 2, and 7 days post-dose to assess AEs; efficacy assessments (Hgb, TSAT, ferritin, RDW) occurred at 4 and 8 weeks post-dose. The primary endpoint was the safety and tolerability, while secondary efficacy endpoints included mean change in Hgb and TSAT from baseline to week 4. Results: At the time of submission, the trial remains ongoing and has enrolled 24 of 30 IDA patients. Of these, 9 patients have completed the Week 4 assessments. These preliminary results are presented below; complete results from all 30 patients will be available by the time of presentation. For the 24 enrolled patients, the mean age was 51 years (range 24–80 years). Eighty-three percent (83%) were female, while 79% were white and 21% black. The most common associated diagnoses were gastric bypass and menorrhagia (both 33%). There were no SAEs. One patient discontinued due to flushing, which resolved in 2 minutes without treatment. Minor AEs were experienced by 12 of 24 patients (50%), with the most common being headache (17%), arthralgia/myalgia/cramps (17%), and mild nausea (13%). All of these AEs were self-limited and resolved without therapy. Consistent with previously published data, 4 of the 12 subjects who experienced AEs had a known medication allergy. The mean Hgb (N=24) prior to treatment was 9.3 g/dL, while the mean Hgb at week 4 (N=8) was 11.4 g/dL. Of the 8 evaluable patients at week 4, the mean change from baseline was 2.0 g/dL; 7 of 8 patients (87%) had a >1 g rise in Hgb from baseline to week 4. All 8 patients with week 4 data had elevated RDWs, reflective of an ongoing hematopoietic response. Conclusions: FER administered as a TDI of 1020 mg TDI in 15 minutes was well tolerated and effective in patients with IDA with a variety of underlying conditions. If confirmed through randomized controlled studies, TDI administration of intravenous iron provides a more convenient method for the treatment of IDA for both physicians and patients. Disclosures: Off Label Use: Total dose iron replace with 1020 mg of ferumoxytol in 15 minutes (under auspices of FDA IND 112001).

Safety and Efficacy of Total Dose Infusion of Low Molecular Weight (LMW) Iron Dextran in a Large Population of Anemic Patients Across a Broad Spectrum of Diagnoses Associated with Iron Lack

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4028-4028 ◽  
Author(s):  
Tahir Mehmood ◽  
Khine Swe ◽  
Gopimohan Das ◽  
Aysegul Gozu ◽  
Michael Auerbach ◽  
...  
Keyword(s):  
Total Dose ◽  
Large Population ◽  
Transferrin Saturation ◽  
Laboratory Data ◽  
High Dose ◽  
Inadequate Response ◽  
Iron Dextran ◽  
Safety And Efficacy ◽  
Iron Deficient ◽  
Dose Infusion

Abstract Background: Physicians are reluctant to recommend high dose intravenous (IV) iron infusion for iron deficient (ID) patients due to concerns of adverse events (AEs) including anaphylaxis. This retrospective analysis evaluates efficacy and AEs with LMW iron dextran (ID) total dose infusion (TDI) in patients with iron deficiency. Methods: We retrospectively evaluated the Electronic Medical Records of 468 consecutive patients with iron deficient anemia (IDA) who received IV LMW ID between 01/2008 and 07/2011 in an ambulatory infusion center. Diagnostic parameters for IDA included hemoglobin [Hgb] <11 g/dL, transferrin saturation [TSAT] 19%, ferritin <100 ng/mL. The majority had documented intolerance of or inadequate response to oral iron. All received TDI of LMW ID (1130 ± 217 mg) over 1 hour after a test dose of 25 mg. Pre-medication was not used. Patients were closely monitored for AEs during and immediately after infusions. Laboratory data for baseline and repeat hematological parameters within 8 weeks following infusions were analyzed. End points were safety and efficacy. Safety data was available for all 468 patients. Follow-up data at 8 weeks was available on 315. Figure 1 Figure 1. Results: There were 103 males and 365 female patients. Most common diagnoses were GI bleed, chemotherapy, menorrhagia and chronic kidney disease. At baseline, mean Hgb was 9.8 g/dL, ferritin 92.08ng/mL, and TSAT 12.37%. At 8 weeks the mean hemoglobin increased to 10.97 g/dL (p =0.0001), Ferritin 279.63 ng/mL (p =0.0001), and TSAT 21.85% (p=0.0001). All tolerated the infusion well. There were no incidents of fever, chills, wheezing, hypotension, stridor, periorbital edema, anaphylaxis or death. One complained of chest tightness, but completed the infusion after several minutes and the administration of diphenhydramine and steroids. One developed a rash. Fatigue and myalgia were reported in 17.31% and 8.33% of patients respectively. Conclusions: This study demonstrates TDI of LMW ID can be given safely and conveniently over 1 hour in an outpatient setting without premedication to ID patients. Easily manageable minor reactions did not affect the therapeutic plan. No allergic or anaphylactic reactions were observed. This study demonstrated TDI of LMW ID improved hemoglobin levels more than 1 g/dL within 8 weeks. Consistent with the preponderance of published evidence TDI of LMW ID should be considered an important therapeutic option for iron replacement in patients with IDA. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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