scholarly journals Persistent Hypophosphatemia after Ferric Carboxymaltose Is Associated with Persistent Changes in Biomarkers of Bone Metabolism

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 13-14
Author(s):  
Myles Wolf ◽  
Benedikt Schaefer ◽  
Heinz Zoller
Keyword(s):  
Bone Metabolism ◽  
Bone Health ◽  
Research Funding ◽  
Case Reports ◽  
Serum Phosphate ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
High Dose ◽  
Iv Iron ◽  
Bone Complications

Introduction High-dose intravenous (IV) iron formulations are used to correct iron-deficiency anemia in patients when there is a clinical need to deliver iron rapidly or to treat patients who do not tolerate or fail to respond to oral iron. Hypophosphatemia is an important adverse effect of some IV iron formulations. Persistent hypophosphatemia is associated with bone complications, including osteomalacia. In two recent head-to-head trials, ferric carboxymaltose (FCM) induced marked increases in the phosphaturic hormone fibroblast growth factor 23 (FGF23), which led to significantly higher rates of incident and persistent hypophosphatemia than in patients treated with ferric derisomaltose (FDI) (Wolf et al. JAMA. 2020;323:432-43). Here, we present a post hoc analysis of patients with incident hypophosphatemia in which we investigated predictors of persistent hypophosphatemia and tested whether persistent hypophosphatemia was associated with persistent changes in biomarkers of bone metabolism, which could help explain bone complications that have been linked to FCM in numerous case reports. Methods We analyzed pooled data from two open-label, randomized clinical trials that compared the US dosing of FCM (2 doses of 750mg administered 1 week apart; N=117) to FDI (1 dose of 1000mg; N=125). In this analysis only patients who developed incident hypophosphatemia (serum phosphate <2.0 mg/dL) after treatment were included. This subgroup was then classified according to their serum phosphate at the end of the trials' observation period on day 35 as either 'recovered' (≥2.0 mg/dL) or 'persistent' (<2.0 mg/dL). We used multivariate logistic regression analyses with forward stepwise selection to identify baseline predictors of persistent hypophosphatemia. To better understand the effects of persistent hypophosphatemia on bone health, we compared changes in biomarkers of bone metabolism in patients who developed persistent hypophosphatemia with those who recovered from hypophosphatemia. Results Overall, 90 patients (FDI, n=8; FCM, n=82) who developed incident hypophosphatemia were classified as 'recovered' or 'persistent'. All 8 patients who developed hypophosphatemia after FDI recovered. In the FCM group, hypophosphatemia recovered in 43% of patients (n=35) and persisted in 57% (n=47). Besides FCM use, no baseline predictor could independently distinguish patients who developed hypophosphatemia and recovered from patients who experienced persistent hypophosphatemia. Within the FCM group, patients who developed persistent hypophosphatemia had greater increases in intact FGF23 on day 8 compared to patients who recovered (mean change from baseline to day 8 [95% CI]: 471.3 pg/mL [402.7 to 539.9] vs 228.3 pg/mL [186.8 to 269.9]). Compared to patients who recovered from hypophosphatemia, patients in whom hypophosphatemia persisted also had significant and persistent differences in multiple biomarkers at study end on day 35 (mean change from baseline to day 35 [95% CI]): increased intact FGF23 (58.7 pg/mL [40.8 to 76.5] vs -0.1 pg/mL [-6.7 to 6.5); increased parathyroid hormone (38.6 pg/mL [26.6 to 50.5] vs 14.5 pg/mL [4.5 to 24.5]); decreased 1,25-(OH)2-vitamin D (-35.1 pg/mL [-39.1 to -30.9] vs -3.4 pg/mL [-8.5 to 1.7]); and decreased N-terminal pro-peptide of type 1 collagen (-22.5 ng/mL [-26.3 to -18.6] vs -6.1 ng/mL [-11.1 to -1.1]). Conclusion Persistent hypophosphatemia developed only in patients who received FCM. Baseline characteristics could not discern whether patients with incident hypophosphatemia would remain persistently hypophosphatemic or go on to recover by study end. Persistent hypophosphatemia resulted in similarly persistent changes in biomarkers of bone metabolism. These findings suggest that treatment with FCM may affect bone health, especially in patients with persistent hypophosphatemia, and may help explain the association of FCM with osteomalacia and fractures that has been described in several case reports. Disclosures Wolf: Akebia: Consultancy, Honoraria; Amag: Consultancy, Honoraria; Ardelyx: Consultancy, Honoraria; AstraZeneca: Consultancy, Honoraria; Pharmacosmos: Consultancy, Honoraria; Bayer: Consultancy. Schaefer:Vifor Pharma: Honoraria; Pharmacosmos A/S: Honoraria, Research Funding. Zoller:Pharmacosmos A/S: Consultancy, Honoraria, Research Funding; Vifor Pharma: Consultancy, Honoraria.

Safety Profile of Iron Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3739-3739 ◽  
Author(s):  
Melvin H. Seid ◽  
Antoinette Mangione ◽  
Thomas G. Valaoras ◽  
Lowell B. Anthony ◽  
Charles F. Barish
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Study Drug ◽  
Test Dose ◽  
Serum Phosphate ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Drug Event ◽  
High Dose ◽  
Iv Iron

Abstract Currently available IV iron agents pose substantial safety and practical challenges to effective management of iron deficiency anemia. Iron dextran administration requires a test dose and carries the risk of anaphylaxis. Non-dextran-containing IV iron agents (iron sucrose and ferric gluconate) do not require a test dose nor have this safety issue, but pose some practical challenges. These agents are FDA approved only for chronic kidney disease indications and require repeated administration of small doses (125 mg of iron as ferric gluconate over 10 minutes, 200 mg of iron as iron sucrose over 2–5 minutes, or 300–400 mg of iron as iron sucrose over 1.5 to 2.5 h). Accordingly, in a multicenter, randomized, blinded, placebo-controlled, crossover trial we assessed the safety of iron carboxymaltose, a new, investigational non-dextran IV iron complex that allows for rapid administration of high doses of iron. Five-hundred and eighty four (584) iron deficiency anemia patients received either a blinded dose of IV iron carboxymaltose (15 mg/kg up to a maximum of 1000 mg in NS) or placebo over 15 minutes on Day 0. On Day 7, patients were crossed over to receive either placebo or iron carboxymaltose utilizing the same dosing as Day 0. We recorded all adverse events and classified as an adverse drug event (ADE) any that was considered by the investigator as being possibly or probably related to study drug. The mean dose of iron carboxymaltose administered was 962 (+ 88) mg. No CTC Grade 4 or 5 or serious ADE were reported and no subject discontinued from study drug due to an ADE. No clinically important differences in vital signs or physical exams were noted between subjects treated with iron carboxymaltose and placebo. During the post dose 24-h and 7-d treatment period, ADEs reported by >1% of patients in either treatment were higher in patients after receiving iron carboxymaltose than in patients after receiving placebo. The 24-h period events included nausea (2.1% iron carboxymaltose vs. 1.1% placebo), headache (2.0% vs. 1.3%), and dizziness (1.3% vs. 0.2%). The 7-d period events included nausea (2.5% iron carboxymaltose vs. 1.1% placebo), ALT increased (1.3% vs. 0.2%), AST increased (1.3% vs. 0%), headache (2.9% vs. 1.4%), dizziness (1.6% vs.0.2%) and rash (1.1% vs. 0.2%). The majority of the ADEs were classified by the investigator as mild to moderate. No ADE consistent with a hypersensitivity reaction was reported. One patient experienced a transient, asymptomatic, CTC Grade 1 decrease in BP (from 132/85 to 95/68 mmHg) which resolved spontaneously. CTC Grade 3 ADEs were reported in 4 patients after receiving iron carboxymaltose (headache and asymptomatic decrease in serum phosphate) and 5 patients (rash, creatinine increase and asymptomatic decrease in serum phosphate) after receiving placebo. We conclude that rapid administration of high dose iron carboxymaltose (15 mg/kg for maximum of a 1,000 mg over 15 minutes) is well tolerated and associated with minimal risk of ADE in a large cohort of patients with iron deficiency anemia.

scholarly journals A Study Examining the Efficacy of Ferric Carboxymaltose in a Large Pediatric Cohort

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 17-18
Author(s):  
Chandni Dargan ◽  
David Simon ◽  
Nathan Fleishman ◽  
Alka Goyal ◽  
Mukta Sharma
Keyword(s):  
Pediatric Population ◽  
Demographic Data ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Iron Dextran ◽  
Pediatric Hospital ◽  
Inclusion Criteria ◽  
Short Bowel ◽  
Time Period ◽  
Iv Iron

Background: Iron deficiency anemia (IDA) is common in the pediatric population with high risk factors such as nutritional deficiency, inflammatory bowel disease (IBD) and other bowel inflammatory disorders, menorrhagia, blood loss, poor absorption and anemia of chronic disease. Intravenous (IV) iron supplementation has become a more desirable mode of treatment in patients with moderate to severe anemia and in patients who are either unresponsive to or have undesirable side-effects secondary to oral iron. Iron sucrose and Iron dextran have been traditionally used in pediatrics as they both are FDA approved for use in this population. Ferric carboxymaltose (FCM) has only been FDA approved for use in adults however is currently used in pediatrics as well. One of the major advantages of Ferric carboxymaltose is the ease of dosing and efficacy. Though FCM was approved for adults in 2013 and there have been no safety concerns, it is not yet FDA approved for pediatric patients despite a few pediatric studies demonstrating its safety and efficacy (Laass, et al., 2014; Powers et al., 2017; Tan et al., 2017, Carman et al., 2019). The purpose of this study is to examine the utilization of different IV iron formulations in a large pediatric hospital as well as evaluate the safety and efficacy of ferric carboxymaltose in comparison to other IV iron formulations. At this time, we present data regarding the use of different forms of IV iron. Methods: This is a retrospective chart review study of all patients who met inclusion criteria in a large pediatric hospital who received Iron dextran, Iron sucrose, and/or FCM between the dates of 8/1/2018 through 9/30/2019. Anonymized data from eligible patients was entered into a secure electronic database. Once our population of interest was isolated, based on the proposed criteria, we reviewed charts individually and collected data including demographics and details about each IV iron administration. Demographic data encompassed race and gender. We also recorded the patients' underlying diagnosis (or diagnoses) contributing to iron deficiency anemia. In addition to compiling demographic data, we also wanted to analyze the trend of IV iron usage in our institution. This was done by tallying the number of each type of IV iron infusion monthly for the allotted time period. Results: A total of 120 patients met inclusion criteria and were included in this study with details regarding diagnosis in Figure 1. Fifty-six (46.7%) patients were male and 64 (53.3%) were female. We also analyzed the underlying diagnoses leading to IDA of patients who received IV iron infusions. Most patients had an underlying IBD diagnosis (Crohn's Disease 49.2%, Ulcerative colitis 15.8%, and Indeterminate colitis 5.8% of all included patients). Additional diagnoses included 18 patients (15%) with nutritional IDA and 8 patients (6.7%) with heavy menses. Examples of "other" diagnoses are blood loss secondary to immune thrombocytopenia, short bowel secondary to complex gastroschisis, gastrointestinal bleed secondary to Helicobacter pylori, short bowel secondary to bowel resection due to graft versus host disease after hematopoietic stem cell transplant, TMPRSS6 mutation, protein losing enteropathy, short bowel secondary to midgut volvulus and intestinal atresia, among other diagnoses. We also analyzed the overall usage of IV iron in our institution during this same time period. The number of IV iron infusions has steadily increased since August 2018. The average number of IV iron infusions was 18 per month in 2018 and 22.67 per month in 2019. As shown in figure 3, the utilization of iron dextran has decreased over time. The graph also displays that the usage of FCM at our institution continues to increase as time progresses. Conclusion: Analysis of demographic data reveals that an underlying gastrointestinal diagnosis is the most common reason for receiving IV iron likely due to decreased absorption of enteral iron. Our data has also shown that the overall usage of IV iron is increasing in the pediatric population as well as specifically FCM. This study is the first retrospective pediatric review comparing the utilization of different IV iron formulations including FCM. Preliminary data demonstrates an increase in hemoglobin after treatment with FCM, however further analysis of the data is ongoing. Figure 1 Disclosures No relevant conflicts of interest to declare.

scholarly journals Management of postpartum iron deficiency anemia: review of literature

2018 ◽  
Vol 8 (1) ◽  
pp. 338
Author(s):  
Mohamed Saber ◽  
Mohamed Khalaf ◽  
Ahmed M. Abbas ◽  
Sayed A. Abdullah
Keyword(s):  
Iron Deficiency ◽  
Blood Transfusion ◽  
Iron Deficiency Anemia ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Allogenic Blood Transfusion ◽  
Iron Dextran ◽  
Peripheral Tissues ◽  
Iv Iron

Anemia is a condition in which either the number of circulating red blood cells or their hemoglobin concentration is decreased. As a result, there is decreased transport of oxygen from the lungs to peripheral tissues. The standard approach to treatment of postpartum iron deficiency anemia is oral iron supplementation, with blood transfusion reserved for more server or symptomatic cases. There are a number of hazards of allogenic blood transfusion including transfusion of the wrong blood, infection, anaphylaxis and lung injury, any of which will be devastating for a young mother. These hazards, together with the national shortage of blood products, mean that transfusion should be viewed as a last resort in otherwise young and healthy women. Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhoea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication. Two types of intravenous (IV) preparations available are IV iron sucrose and IV ferric carboxymaltose. IV iron sucrose is safe, effective and economical. Reported incidence of adverse reactions with IV iron sucrose is less as compared to older iron preparations (Iron dextran, iron sorbitol), but it requires multiple doses and prolonged infusion time. Intramuscular iron sucrose complex is particularly contraindicated because of poor absorption. It was also stated that when iron dextran is given intravenously up to 30% of patients suffer from adverse effects which include arthritis, fever, urticaria and anaphylaxis.

VP151 Endovenous Iron Deficiency Anemia Treatment In Inflammatory Bowel Disease: Hospital-based Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 219-220
Author(s):  
Jovana Stojanovic ◽  
Flavia Kheiraoui ◽  
Enrica Maria Proli ◽  
Franco Scaldaferri ◽  
Massimo Volpe ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Technology Assessment ◽  
Bowel Disease ◽  
Health Technology ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Efficacy And Safety ◽  
Iv Iron ◽  
Inflammatory Bowel

INTRODUCTION:Iron Deficiency Anemia (IDA), a common cause of anemia in the world, is a frequently neglected disease that represents the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD) (1). The release of new intravenous (IV) iron compounds represents a great opportunity for both physicians and patients, but the higher costs might hold back their optimal diffusion. A Health Technology Assessment (HTA) approach was used to provide insights on the sustainability of the IV iron formulations in a hospital setting, with a special focus on ferric carboxymaltose.METHODS:Epidemiology of IBD, as well as IDA associated with these conditions, was assessed with a systematic appraisal of the published literature. Data on efficacy and safety of IV iron formulations currently used in Italy were retrieved from the available medical electronic databases. A hospital based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed.RESULTS:The reported prevalence of anemia in patients with IBD varies markedly from 10 to 73 percent for Crohn's Disease and from 9 to 67 percent for Ulcerative Colitis. Although there are no studies on direct comparison of different IV iron preparations, the literature indicates good efficacy and safety profiles of these formulations. However, ferric carboxymaltose seemed to provide a better and faster correction of hemoglobin and serum ferritin levels in iron-deficient patients (2,3). Our analyses indicated that ferric carboxymaltose, in spite of a greater price, would have positive benefits for the hospital, in terms of reduced costs related to individual patient management, and for the patients themselves, by reducing the number of infusions and accesses to health facilities.CONCLUSIONS:This hospital-based HTA reports an overall positive organizational, economic and ethical evaluation for the sustainable introduction of ferric carboxymaltose in the Italian outpatient setting.

scholarly journals Retrospective Case Reports of Anemic Pregnant Women Receiving Intravenous Ferric Carboxymaltose: Experience from a Tertiary Hospital in Spain

2016 ◽  
Vol 2016 ◽  
pp. 1-5 ◽  
Author(s):  
Rafael Aporta Rodriguez ◽  
Mariola García Montero ◽  
Jose Pablo Lorente Aporta ◽  
Carolina Gallego Luque ◽  
Alfonso Chacón Mayor ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Case Reports ◽  
First Trimester ◽  
Tertiary Hospital ◽  
Adverse Outcomes ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Retrospective Case ◽  
Apgar Scores

Iron deficiency and iron deficiency anemia during pregnancy call for safe treatment options that raise maternal hemoglobin levels and counterbalance iron demand and blood volume expansion while minimizing risks for the growing fetus. This retrospective study describes experience with intravenous ferric carboxymaltose given to pregnant women in a tertiary hospital in Spain. In a 5-year period, 95 pregnant women who had pretreatment hemoglobin <10 g/dL and at least one time of ferric carboxymaltose administration during pregnancy were included. Main outcome measures were week of pregnancy at iron administration, Hb levels before and after treatment, neonatal 5-minute Apgar scores, and birth weight. The majority received one dose of ferric carboxymaltose (1000 mg iron) during advanced pregnancy (median 31 weeks; interquartile range [IQR]: 27; 37 weeks) with minor to no adverse outcomes. Overall, median Hb increased from 8.5 g/dL (8.1; 8.9 g/dL) before treatment to 11.0 g/dL (9.9; 11.7 g/dL) after treatment. Normal Apgar scores were observed in all 97 infants (median birth weights 3560 g, 3270, and 3798 g). Four women received ferric carboxymaltose in the first trimester and twenty-eight during the second trimester without adverse outcomes for mother or child. These cases add to the evidence that ferric carboxymaltose administration during pregnancy is effective and safe.

scholarly journals REGAIN STUDY: Retrospective Study to Assess the Effectiveness, Tolerability, and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnant Women

Anemia ◽  
2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Saleema Wani ◽  
Mariyam Noushad ◽  
Shabana Ashiq
Keyword(s):  
Retrospective Study ◽  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Blood Hemoglobin ◽  
Iv Iron ◽  
In Pregnancy

Iron deficiency anemia (IDA) during pregnancy arises because of preexisting inadequate stores or complex physiological changes and can lead to serious maternal and fetal complications. Oral iron, either as iron sulfate or fumarate, with or without folic acid, is the most commonly used treatment for IDA in pregnancy. Intravenous (IV) iron has a role in the treatment of IDA in pregnancy, particularly in women who present late, display severe anemia (Hb ≤ 9 g/dL), or risk factors, and are intolerant/noncompliant of oral iron. Previously, administration of IV iron was minimal, owing to potentially serious anaphylactic reactions. Recently, new IV iron products have been developed, offering better compliance, tolerability, efficacy, and a good safety profile. Our study aimed to assess the effectiveness, safety, and tolerability of IV ferric carboxymaltose (FCM) in the treatment of IDA in pregnant women in the UAE. Data from 1001 pregnant women who received at least one administration of FCM (500, 1000, or 1500 mg) during their second or third trimester of pregnancy (2 years backward from study initiation) were collected retrospectively from electronic medical records at Corniche Hospital, Abu Dhabi, UAE. Results showed that 41.4% of the women were able to achieve an increase of ≥2 g/dL in blood hemoglobin overall. A change of ≥2 g/dL was achieved by 27.5% of women administered a dose of 500 mg, 39.2% of women administered a dose of 1000 mg, and 63.9% of women administered a dose of 1500 mg of IV FCM. This indicates a directly proportional relationship between increasing IV FCM dose and the increase of ≥2 g/dL in blood hemoglobin. A total of 7 (0.7%) women reported mild, nonserious adverse events during the study. Within the limits of this retrospective study, IV FCM therapy was safe and effective in increasing the mean hemoglobin of pregnant women with IDA.

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Children with Iron Deficiency Anemia Unresponsive to Oral Iron Therapy

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4552-4552
Author(s):  
Jacquelyn M. Powers ◽  
Mark P. Shamoun ◽  
Timothy L. McCavit ◽  
Leah Adix ◽  
George R. Buchanan
Keyword(s):  
Adverse Effects ◽  
Research Funding ◽  
Test Dose ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy ◽  
Hematologic Response ◽  
Post Infusion ◽  
Iv Iron

Abstract Background The standard first line therapy for iron deficiency anemia (IDA) is oral iron. Yet, many patients fail to respond to oral iron due to poor adherence and/or adverse effects. Intravenous (IV) iron is an effective means of treating IDA in patients with malabsorption of iron or who are non-adherent and/or experience adverse effects with oral iron. Some IV iron preparations carry an FDA-mandated black box warning and/or require a test dose or prolonged infusion. Ferric carboxymaltose (FCM, Injectafer®) is a relatively new IV iron preparation with demonstrated safety and efficacy in adults with IDA. The manufacturer recommended dosing is 15 mg/kg/dose (maximum 750 mg) x2 doses administered at least 7 days apart, and each individual infusion can be administered over 10 to 15 minutes, without the need for a test dose. Limited data exist on its use in children. Our objective was to assess the hematologic response and adverse effects of IV FCM in a diverse population of infants, children and adolescents with IDA who failed oral iron therapy. Method All children with IDA who received FCM at Children's Health from June 1, 2014 through June 10, 2015 were included. Subjects were identified via search of pharmacy records. All patients received at least one dose of FCM 15 mg/kg (maximum 750 mg) administered as a 15-minute IV infusion (without test dose or pre-medications). Patient characteristics, adverse effects and hematologic response were retrospectively collected from the electronic medical record. Results During the study frame, one hundred twenty-five infusions of FCM were administered to 87 patients (71% female) with a median age of 14 years (range 9 months to 20.8 years). The most common racial/ethnic group was Caucasian/White (Latino) at 45% followed by African American/Black and Caucasian/White (Non-Latino), each at 22%. The primary etiologies were heavy menstrual bleeding (38%), nutritional (24%), and GI bleeding and/or malabsorption (20%) with the remaining 18% representing other/mixed causes of IDA (e.g., inflammatory). The median dose administered during a single infusion was 750 mg (range 132 to 750 mg). No adverse effects were noted during or following the infusion in 77 subjects. Two patients had transient tingling, nausea and/or mild abdominal pain. Five others developed generalized pruritis and/or urticaria and received diphenhydramine and/or hydrocortisone, with prompt resolution. Two adolescents had more clinically significant reactions, 1 with nausea/vomiting post-infusion (likely psychogenic) requiring admission, and 1 with dyspnea 2 minutes into the infusion, requiring its immediate termination and administration of diphenhydramine, hydrocortisone and normal saline with prompt symptom resolution. One patient experienced asymptomatic extravasation during the second infusion which resulted in localized iron-staining of the skin. Median pre-infusion hemoglobin concentration for all patients was 9.1 g/dL (range 3.9 to 13.3 g/dL) (Table). A follow-up measurement was available for 76 patients at a median time of 6 weeks (range 1 to 30 weeks) post-initial infusion with a median hemoglobin increase of 3.3 g/dL (range -1.5 to 9.5 g/dL). Conclusion Intravenous FCM, administered in an outpatient infusion setting as one or two short IV infusions and without need for a test dose, was safe and effective in most children and adolescents with IDA refractory to oral iron therapy. Further clinical data are necessary to more fully characterize the extent of adverse effects in young patients. Prospective studies of IV FCM in children are indicated to assess clinical efficacy, including outcomes such as health related quality of life and fatigue. Table. *Hematologic Response to FCM Pre-Infusion **Post-Infusion Hemoglobin concentration (g/dL) All Etiologies, Pre (n=87), Post (n=76) Heavy menstrual bleeding, Pre (n=33), Post (n=26) Nutritional, Pre (n=21), Post (n=20) - 9.1 (3.9 to 13.3) 9.3 (4.2 to 13.3) 8.8 (4.9 to 12.2) - 12.2 (7.1 to 16) 12.7 (8.8 to 16) 12.2 (10.5 to 13.7) Mean corpuscular volume (fl), Pre (n=87), Post (n=76) 71.6 (49.5 to 97.4) 80.9 (53.3 to 102) Serum ferritin (ng/mL), Pre (n=80), Post (n=60) 5.2 (0.6 to 288.6) 115.7 (2.3 to 679.3) *Median laboratory values are reported. **Follow-up laboratory testing occurred at median time of 6 weeks (range 1 to 30 weeks) post-infusion. Disclosures Powers: Gensavis Pharmaceuticals, LLC: Research Funding. McCavit:Pfizer: Research Funding; Gensavis LLC: Research Funding; Novartis: Speakers Bureau. Adix:Gensavis Pharmaceuticals, LLC: Research Funding. Buchanan:Gensavis Pharmaceuticals, LLC: Research Funding.

scholarly journals Iron Therapy Induced Leukopenia

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 39-40
Author(s):  
Hussam A Almasri ◽  
Ashraf Tawfiq Soliman ◽  
Vincenzo Desanctis ◽  
Arwa E Alsaud ◽  
Ruoa Alhashimy ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Iron Deficiency ◽  
Tract Infection ◽  
Iron Deficiency Anemia ◽  
Side Effect ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Iv Iron ◽  
Iron Replacement

Introduction Iron deficiency anemia (IDA) is the most common cause of anemia in both developed and developing countries, particularly affecting females in the child bearing age and children. The treatment of IDA is a major health goal, it consists of treating the underlying cause and iron supplements. Iron replacement comes in form of oral or intravenous, there are certain side effects of this therapy including constipation and allergy. Leukopenia as a side effect of iron therapy is under reported in the literature as only sporadic cases were prescribed. We conducted a study to clarify this issue and to check for its clinical significance. Objective: To assess the relationship between iron therapy (intravenous) and leukopenia, neutropenia or lymphocytopenia, and its impact on patient's clinical settings. Materials and Methods We retrospectively reviewed the electronic medical records of patients attended Haematology clinic for iron deficiency anemia and treated with intravenous iron (ferric carboxymaltose or iron saccharide) over 2 years in Hamad Medical Corporation, Doha/Qatar. Adult female patients with IDA cases who received IV iron were included. anemia due to other nutrients deficienciesa nd conditions (including other medications) that may alter WBCs count were excluded.Age, Ethnicity, BMI, Complete blood count and iron studies data were collected before and after treatment with IV iron therapy. Infection occurrence at the time of IDA and leukopenia, the use of antibiotics and infection related complications were also collected. Leukopenia was defined as WBCs count to be less than 4000/microlitre, Neutropenia as ANC less than 1500/microlitre and lymphocytopenia as lymphocytes less than 1000/mocrolitre. Statistical analysis was done using mean , SD and t test. Results After iron therapy, out of 1567 case of iron deficiency anemia, 30 cases (1.914%) have leukopenia,15 cases (0.957%) have neutropenia and 12 cases (0.765%) have lymphocytopenia. All had normal readings before treatment. 2 patients (6.66%) had infection, 1 had upper respiratory tract infection and 1 urinary tract infection, the latter was treated with antibiotics, none reported infection related complications Discussion Leukocytopenia is defined as low WBCs circulating in the blood and this can be caused by low neutrophils count, low lymphocytes count, other WBCs components or combined. Some previous reported cases generated the idea of a possible connection between iron supplement therapy and leukopenia, Brito-Babapulle et al reported a case of fatal bone marrow suppression linked to ferric carboxymaltose therapy in a patient with IDA. The pathophysiology is not well understood but thought to be a toxic effect of iron on bone marrow and it can affect all cell lineages. Our findings suggest possible iron replacement side effect as there was significant drop of the WBCs count after treating IDA patients with IV iron, however this association was not common. There was no life threatening or serious infections in the affected patients, which can suggest that most of these cases are mild and transient. More studies are needed to address this issue, particularly on larger scales. Patient education also may be appreciated before treatment with IV iron. Conclusions: Leukopenia in form of neutropenia or lymphocytopenia maybe a side effect of IV iron therapy. Clinical significance is limited in view of current literature further studies needed to elaborate more in this important adverse event. Disclosures No relevant conflicts of interest to declare.

scholarly journals Clinical Criteria for Transitioning from Oral to IV Iron Replacement Therapy in Patients with Iron Deficiency Anemia

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 211-211 ◽  
Author(s):  
Maureen Okam ◽  
Todd Koch ◽  
Minh Ha Tran
Keyword(s):  
Reticulocyte Count ◽  
Pooled Analysis ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Oral Iron Therapy ◽  
Iron Treatment ◽  
Iv Iron ◽  
Iron Replacement

Abstract Introduction: Oral iron supplementation is an effective means of iron replacement. Nevertheless, there is a frequent need to transition patients with iron deficiency anemia (IDA) from oral to intravenous (IV) iron therapy for inadequate response. No definitive guidance on the optimal timing for this change in therapy exists. Serum hepcidin may be a marker in predicting response to oral iron therapy, but currently, hepcidin assays are not commercially available. We evaluated the ability of various early response characteristics to accurately predict for an overall hemoglobin (Hb) response to oral iron. Our objective was to identify an early predictor of overall Hb response in patients on oral iron treatment as a guide to the decision to switch from oral to IV iron in patients unlikely to benefit from continued oral iron. Methods: Proprietary datasets from 6 published randomized studies in which oral iron (325 mg of ferrous sulfate containing 65 mg of elemental iron, t.i.d.[4 studies], 304.3 mg capsules containing 100 mg bivalent iron b.i.d [1 study] and as prescribed by the investigator [1 study]) was used as a comparator to ferric carboxymaltose were analyzed. Five studies were pooled into one primary analysis dataset and one study was analyzed separately due to differences in study design that precluded pooling. Patients were grouped by the underlying etiology of their IDA (postpartum, heavy uterine bleeding, gastrointestinal, and others) and stratified by those who had ≥ 1 g/dL Hb change after 14 days of oral iron therapy (responders) and those who did not (non-responders). Further analyses evaluated Hb response at various time points based on initial 14 day Hb response (≥ 1 g/dL change vs < 1 g/dL). We systemically evaluated changes in hemoglobin, absolute reticulocyte count, % reticulocyte count, ferritin, and transferrin saturation at specific time points to determine their ability to predict overall Hb response. Results: A total of 738 patients who were randomized to oral iron were included in the pooled study analysis. In the separate study, a total of 253 patients, all non-responders, were included. The mean baseline values for the 6 studies were Hb 9.9 g/dL, ferritin 19.9 ng/mL, and TSAT 16.9%. The vast majority of patients (96%) were females with a mean age of 36 years. In the pooled analysis, by day 14 of oral iron treatment, 27.2% (201/738) of patients had a Hb increase of < 1 g/dL (non-responders). Of these 201 patients, less than half (46.8%, 94/201) achieved an increase in Hb ≥ 1 g/dL from baseline after 2 additional weeks of oral iron (by day 28) and only 63.2% (127/201) had an increase in Hb ≥ 1g/dL from baseline after 6 to 8 weeks of oral iron (42 to 56 days). Furthermore, only 27.4% (55/201) and 5.5% (11/201) had an increase in Hb of 2 or 3 g/dL respectively at the Day 42 or 56 measurement. In comparison, responders (those who had a Hb increase ≥ 1 g/dL by 14 days of treatment) sustained a robust Hb response with continued dosing of oral iron. After 4 weeks of oral iron (28 days), 84.9% of the responders had a ≥ 2 g/dL increase in Hb from baseline. After 6 to 8 weeks of oral iron (42 or 56 days), 92.9% of the patients had ≥ 2 g/dL Hb increase from baseline, significantly different from non-responders (p < 0.0001). Patients with etiology of postpartum anemia had the most robust Hb response to oral iron. Results observed in the sixth study were similar to the pooled analysis. Only 10.2% (17/167) of non-responders who continued oral iron after day 14 achieved a Hb ≥ 2g/dL by Day 35, whereas 38.8% (57/147) who were switched to IV ferric carboxymaltose achieved a Hb > 2/dL by Day 35 (p =0.0001). Hb response after 14 days of oral iron was a strong predictor of overall response (sensitivity = 90.1%, specificity = 79.3%, positive predictive value = 92.9%, negative predictive value= 72.7%), surpassing other parameters evaluated in this study. Conclusion: In the absence of significant continuous blood loss, Hb measurements taken 14 days after initiation of oral iron therapy can reliably predict overall response in Hb to oral iron therapy. Accordingly, day 14 Hb may be a useful tool for clinicians in determining when to switch patients from oral to IV iron. Disclosures Koch: Luitpold Pharmaceuticals: Employment.

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