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 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.

scholarly journals A COMPARATIVE STUDY OF INTRAVENOUS IRON SUCROSE VERSUS ORAL IRON THERAPY IN IRON DEFICIENCY ANEMIA DURING POSTPARTUM PERIOD

2021 ◽  
Vol 5 (12) ◽  
Author(s):  
Satish Kumar
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Serum Ferritin ◽  
Intravenous Iron ◽  
Hemoglobin Level ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Iron Group ◽  
Iv Iron

Introduction: Anemia is the commonest major contributing factor in maternal mortality and morbidity in developing countries and according to World Health Organization (WHO) criteria, it contributes to 20% of maternal deaths. Anemia in pregnancy defined as hemoglobin level <11 gm/dl (7.45 mmol/L) and hematocrit less than 33% (WHO). Aim: To compare the efficacy of oral iron ferrous sulphate therapy with intravenous iron sucrose therapy in the treatment of iron deficiency anemia during postpartum period. Material & Methods: This was a prospective randomized comparative clinical trial single center study conducted on 200 postpartum women aged >18 years (after normal delivery or LSCS) within 10 days of delivery with Hb level more or equal to 6 gm/dl but less than 10 gm/dl were included in the study. This was a one year study conducted during 1st December 2018 to 30th November 2019. Results : There was a significant increase in the hemoglobin level in both the groups i.e. in IV iron group, from 8.26 ±1.03gm/dl on day 1 to 11.62±0.94gm/dl on day 45 as compared to oral iron group, from 8.24±1.09gm/dl on day 1 to 11.07±1.14gm/dl on day 45; and serum ferritin level from 41.69±40.45ng/ml on day 1 to 77.34±41.60ng/ml on day 45 in IV iron group as compared to the oral iron group from 22.20±8.82ng/ml on day 1 to 31.72±9.72 ng/ml on day 45. So, there was a rapid increase in both hemoglobin and serum ferritin levels in IV iron group as compared to the oral iron group. Conclusion: Intravenous iron sucrose administration increases the hemoglobin level and serum ferritin more rapidly in compare to the oral intake of ferrous sulphate in women with iron deficiency anemia in postpartum women in our study. Keywords: Iron deficiency anemia, Intravenous iron sucrose, Serum ferritin, Maternal mortality.

scholarly journals Efficacy and safety of high dose accelerated intravenous iron sucrose in patients of iron deficiency anemia

2017 ◽  
Vol 5 (8) ◽  
pp. 3359
Author(s):  
Muzafar Naik ◽  
Tariq Bhat ◽  
Ummer Jalalie ◽  
Arif Bhat ◽  
Mir Waseem ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
High Dose ◽  
Oral Iron Therapy ◽  
The Mean

Background: Low dose (200 mg) extended Intravenous iron sucrose remains the most common treatment option in patients who are intolerant to oral iron therapy in patients with Iron deficiency anemia (IDA). The objective of this study was to evaluate the efficacy and safety of high dose accelerated intravenous iron sucrose (IS) in the treatment of adults with iron deficiency anemiaMethods: One hundred adult patients with iron deficiency anemia, who had intolerance or showed no effect with oral iron therapy, received daily doses of 500 mg of intravenous iron sucrose until the hemoglobin level was corrected or until receiving the total dose of intravenous iron calculated for each patient.Results: The mean and median Hb (g/dL) 6.47±1.656 and 6.6 (2) at baseline, 9.61±1.629 and 9.6 (2) at 2 weeks of treatment, 11.85±1.277 and 12 (1) at 4 weeks of treatment respectively. The mean rise of Hb was 3.13±1.41 and 5.37±1.50 after 2 and 4 weeks of treatment respectively (p<0.000). A total of 303 intravenous infusions of iron sucrose were administered and iron sucrose was generally well tolerated with twenty-six patients developing mild and one patient developing moderate adverse drug reactions. There was no serious adverse event recorded.Conclusions: Accelerated high dose intravenous iron sucrose is a safe and cost effective option minimizing frequent hospital visits in the treatment of adults with iron deficiency anemia who are intolerant or lack satisfactory response to oral iron therapy.

Economic, Transfusion, and Efficacy Outcomes with the Addition of IV Iron Sucrose to Oral Iron Therapy in Pregnancy Associated Iron Deficiency Anemia

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4737-4737
Author(s):  
Nilupa Gaspe Mudiyanselage ◽  
Tarek Elrafei ◽  
Beth Lewis ◽  
Mary King ◽  
Marianna Strakhan ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Iron Group ◽  
Iv Iron ◽  
Iron Replacement

Abstract Background: Prior studies have indicated that transfusion is unusual (2%) in pregnant women with iron deficiency anemia. Nonetheless, compliance with oral iron replacement can be an issue and physicians may wish to use IV iron therapy in markedly anemic pregnant women. Objectives: to evaluate the effectiveness of adding intravenous iron sucrose concentrate (ISC) to pregnant patients already taking oral iron in terms of effect on hemoglobin, effect on ferritin levels, rates of transfusion, and cost. Methods: We analyzed all referrals from Obstetrics to Hematology clinic and Obstetrics consultation (Internal medicine) clinic from January 2014 to June 2016. Of the 176 pregnant patients, 98 were referred for anemia, including 81 patients with Hgb < 12 g/dl and ferritin < 20 ug/L. All had previously been given oral ferrous sulfate prescriptions. Patients with hemoglobinopathy were excluded. All 81 patients were advised to continue on the oral iron, and 40 were given IV iron sucrose (ISC group). Results: The average cumulative dose of iron sucrose was 700 mg, a mean of 5.575 doses (initiated in the third trimester in 38 of 40 patients). The lowest antepartum Hgb was 8.18 g/dl in the ISC group and 9.58 in the oral only group; there was an average Hgb increase of 2.17 vs 1.76 g/dl respectively (p=.107 NS and the 0.41 g/dl difference was considered to be of no clinical consequence). 89% in the ISC group vs 30% in the oral achieved a ferritin >20 (p=0.000015). No adverse events in the IV iron group were reported. There was 1 transfusion in the oral iron group attributable to iron deficiency (2.4%) vs none in the IV iron group (p = 0.107 NS). Two patients were transfused in the antenatal period before IV iron was started and 1 transfused because of post-partum hemorrhage. The total cost of the IV iron therapy would add an average of $1,500 per patient. Thus, and additional cost of $60,000 in IV iron would be required to prevent 1 transfusion [40:1]. Conclusions: ISC corrects ferritin in more patients than oral iron replacement, but did not significantly increase Hgb levels or have a meaningful impact on the transfusion rate. The additional cost and lack of clinically improved outcomes with IV iron argue against its use and in favor of strategies to ensure compliance with oral iron. Disclosures No relevant conflicts of interest to declare.

scholarly journals Management of Severe Iron Deficiency Anemia in the Pediatric Emergency Department: A Comparison of IV Iron Vs Transfusions

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2011-2011
Author(s):  
Matthew Speckert ◽  
Lana Ramic ◽  
Nicholas Mitsakakis ◽  
Mira Liebman ◽  
Elaine W. Leung
Keyword(s):  
Emergency Department ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Pediatric Emergency ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Pediatric Emergency Department ◽  
Iv Iron ◽  
Parenteral Iron

Abstract Introduction: Severe iron deficiency anemia (IDA) is a problem that often presents to the pediatric emergency department (ED). Recently published ASH-ASPHO Choosing Wisely recommendations suggest avoidance of transfusion in hemodynamically stable, asymptomatic children with IDA 1. Little is known about the use of parenteral iron in this pediatric setting. Methods: We undertook a retrospective review of patients with severe IDA treated in the pediatric ED at the Children's Hospital of Eastern Ontario (CHEO) from September 2017 to June 2021. During this period there were an estimated 75000 patients seen annually. Patients with severe IDA were defined as those presenting with hemoglobin (Hb) less than &lt;70 g/L and low mean corpuscular volume. Results: There were 56 patients that met this criterion with presenting Hb ranging from 17-69 g/L (IQR 41- 62). Median age at presentation was 3.75 yrs (IQR 1.68- 15.5), with a bimodal peak at age 1 yr and again in the teen years (Fig 1). 42 (75%) patients were female. The most common causes of IDA were nutritional and heavy menstrual bleeding. 14 (24.6%) received packed red blood cell (PRBC) transfusion with or without parenteral iron (iron sucrose), and 11 (19.3%) were treated with parenteral iron alone. Almost all (55, 98.2%) were prescribed oral iron supplementation. The lower the presenting Hb, the more likely that transfusion or parenteral iron was used as initial therapy (Fig 2). 19 (33.9%) patients were admitted to hospital and 37 (66.1%) were discharged home from the ED. Nine recipients of parenteral iron alone had follow-up at CHEO, six had follow-up within 10 days with Hb increases of at least 20 g/L and all nine patients had follow-up by day 41 showing increases ranging from 20-97 g/L. Three recipients of parenteral iron alone had presenting Hb &lt;30 g/L and by 9 days following ED encounter all three had increased their Hb by at least 20 (20-32) g/L. Three patients were discharged from ED after IV iron, and none presented to the ED again. Six recipients of PRBCs had follow up within 10 days showing Hb increase ranging from 33-62 g/L, only five had follow-up by day 41 showing increases of 42-79 g/L. Five patients received &gt;1 transfusion, and transfused volumes ranged from 5-25 mL/kg. Minor infusion reactions occurred in 2 (17%) recipients of parenteral iron, and no patient was suspected to have anaphylaxis. Four (28.5%) patients experienced minor transfusion reactions to packed cells. One recipient of multiple PRBC transfusions had transfusion-associated cardiac overload (TACO) requiring ICU admission. Conclusions: This study demonstrates that patients with severe IDA can be safely and effectively managed in the ED setting with parenteral iron therapy alone without PRBC transfusion. The use of parenteral iron avoids the potential short and long-term complications associated with transfusion, whilst ensuring rapid restoration of iron stores without the tolerability issues associated with oral iron. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: IV iron sucrose is indicated for treatment of iron deficiency in patients 2 and older with CKD. The use of it outside of this context would be considered off label.

scholarly journals Efficacy, tolerability and safety of intravenous iron sucrose in postpartum anaemia

2019 ◽  
Vol 1 (1) ◽  
pp. 21-24
Author(s):  
Rucha Rajput ◽  
Ashish Podey ◽  
Tushar Baheti ◽  
Bangal V B ◽  
Sarita Deshpande
Keyword(s):  
Iron Deficiency ◽  
Blood Transfusion ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Prospective Longitudinal Study ◽  
Number Of Patients ◽  
Iv Iron ◽  
Prospective Longitudinal

Background: Anemia is one of major contributing factor in maternal mortality and morbidity in third world countries and according to the WHO, contributes to 40% maternal deaths. Postpartum anemia is observed in up to 27% of women.It is a common problem throughout the world. Treatment of postpartum iron deficiency anemia includes oral and parenteral iron supplmentaion as well as blood transfusion in severe cases. Methods: This was a prospective longitudinal study carried out in Department of Obstetrics & Gynaecology of PRH, Loni. Total 80 women suffering from postpartum anemia of age above 18 years with haemoglobin (HB) level below 11gm/dl and above 6gm/dl were included for the study. After history taking, clinical examination and baseline Hb level, all of them were administered intravenous iron sucrose 200 mg per dose per day till the total calculated dose was administered. The post therapy evaluation was done with the estimation of Hb on day 1, day 7, day 14 and day 21. Results: 31.25% women belonged to the age group each of 19-21 years and 22-24 years. Maximum number of patients received 3 doses of IV Iron sucrose (i.e. total 600mg) followed by 2 doses (i.e. total 400mg), 4 doses (i.e. total 800mg) and 5 doses (i.e. total 1000mg) respectively. Hb level rises extremely significantly (p<0.001) after IV Iron Sucrose administration on day 1, 7, 14 & 21 as compared to corresponding values before delivery as analyzed by Friedman Test (Nonparametric Repeated Measures ANOVA) . 16 patients (20%) experienced thrombophlebitis to IV Iron Sucrose administration. About 12 (15%) patients experienced rigor followed by sweating in 10 patients (12.5%) and fever in 8 patients (10%). About 62 patients (77.5%) from total 80 reported well tolerability to IV Iron Sucrose while remaining 18 patients (22.5%) reported poor tolerability to IV Iron Sucrose Conclusion: Intravenous iron sucrose increases the haemoglobin more rapidly in first week as compared to second and third week in women with postpartum iron deficiency anemia. Hypersensitivity reaction, chest pain, dyspnoea reported with iron dextran and iron sorbitol citric acid were not observed with iron sucrose. Intravenous iron sucrose can be used safely to fill a rift between blood transfusion and oral iron in treatment of postpartum iron deficiency anemia.

scholarly journals Comparative study of oral iron and intravenous iron sucrose for the treatment of iron deficiency anemia in pregnancy

2016 ◽  
Vol 6 (1) ◽  
pp. 172
Author(s):  
Apurva Garg ◽  
Manju Agarwal ◽  
Uma Shankar ◽  
Shrikant Shetty
Keyword(s):  
Iron Deficiency ◽  
Comparative Study ◽  
Iron Deficiency Anemia ◽  
Ferrous Sulphate ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Iron Group ◽  
Iv Iron

Background: The aim of this study was to compare the efficacy and safety of iron sucrose with oral iron in the treatment of iron deficiency anemia of pregnancy.Methods: An interventional comparative study was conducted at Jhalawar Medical College, Jhalawar involving 80 pregnant women with iron deficiency anemia from March 2016 to August 2016. Inclusion criteria were gestational age between 24-32 weeks with established iron deficiency anemia, with hemoglobin between 7-10g/dl. Target Hemoglobin was 11 g/dl. In intravenous iron sucrose group iron sucrose dose was calculated from following formula: total iron dose required (mg) = 2.4 x body weight in Kg x (target Hb – Patient’s Hb g/dl) + 500. In oral iron, group patient received ferrous-sulphate 335 mg daily BD. Hb level were reviewed at 2, 4, 6 weeks.Results: Change in Hemoglobin level from baseline significantly higher in IV iron group than oral iron group. In IV iron, group mean value of baseline Hb was 8.07±0.610 g/dl and in oral iron group was 8.48±0.741 g/dl. At the end of 6-week mean hemoglobin in IV iron sucrose was 10.66±0.743 g/dl and in oral iron group was 10.08±0.860 g/dl.Conclusions: Intravenous iron sucrose elevates more Hb than oral iron, with less adverse effects.

scholarly journals Iron-deficiency Anemia in Pregnant Women: What preventing Practitioners from using IV Iron Sucrose

2012 ◽  
Vol 3 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Hema Divakar
Keyword(s):  
Health Care ◽  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Health Care Professionals ◽  
Fetal Outcome ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Maternal Condition ◽  
Iv Iron

ABSTRACT Background Severe anemia in pregnancy results in relatively poor maternal and fetal outcome. Maternal effects are preterm labor, preeclampsia, sepsis and postpartum hemorrhage and increase need of blood transfusion. In India, the decision to recommend appropriate supplementation for IDA in pregnant women is left to the health care personnel and based on the individual maternal condition. Objective To assess the problems/limitations of health care practitioners to treat IDA with IV iron sucrose in pregnant women and to suggest ways forward for expansion of its use with confidence. Materials and methods The questionnaire included 18 questions altogether related to treatment, influencing factors for treatment, risk factors, attitutes and awareness about parenteral iron sucrose supplementation. All data were entered into an electronic database without personal identifiers to maintain confidentiality. The data was analyzed by using SPSS version 17.0. Results The survey consisted of responses from 107 health care professionals from urban and rural practitioners in India. Out of 107, 28.1% respondents said that the majority of the anemic patients were between 9.9 and 7.0 mg/dl Hb—moderate category. A total of 78 (72.90%) said that they would recheck Hb levels 4 weeks after oral ion treatment for checking the patient's response. Of the respondents, 42.52% of them said that the women were compliant and took supplementation as per prescription. All respondents agreed that there could be a mean 58% reduction of blood transfusions by using IV iron sucrose. Many respondents (74, 79.44%) expressed interest to have more information from recent research to expand the indications for use. Conclusion Dissemination of information related to IV iron sucrose to all practitioners and reduction in costs would help them to expand the use with confidence and avert many complications related to maternal and fetal health due to gestational anemia. How to cite this article Divakar H. Iron-deficiency Anemia in Pregnant Women: What preventing Practitioners from using IV Iron Sucrose. Int J Infertility Fetal Med 2012;3(1): 1-7.

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