scholarly journals Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia

Anemia ◽  
2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Iftikhar Hussain ◽  
Jessica Bhoyroo ◽  
Angelia Butcher ◽  
Todd A. Koch ◽  
Andy He ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Iron Dextran ◽  
Open Label ◽  
Safety Population ◽  
Group A ◽  
Labile Iron

Several intravenous iron complexes are available for the treatment of iron deficiency anemia (IDA). Iron dextran (DEX) is associated with an elevated risk of potentially serious anaphylactic reactions, whereas others must be administered in several small infusions to avoid labile iron reactions. Ferric carboxymaltose (FCM) is a nondextran intravenous iron which can be administered in high single doses. A randomized, open label, and multicenter comparison of FCM to DEX in adults with IDA and baseline hemoglobin of ≤11.0 g/dL was conducted. A total of 160 patients were in the safety population (FCMn=82; DEXn=78). Adverse events, including immune system disorders (0% in FCM versus 10.3% in DEX,P=0.003) and skin disorders (7.3% in FCM versus 24.4% in DEX,P=0.004), were less frequently observed in the FCM group. A greater portion of patients in the FCM group experienced a transient, asymptomatic decrease in phosphate compared to patients in the DEX group (8.5% in FCM versus 0% in DEX,P=0.014). In the FCM arm, the change in hemoglobin from baseline to the highest observed level was 2.8 g/dL, whereas the DEX arm displayed a change of 2.4 g/dL (P=0.20). Treatment of IDA with FCM resulted in fewer hypersensitivity-related reactions than DEX.

scholarly journals Comparison of ferric carboxymaltose versus Iron Sucrose for treatment of iron deficiency anemia in pregnancy.

2021 ◽  
Vol 28 (04) ◽  
pp. 481-484
Author(s):  
Hira Jamal ◽  
Humaira Zafar ◽  
Mubashra Naz ◽  
Umber Fatima ◽  
Anees Fatima
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
P Value ◽  
Iron Treatment ◽  
Group A ◽  
Group B

Objective: To compare the mean increase in hemoglobin level with ferric carboxymaltose injection and iron sucrose injection for the management of the pregnant females presenting with iron deficiency anemia. Study Design: Randomized Controlled Trial. Settings: Department of Obstetrics and Gynecology Madina Teaching Hospital affiliated with University medical and Dental College Faisalabad. Period: July 2019 to December 2019. Material & Method: A total number of 100 patients presented in OPD satisfying the selection criteria were enrolled in the study after permission from ethical committee. On enrollment, a detailed clinical history which include previous iron treatment including and chronic medical disorders was taken. Clinical examination was done. Investigations for anemia include hemoglobin, reticulocyte count, peripheral film and red cell indices, serum ferritin level and Hb electrophoresis if indicated. The patients were randomly divided in two groups. In group A, females were given ferric carboxymaltose and in group B, females were given iron sucrose. After calculating the total iron deficit, patients in group A were given intravenous FCM. Patients in group B were given IS. Follow up of the patient was done after 3 weeks of intravenous iron treatment. The baseline Hb and values after 3 weeks of intravenous iron treatment were compared between the FCM and IS groups and increase in Hb level calculated as mean and SD. Both groups were analyzed for rise in Hb level by using independent sample t test. P value < 0.05 was taken as significant. Results: A total 100 pregnant female were found eligible for study, and were randomized into two groups of 50 each. Mean increase in hemoglobin level with ferric carboxymaltose and iron sucrose was evaluated, it shows that baseline Hb was 8.84±0.68 in Group A and 8.78 ±0.76 in Group B, P value was 0.67, after treatment Hb was 12.02±0.89 in Group A and 10.92 ±0.99 in Group B. Mean increase was 3.18 ±0.60 in Group A and 2.14±0.81 in Group B. P value was 0.001. Conclusion: Ferric carboxymaltose significantly increase Hb level and restores the iron stores as compare to iron sucreose. FCM is safe and effective intravenous treatment for iron deficiency anemia in pregnancy. FCM has the advantages of single large dose administration and fewer hospital visit. FCM is most suitable drug for the treatment of patients with IDA who required quick replenishment of iron stores.

scholarly journals Safety and Efficacy of Intravenous Ferric Carboxymaltose (750 mg) in the Treatment of Iron Deficiency Anemia: Two Randomized, Controlled Trials

Anemia ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Charles F. Barish ◽  
Todd Koch ◽  
Angelia Butcher ◽  
David Morris ◽  
David B. Bregman
Keyword(s):  
Iron Deficiency ◽  
Adverse Events ◽  
Iron Deficiency Anemia ◽  
Transferrin Saturation ◽  
Intravenous Iron ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Controlled Trials ◽  
Open Label ◽  
Serious Adverse Events

Background. Iron deficiency anemia (IDA) is a common hematological complication with potentially serious clinical consequences that may require intravenous iron therapy. Ferric carboxymaltose (FCM) is a stable, nondextran iron formulation administered intravenously in large single doses to treat IDA.Objective. Two open-label, randomized, placebo-controlled trials evaluated safety of multiple or single 750 mg FCM doses compared to standard medical care (SMC) in IDA patients. Secondary endpoints were improvements in hemoglobin and iron indices.Design and Patients. Adults with hemoglobin ≤12 g/dL, ferritin ≤100 or ≤300 ng/mL with transferrin saturation ≤30% were randomized to receive single (n=366) or weekly (n=343) FCM or SMC (n=360andn=366).Results. Significantly greater (P≤0.001) increases in hemoglobin and iron indices occurred in FCM groups versus SMC. In the multidose study, up to two infusions of FCM were needed to reach target iron levels versus 3–5 of intravenous iron comparators. FCM and SMC groups had similar incidences and types of adverse events and serious adverse events. Transient hypophosphatemia not associated with adverse events or clinical sequelae occurred in the FCM groups.Conclusion. Intravenous FCM is safe, well tolerated, and associated with improvements in hemoglobin and iron indices comparable to SMC when administered in single doses of up to 750 mg at a rate of 100 mg/min. Fewer FCM infusions were required to reach target iron levels compared to other intravenous iron preparations.

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 study for efficacy and safety of ferric carboxymaltose versus iron sucrose in iron deficiency anemia among pregnant women in tertiary care hospital

2019 ◽  
Vol 8 (6) ◽  
pp. 2280
Author(s):  
Divyani Agrawal ◽  
Deepa Lokwani Masand
Keyword(s):  
Iron Deficiency ◽  
Adverse Events ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Efficacy And Safety ◽  
Anemia During Pregnancy

Background: Anemia is one of the common manageable problem among the pregnant women worldwide, which contributes to maternal and perinatal mortality. This study aims to compare the efficacy and safety of intravenous ferric carboxymaltose with intravenous iron sucrose in treating anemia during pregnancy. Objective of this study was to compare safety and efficacy of intravenous ferric carboxymaltose with intravenous ferric sucrose in iron deficiency anemia during pregnancy.Methods: It’s an interventional prospective study conducted in Department of Obstetrics and Gynecology at NIMS, Jaipur, Rajasthan, India constituting of 100 pregnant women. Group 1- 50 pregnant women were treated with intravenous ferric carboxymaltose and Group 2: 50 pregnant women were treated with intravenous iron sucrose. Hemoglobin and serum ferritin levels were measured pre and post treatment with parenteral iron therapy. The efficacy of intravenous ferric carboxymaltose in comparison to intravenous iron sucrose was assessed. The evaluation of safety and tolerance with the parenteral therapy was also performed.Results: Anemia during pregnancy was more prevalent among the reproductive age group and in multiparous women. The mean rise in the hemoglobin level with ferric carboxymaltose was 2.92 gm/dl and with that of iron, sucrose was 1.08 gm/dl. The man rise in the serum ferritin levels with ferric carboxymaltose was 64.97ng/ml and with iron sucrose was 31.64 ng/ml. Ferric carboxymaltose was observed to be safer with no adverse events in comparison to the Iron sucrose which was related with adverse events among 03 pregnant women.Conclusions: Intravenous ferric carboxymaltose was more efficacious and safer in comparison to intravenous iron sucrose among pregnant women. Hence, ferric carboxymaltose is the drug of choice in treatment of iron deficiency anemia during pregnancy.

scholarly journals Efficacy and safety of ferric carboxymaltose in Indian pregnant women with iron deficiency anemia

2021 ◽  
Author(s):  
Vidya Bhat ◽  
Brunda Kiran ◽  
Girish Deshmukh ◽  
Ketan Kulkarni ◽  
Ajinkya Rodge
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Real Life ◽  
Hemoglobin Concentration ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Mean Corpuscular Hemoglobin ◽  
Open Label ◽  
Fatigue Score

Background: Iron deficiency anemia (IDA) is a significant problem worldwide particularly in women. The aim of the study was to evaluate the effectiveness of intravenous ferric carboxymaltose (FCM) in in Indian pregnant women with anemia.Method: This was a single centre, prospective, observational, open label, clinical study at real life scenario with 4 weeks follow up. Fifty pregnant women with IDA and visiting to the Radhakrishna multispecialty hospital, Bangalore, for antenatal care were enrolled for the study. IV FCM was given as per the standard protocol. Change in the laboratory parameters such as hemoglobin, mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), packed cell volume (PCV) level at baseline and after 4 weeks of completion of parenteral iron therapy was recorded and fatigue score was assessed. The pregnant women were monitored for the adverse events. Results: All pregnant women received a single IV infusion of FCM 1000 mg. A significant increase in the hemoglobin of 2.37±0.51 g/dl (p<0.001) was noted at 4 weeks, MCV rise of 19.89±21.94 (p<0.001) was noted at 4 weeks, MCHC rise was of 2.56±5.65 and PCV rise was of 4.45±2.67 (p<0.011) at over 4 weeks. Significant improvement in fatigue score was observed at 4 weeks after single FCM infusion. No adverse effects were observed in any pregnant woman throughout the duration of the study.Conclusions: This real-life observational study highlights IV FCM is effective in management of IDA in pregnant women and well tolerated. Trial registration number: CTRI/2021/02/030874 

scholarly journals The Treatment of Iron-Deficiency Anemia with Intravenous Iron Dextran

Blood ◽  
1964 ◽  
Vol 23 (3) ◽  
pp. 354-358 ◽  
Author(s):  
SIDNEY MARCHASIN ◽  
RALPH O. WALLERSTEIN
Keyword(s):  
Iron Deficiency ◽  
Gastrointestinal Bleeding ◽  
Muscle Mass ◽  
Iron Deficiency Anemia ◽  
Single Injection ◽  
Intravenous Iron ◽  
Deficiency Anemia ◽  
Iron Dextran ◽  
Acute Gastrointestinal Bleeding ◽  
Small Muscle

Abstract Iron-dextran, in doses up to 3000 mg., was administered intravenously by single injection to 37 patients with iron deficiency and to 8 additional patients with acute gastrointestinal bleeding. No serious untoward effects were observed. One patient developed chills and mild abdominal cramps 8 hours after injection. Most of the iron could be accounted for in the circulating blood immediately after the injection. Iron was cleared from the plasma slowly for 3 weeks after the administration. Iron-dextran appears to be a safe and well-tolerated intravenous preparation. It is especially useful in the treatment of iron-deficiency in immobilized patients and individuals with small muscle mass.

scholarly journals Study of Intravenous Ferric Carboxymaltose in Iron Deficiency Anemia in Women attending Gynecological Clinic: Safety and Efficacy

2017 ◽  
Vol 5 (2) ◽  
pp. 71-74
Author(s):  
Priyankur Roy ◽  
Vineet Mishra ◽  
Rohina Aggarwal ◽  
Khushali Gandhi ◽  
Shaheen Hokabaj
Keyword(s):  
Iron Deficiency ◽  
Adverse Effects ◽  
Iron Deficiency Anemia ◽  
Binding Capacity ◽  
Intravenous Iron ◽  
World Health ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Safety And Efficacy ◽  
Mild Anemia

ABSTRACT Introduction Several intravenous iron preparations are available for the treatment of iron deficiency anemia (IDA). Some of these require multiple small infusions to prevent labile iron reactions, while iron dextran (DEX) is associated with a risk of potentially serious anaphylactic reactions. Ferric carboxymaltose (FCM), a non-DEX intravenous iron, is an effective and a safe option, which can be administered in high single doses without serious adverse effects. Objective The objective of the study was to evaluate the efficacy and safety of FCM in the treatment of IDA in gynecological patients. Materials and methods It was an open, single-arm study including 442 women of age more than 18 years with definitive diagnosis of IDA and hemoglobin (Hb) between 4 and 11 gm% from December 2013 to November 2016. Out of these, 25 women were lost to follow-up and were excluded from the study. Intravenous FCM (500—1500 mg) was administered and the improvement in Hb levels and iron stores was assessed after 3 weeks of total dose infusion. Results Out of the 442 women, 417 women were included in the analysis. Most of the women were in the age group of 30 to 39 years. Most of the women had mild anemia as per the World Health Organization (WHO) guidelines. Mean Hb levels significantly increased over a period of 3 weeks after FCM administration. Other parameters like total iron-binding capacity (TIBC), ferritin, and iron also had a significant improvement after FCM administration. No serious life-threatening adverse events were observed after FCM administration. Conclusion Intravenous FCM is an effective and a safe treatment option for IDA and has an advantage of single administration of high doses without serious adverse effects. How to cite this article Mishra V, Roy P, Gandhi K, Hokabaj S, Aggarwal R. Study of Intravenous Ferric Carboxymaltose in Iron Deficiency Anemia in Women attending Gynecological Clinic: Safety and Efficacy. J South Asian Feder Menopause Soc 2017;5(2):71-74.

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