Effectiveness and safety of ferric carboxymaltose to treat iron deficiency anemia in cancer patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23153-e23153
Author(s):  
Burak Yasin Aktas ◽  
Vildan Eda Kayku ◽  
Alma Aslan ◽  
Neyran Kertmen ◽  
Omer Dizdar ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Cancer Patients ◽  
Iron Deficiency Anemia ◽  
Transferrin Saturation ◽  
Cytotoxic Chemotherapy ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Gastrointestinal Malignancies ◽  
Iv Iron ◽  
The Impact

e23153 Background: Most cancer patients are faced with anemia during the disease course. Iron deficiency (ID) is one of the major causes of anemia in cancer patients.Bleeding, malabsorption and organ dysfunction may cause iron deficiency in cancer patients. Anemia may result in a decrease in the patient's performance and delayed chemotherapy. Administration of intravenous (IV) iron is a therapeutic option in cancer patients with iron-deficiency related anemia. In this study we analyzed effectiveness and tolerability of ferric carboxymaltose in cancer patients with iron deficiency anemia Methods: This is a retrospective analysis of 603 cancer patients who were treated with ferric carboxymaltose for anemia and iron-deficiency between October 2014 and April 2017 in a tertiary cancer clinic. Demographic data, cancer diagnoses, pre- and post-treatment hemoglobin levels, pre-treatment ferritin, serum iron, and transferrin saturation (TSA) levels were recorded. Results: The median age of the population was 55 (22-90) years, and 52% were male. Of 603 patients, 47.9% (n = 289) had gastrointestinal malignancies and 17% (n = 103) had breast cancer. A total of 331 patients (55%) received cytotoxic chemotherapy and 272 patients (45%) were not on anti-cancer treatment. Median dose of the ferric carboxymaltose is 1000 mg (500-2000). The median baseline hemoglobin, ferritin and TSA were 10.7 (7-13) g/dl, 28 (2.9-2200) ng/ml and 9.3 (1-19) %, respectively. The median hemoglobin level at the 12th week of treatment was 12.7 g/dl. The median increase in hemoglobin was 2.9 (-0.10-6.9) g/dl in patients whom received cytotoxic chemotherapy. Only 2 patients had allergic reaction during IV ferric carboxymaltose administration and treatment was discontinued. Conclusions: Intravenous-iron improved hemoglobin levels both in actively treated and not-actively treated cancer patients. The effect has been shown in the first 3 months after injection. This approach is safe and tolerable. However, the impact of tumor progression on IV iron replacement is unclear, further studies are required.

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.

Iron Deficiency Anemia in Cancer Patients

2012 ◽  
Vol 08 (02) ◽  
pp. 74
Author(s):  
Mark Janis ◽  
Keyword(s):  
Iron Deficiency ◽  
Cancer Patients ◽  
Iron Deficiency Anemia ◽  
Iron Transport ◽  
The Body ◽  
Deficiency Anemia ◽  
Functional Iron Deficiency ◽  
Iron Stores ◽  
Iv Iron ◽  
Absolute Iron Deficiency

Anemia is highly prevalent, affecting approximately 40 % of cancer patients, and results in a significant decrease in health-related quality of life while also being associated with shorter cancer survival times. A recent survey of 15,000 cancer patients in Europe found that 39 % were anemic at the time of enrolment. In addition, anemia is a recognized complication of myelosuppressive chemotherapy, and it has been estimated that, in the US, around 1.3 million cancer patients who are not anemic at the time of diagnosis will develop anemia during the course of their disease. The etiology of anemia in cancer patients is variable and often multifactorial, and may be the result of an absolute or a functional iron deficiency. Cancer produces an enhanced inflammatory state within the body—causing hepcidin levels to increase and erythropoietin production to decrease—and results in a reduction in erythropoiesis due to impaired iron transport. This type of anemia is known as functional iron deficiency, where the body has adequate iron stores but there are problems with mobilization and transport of the iron. Absolute iron deficiency is when both iron stores and iron transport are low. The National Comprehensive Cancer Network (NCCN) treatment guidelines for cancer-related anemia recommend intravenous (IV) iron products alone for iron repletion in cancer patients with absolute iron deficiency, and erythropoiesis-stimulating agents (ESAs) in combination with IV iron in cancer patients (currently undergoing palliative chemotherapy) with functional iron deficiency. Although IV iron has been demonstrated to enhance the hematopoietic response to ESA therapy, the use of supplemental iron has not yet been optimized in oncology. Here we discuss the significance of iron deficiency anemia in cancer patients and the need to implement tools to properly diagnose this condition, and we provide an overview of the management strategies and recommendations for patients with iron deficiency anemia as outlined in the NCCN guidelines.

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.

Abstract 13109: Oral and Intravenous Iron Therapy for Iron Deficiency Anemia After Cardiac Surgery

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Venturini Elio ◽  
Venturini Veronica ◽  
Francesco Giallauria
Keyword(s):  
Cardiac Surgery ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Aortic Surgery ◽  
Transferrin Saturation ◽  
Small Sample ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Low Grade ◽  
Significant Difference

Introduction: cardiac surgery is associated with a high risk to develop iron deficiency anemia (IDA) with impact on the Cardiac Rehabilitation (CR) program. Sucrosomial Iron (SI) is a new oral iron with good gastrointestinal compliance and bioavailability Hypothesis: to compare SI with Ferric Carboxymaltose (FCM) i.v. the gold standard treatment for IDA. Methods: 67 consecutive patients admitted to a CR unit after cardiac surgery (27 CABG, 29 valves/aortic surgery, 11 CABG+valves) were alternately treated with SI or FCM. Blood parameters were assessed at the admission (8-10 days after surgery) (T1), at discharge (18-22 days after surgery) (T2) and 10 days from discharge (T3). The study design provides for a single dose of 1000 mg of FCM at T1 or a dose of 120 mg of SI per day for the first 8-10 days after T1; then SI was scaled to 30 mg/die up to T3. Two groups were comparable in terms of age (SI vs FCM: 67.3 ± 12.8 vs 70.2 ± 12.2) and ejection fraction (SI vs FCM: 52.7% ± 7.8 vs 53.9% ± 5.4). Because the small sample size, non-normal distributed longitudinal variables were logarithmically transformed, to guarantee the maximum possible power to the analysis. Results: data are shown in the following table. At T1, two treatment groups showed no statistically significant difference. Hemoglobin significantly increased in both groups, without significant difference at T3. Transferrin saturation and Sideremia significantly increase in both groups, although the correction is faster with FCM. Ferritin, elevated to baseline for inflammatory condition after surgery, is reduced in the SI group, while it increases significantly in FCM group. Conclusions: SI is able to correct post-surgical IDA in times and ways comparable to i.v. FCM. The hyperferritinemia observed with FCM at T2 may be due to a low-grade pro-inflammatory effect correlated to the high level of iron deposition in macrophages. SI is able to recover IDA and to achieve normal Ferritin values, avoiding the risk of hyperferritinemia.

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.

Hepcidin Levels Predict Non-Responsiveness to Oral Iron Therapy in Patients with Iron Deficiency Anemia

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 484-484
Author(s):  
Lawrence T. Goodnough ◽  
David Morris ◽  
Todd Koch ◽  
Andy He ◽  
David Bregman
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Transferrin Saturation ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Predictive Values ◽  
Oral Iron Therapy

Abstract Abstract 484 Background Treatment options for individuals diagnosed with iron deficiency anemia (IDA) include oral or intravenous iron. Oral iron may not increase patient hemoglobin levels adequately, due to poor compliance and/or suboptimal gastrointestinal absorption due to inflammation-mediated induction of hepcidin, which regulates iron homeostasis. This study evaluated whether hepcidin levels can be used to identify patients with IDA who are unresponsive to oral iron therapy. Methods Hepcidin levels were assessed in a subset of subjects enrolled in a randomized trial comparing oral iron (ferrous sulfate) to intravenous iron (Injectafer®[ferric carboxymaltose, FCM]) in subjects with IDA (Hemoglobin [Hb] ≤ 11 g/dL; and ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL when transferrin saturation (TSAT) was ≤ 30%) (Szczech et al Amer Soc Nephrol 2011; 22:405A). Subjects who met the inclusion criteria underwent a 14-day (run-in) course of ferrous sulfate 325 mg, three times per day. Subjects with an increase in Hb ≥ 1 g/dL were considered to be “responders” and not randomized. “Non-responders” were randomized to ferric carboxymaltose (2 injections of 750 mg given on Day 0 [day of randomization] and Day 7) or oral iron for 14 more days. Hb levels and markers of iron status were assessed at screening (day-15), day-1 and day 35. Hepcidin levels were analyzed at screening (Day -15) in an initial Cohort (I) of 44 patients, 22 responders and 22 non-responders. A hepcidin value of >20 ng/mL was identified for further analysis for predictive values for non-responsiveness to 14 day oral iron run-in in 240 patients (Cohort II). Hepcidin levels were also analyzed at Day -1 and Day 35 in a Cohort (III) of patients who were then randomized to FCM vs. oral iron therapy. Results Hepcidin screening levels in Cohort I were significantly higher in the non-responders vs. responders (33.2 vs. 8.7 ng/mL, p < 0.004). Twenty one of 22 non-responders had hepcidin values > 20 ng/mL. For Cohort II, mean hepcidin levels were again significantly higher in the non-responders vs. responders (38.4 vs. 11.3 ng/mL, p = 0.0002). Utilizing a hepcidin criterion of > 20 ng/mL, we found a sensitivity of 41.3% (26 of 150), specificity of 84.4% (76 of 90), and a positive predictive value (PPV) of 81.6% (62 of 76) for non-responsiveness to oral iron (Figure: The Receiver Operator Characteristic curves present plots of sensitivity vs. (1-specificity) for hepcidin, ferritin, and TSAT at the various cutoff levels indicated near the respective curves in the same color as the respective curves). While ferritin < 30ng/mL or TSAT <15% had greater sensitivity (77.3% and 64.7%, respectively), their PPVs (59.2% and 55%) were inferior to PPVs for hepcidin. Patients subsequently randomized to FCM vs. oral iron responded with Hgb increases of ≥1 g/dL for 65.3% vs. 20.8% (p <0.0001)and mean Hgb increases of 1.7 ± 1.3 vs. 0.6 ± 0.9 g/dL (p = 0.0025), respectively. Conclusion Our analysis provides evidence that non-responsiveness to oral iron in patients with iron deficiency anemia can be predicted from patients' baseline hepcidin levels, which have superior positive predictive values compared to transferrin saturation or ferritin levels. Furthermore, non-response to oral iron therapy does not rule out iron deficiency, since two thirds of these non-responders to oral iron responded to IV iron. Disclosures: Goodnough: Luitpold: Consultancy. Off Label Use: ferric carboxymaltose for treatment of iron deficiency anemia. Morris:Luitpold: Consultancy. Koch:Luitpold: Employment. He:Luitpold: Employment. Bregman:Luitpold: Employment.

scholarly journals Efficacy and Cost Effectiveness of Intravenous Ferric Carboxymaltose Versus Iron Sucrose in Adult Patients with Iron Deficiency Anemia

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 19-20
Author(s):  
Ahmed Basha ◽  
Mohamed Izham ◽  
Anas Hamad ◽  
Prem Chandra ◽  
Nabil E Omar ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Transferrin Saturation ◽  
Adult Patients ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Surrogate Outcomes ◽  
Before And After ◽  
The Cost

Abstract: Objectives: Iron deficiency anemia (IDA) is a major health issues and common type of nutritional deficiency worldwide. For IDA treatment, IV iron is a useful therapy. Many intravenous (IV) iron preparations are used for treatment of iron-deficiency anemia (IDA). The purpose of this study is to evaluate the efficacy of ferric carboxymaltose (FCM) in comparison to iron sucrose (IS) in treatment of IDA adult patients; considering cost-effectiveness (CE) for IDA patients from Qatar healthcare system perspective. We evaluated both treatments considering their response outcomes at 12 months period as well their respective acquisition costs. Methods: This was a cross sectional study with retrospective data performed on 764 IDA adult patients who were treated either with FCM or IS for IDA linking clinical efficacy (defined as improvement in hemoglobin (HB), ferritin and transferrin saturation levels) utility, and CE evaluation, including Incremental Cost-Effectiveness Ratio (ICER) over a 12-months period. The response to treatment was the primary outcomes. As the clinical laboratory data were collected before and after the first injection of the medications. The cost i.e. resources consumed were also the main outcome in our study. The cost effectiveness of FCM and IS was the secondary outcome. Direct healthcare costs were derived from the national healthcare payer system. Both descriptive and differential statistics were applied for data analysis. Alpha = 0.05. Results: Patients in the IS group used significantly higher number of injections, ampoules of medication, NS 0.9% bags and visits to the IV suite compared to FCM group. There were significant changes of laboratory tests between the FCM and IS groups. Further analysis in the change of effectiveness, indicated that the changes of hemoglobin and MCH levels in the IS group were significantly higher than the FCM group. The overall cost of IS therapy was significantly slightly higher than FCM. The medication cost for FCM was approximately 6.5 times higher than IS but cheaper in terms of bed cost and nursing cost. CE ratio illustrated that FCM and IS were significantly different in terms of HB, ferritin and MCH levels. Further, ICER indicated that further justifications and decisions need to be made for FCM when using HB, iron, transferrin saturation, MCH and MCV levels as the surrogate outcomes. Conclusions: The higher cost of FCM versus IS can be offset by savings in healthcare personnel time and bed space. ICER indicated that further justifications and decisions need to be made for FCM when using HB, iron, transferrin saturation, MCH and MCV levels as the surrogate outcomes. Limitations and strengths: Limited data is available with respect to comparison of safety and adverse effects of FCM and IS. The data is reliable as it was collected and documented before and after the treatment. Patients were monitored 30 min after the infusion to ensure keen observation and maximum safety. Disclosures No relevant conflicts of interest to declare.

scholarly journals Intravenous Iron Therapy in Patients with Iron Deficiency Anemia: Dosing Considerations

Anemia ◽  
2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Todd A. Koch ◽  
Jennifer Myers ◽  
Lawrence Tim Goodnough
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Cumulative Dose ◽  
Clinical Studies ◽  
Intravenous Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Iv Iron ◽  
Iron Deficit

Objective.To provide clinicians with evidence-based guidance for iron therapy dosing in patients with iron deficiency anemia (IDA), we conducted a study examining the benefits of a higher cumulative dose of intravenous (IV) iron than what is typically administered.Methods.We first individually analyzed 5 clinical studies, averaging the total iron deficit across all patients utilizing a modified Ganzoni formula; we then similarly analyzed 2 larger clinical studies. For the second of the larger studies (Study 7), we also compared the efficacy and retreatment requirements of a cumulative dose of 1500 mg ferric carboxymaltose (FCM) to 1000 mg iron sucrose (IS).Results.The average iron deficit was calculated to be 1531 mg for patients in Studies 1–5 and 1392 mg for patients in Studies 6-7. The percentage of patients who wereretreatedwith IV iron between Days 56 and 90 was significantly (p<0.001) lower (5.6%) in the 1500 mg group, compared to the 1000 mg group (11.1%).Conclusions.Our data suggests that a total cumulative dose of 1000 mg of IV iron may be insufficient for iron repletion in a majority of patients with IDA and a dose of 1500 mg is closer to the actual iron deficit in these patients.

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