scholarly journals MON-338 Severe Hypophosphatemia Induced by Intravenous Ferric Carboxymaltose Therapy for Iron Deficiency Anemia

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Matthew Tam ◽  
Ruchi Bhabhra

Abstract Background: Ferric carboxymaltose (Injectafer), a newer intravenous iron agent permits larger iron concentrations to be delivered in fewer doses compared to traditional preparations of intravenous iron. However, ferric carboxymaltose has been shown to up-regulate fibroblast growth factor 23 (FGF23) which can result in severe hypophosphatemia. We present a case illustrating this phenomenon. Clinical Case: A 48 year-old Caucasian female was admitted to the emergency department with complaints of gradual onset muscle weakness and severe exhaustion. Over the course of several months she noticed significant muscle weakness in all extremities. Her co-morbidities included morbid obesity (status-post Roux-en-y bypass surgery), asthma, and hereditary angioedema. Due to her history of gastric bypass surgery, the patient required monthly iron sucrose infusions over the previous two years. Her regimen was changed to ferric carboxymaltose (Injectafer) about five months prior to the admission, receiving 750mg treatments twice monthly. On admission, she was found to have severe hypophosphatemia of 1.5 mg/dL (2.1 – 4.7 mg/dL) with 25-OH vitamin D 21 ng/mL and PTH of 155 pg/mL. A random urinary phosphate was 72 mg/dL with a urine creatinine of 45 mg/dL, with calculated fractional excretion of phosphorus of 74%. Further diagnostic tests including EMG / nerve conduction studies, inflammatory markers, autoimmune workup, and creatine kinase were negative. She was found to have a ferritin of 2159 ng/mL (11 – 306 ng/mL) from previous baseline of 12.8 ng/mL with normal ESR and CRP. This was elucidated to be due to iron overload from IV iron infusions out of proportion to her needs. Therefore, ferrric carboxymaltose was discontinued. Her symptoms gradually improved with phosphorus and vitamin D supplementation. Two months later, when seen by Endocrinology, her ferritin was 1220 ng/mL, PTH 44 pg/mL, and phosphorus normalized to 2.6 mg/dL. Conclusion: Ferric carboxymaltose can cause profound phosphaturia and hypophosphatemia by inhibiting the cleavage of intact FGF23 to the inactive form, a mechanism similar to autosomal dominant hypophosphatemic rickets. Previous clinical trials show the incidence of hypophosphatemia to be as high as 41-70%. We conclude that baseline phosphorus and vitamin D levels should be obtained prior to therapy and monitored closely during treatment. Reference: Adkinson NF et al. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial. Am J Hematol. 2018;93(5):683.

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
S. Hardy ◽  
X. Vandemergel

Introduction. Parenteral iron formulations are frequently used to correct iron deficiency anemia (IDA) and iron deficiency (ID). Intravenous formulation efficacy on ferritin and hemoglobin level improvement is greater than that of oral formulations while they are associated with lower gastrointestinal side effects. Ferric carboxymaltose- (FCM-) related hypophosphatemia is frequent and appears without clinical significance. The aim of this study was to assess the prevalence, duration, and potential consequences of hypophosphatemia after iron injection.Patients and Methods. The medical records of all patients who underwent parenteral iron injection between 2012 and 2014 were retrospectively reviewed. Pre- and postinjection hemoglobin, ferritin, plasma phosphate, creatinine, and vitamin D levels were assessed. Patients who developed moderate (range: 0.32–0.80 mmol/L) or severe (<0.32 mmol/L) hypophosphatemia were questioned for symptoms.Results. During the study period, 234 patients received iron preparations but 104 were excluded because of missing data. Among the 130 patients included, 52 received iron sucrose (FS) and 78 FCM formulations. Among FS-treated patients, 22% developed hypophosphatemia versus 51% of FCM-treated patients, including 13% who developed profound hypophosphatemia. Hypophosphatemia severity correlated with the dose of FCM (p=0.04) but not with the initial ferritin, hemoglobin, or vitamin D level. Mean hypophosphatemia duration was 6 months. No immediate clinical consequence was found except for persistent fatigue despite anemia correction in some patients.Conclusions. Hypophosphatemia is frequent after parenteral FCM injection and may have clinical consequences, including persistent fatigue. Further studies of chronic hypophosphatemia long-term consequences, especially bone assessments, are needed.


Author(s):  
Divyani Agrawal ◽  
Deepa Lokwani Masand

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.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3186-3186
Author(s):  
Thomas A Bensinger ◽  
Ayana M Elliott ◽  
Laura Hostovich ◽  
Martin D. Weltz

Abstract Abstract 3186 Introduction: Iron deficiency anemia (IDA) continues to be a problem in the United States in the 21st Century. Differentiating IDA from anemia of chronic disease (ACD) is important in the clinical practice setting because iron supplementation has been shown to be beneficial for IDA and may deleteriously affect ACD patients. We examined consecutive patients referred for a diagnosis of anemia in a single community-based hematology-oncology practice in the suburbs of a major city over an 8 month period. IDA was found amongst these patients. The common possible causes, symptoms and usual treatment for this subset of patients are reported. Methods: Records of all adult patients referred to the practice with a diagnosis of anemia and were then confirmed to be iron deficiency anemia from March 2010 until November 2010 were reviewed. Chart review analysis was performed to identify differences in gender, causes, symptoms, treatment plans, treatment efficacy, pertinent history and physical findings including laboratory studies - CBC, ferritin, iron/TIBC, reticulocyte count, review of the peripheral blood film, and often but not always, an erythropoietin level. Results: A significant number of patients (n = 130) demonstrated iron deficiency anemia. The vast majority of these patients were female (94%). Most patients were also premenopausal. Four patients were pregnant. The most common cause of iron deficiency anemia was heavy menstrual blood loss associated with the presence of uterine fibroids (67%) followed by, gastric bypass surgery (24%). Interestingly, a subset of patients (12%) had a history of both gastric bypass and heavy menstrual blood loss. Other associated causes found to be linked to IDA were gastrointestinal lesions, such as AV malformations, gastritis, including medication induced gastritis (nonsteroidal anti-inflammatory drugs), hiatal hernia and at least one colon cancer. Subjective symptoms of IDA included tiredness, weakness, exhaustion, brittle nails and hair loss. The finding of pica was quite extensive and often not reported by the patient unless questioned in detail. Pica symptoms included the desire for ice (pagophagia), clay or starch, and also revealed some unusual urges, including eating toilet paper or paper towels, dirt from a patient's rose garden, or the urge to chew gum with the amount exceeding several packages of greater than 10 sticks each per day. One patient reported eating leaves which were stripped from a garden plant. Laboratory studies on these patient subset revealed only 3 had a ferritin level greater than 20 ng/mL (3%). The MCV was less than 80 fl in 111 of the 130 patients. Thrombocytosis (a platelet count of greater than 400,000.103 ml) was an associated finding of IDA and occurred 40 of 130 patients (30%). The platelet count returned to normal in all but one patient post treatment. Conclusion: Iron deficiency is a pervasive problem that is not adequately assessed and treated. Many of our clinic patients developed iron deficiency anemia as a result of surgical intervention, such as gastric bypass surgery. We recommend identifying IDA early to treat patients efficaciously for optimal outcomes. Close attention should be given to key clinical indicators including low MCV and variant forms of pica syndrome which is a valid symptom of iron deficiency. Our experience with administering intravenous iron preparations suggests that patients have improvements in overall well being often within a few days of the first infusion. The pica syndrome resolved in approximately two weeks post the first dose of iron in most patients, even prior to demonstrating any significant improvement in the hemoglobin and hematocrit or the MCV levels. This may imply that iron deficiency affects fundamental enzymes for metabolic processes found in the oral mucosa leading to the PICA. Intravenous iron administration was often used in our practice to bring the hemoglobin and hematocrit to more favorable levels in order to reduce symptoms of iron deficiency or to undergo surgical procedures and childbirth as needed. There was an occasional reaction to intravenous iron that included pruritis, back pain and an unusual swelling in the joints (e.g., knees). We have treated these patients with 100 mg of hydrocortisone intravenously and 25 mg of diphenhydramine intravenously. All reactions usually abated within 30 minutes. We had no fatal reactions to the use of intravenous iron preparations. Disclosures: No relevant conflicts of interest to declare.


Author(s):  
Priyankur Roy ◽  
Vineet Mishra ◽  
Rohina Aggarwal ◽  
Khushali Gandhi ◽  
Shaheen Hokabaj

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.


Author(s):  
Emine Çelik ◽  
Rukiye Saç ◽  
Nermin Dindar Badem ◽  
Yıldız Dallar Bilge ◽  
Bulent Alioglu

Objectives: Iron deficiency anemia (IDA) is most frequent in children under five years old. Many studies have shown a high prevalence of vitamin D deficiency (VDD) in similar age group. An association between IDA and VDD was reported. The objective of our study was to determine whether there is an association of VDD with IDA in Turkish children under 5 years old. Methods: Children, ages between four months-five years were included in a case–control study. Two groups were constituted: children with IDA (group I) and healthy control children without IDA (group II). Serum 25(OH) vitamin D levels lower than 20 ng/mL were considered as deficiency. Results: Mean age of group I (n=211, 24.8±17.5 months, 45% males) and group II (n=149, 26.4±17.7 months, 44% males) were comparable (p>0.05). Median vitamin D level in group I (22.5 ng/ml) was lower than group II (32.3 ng/mL) (p=0.001). The frequency of VDD was 38.5% in group I and 14.5% in group II (p<0.001). Sixteen children had subclinical rickets signs (All <36 months old); 14 of these were in group I (p=0.034). Conclusions: VDD is more frequent in small children with IDA than healthy controls. Most of the children presenting subclinical rickets signs had concurrent IDA. Physicians should note that VDD or even subclinical rickets may associate to IDA in children younger than 36 months old.


2021 ◽  
Vol 28 (04) ◽  
pp. 481-484
Author(s):  
Hira Jamal ◽  
Humaira Zafar ◽  
Mubashra Naz ◽  
Umber Fatima ◽  
Anees Fatima

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.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 484-484
Author(s):  
Lawrence T. Goodnough ◽  
David Morris ◽  
Todd Koch ◽  
Andy He ◽  
David Bregman

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.


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