Carboxymaltose In Iron Deficiency Anemia Research Articles

Efficacy and safety of intravenous ferric carboxymaltose in iron deficiency anemia; Real-life data from Turkey, a single center experience

Efficacy and safety of intravenous ferric carboxymaltose in iron deficiency anemia; Real-life data from Turkey, a single center experience

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

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.

Intravenous ferric carboxymaltose for iron deficiency anemia in dialysis patients: Effect of a new protocol adopted for a hemodialysis limited assistance center.

Iron and erythropoietin deficiencies are determinants of anemia in chronic kidney disease. In hemodialysis (HD) patients, intravenous (IV) iron is associated with a greater hemoglobin (Hb) production and better erythropoietin response but may be associated to hypersensitivity reaction. After the 2013 European Medicines Agency report regarding early detection/management of iron allergic reactions, IV iron administration dramatically reduced in Italian Hemodialysis-Limited-Assistance-Centre (HD-CAL) where a physician is present only once a week. Objective of the study was providing an effective and secure IV iron administration protocol for HD-CAL patients. IV ferric carboxymaltose (FCM) administration was more effective and better tolerated than sodium ferric gluconate for iron deficiency correction and resolution of anemia in 24 patients undergoing HD in our HD-CAL. Six months of FCM IV treatment once a week increased ferritin and Hb compared to sodium ferric gluconate once a week leading to decreased erythropoietin consumption from 24 000 to 15 000 U/patient/week with an erythropoietin annual expense reduction. No blood transfusions, gastrointestinal intolerance or other adverse effects were reported. The FCM IV administration protocol for our HD-CAL patients was safe and no adverse events were reported, resulting in significantly increased ferritin, transferrin saturation, and Hb levels, reduction of erythropoietin requirements, and consequently reduction of erythropoietin expenses.

97 A Randomized Comparison of Ferumoxytol and Ferric Carboxymaltose for Iron Deficiency Anemia in Patients with CKD

97 A Randomized Comparison of Ferumoxytol and Ferric Carboxymaltose for Iron Deficiency Anemia in Patients with CKD

A systematic literature review and indirect comparison of iron isomaltoside and ferric carboxymaltose in iron deficiency anemia after failure or intolerance of oral iron treatment

ABSTRACTObjectives: The efficacy of oral iron in treating iron deficiency anemia (IDA) can be limited by poor gastrointestinal (GI) absorption and adverse GI symptoms; intravenous (IV) iron is a well-established alternative. The present study compared the efficacy of two IV iron formulations in patients with IDA: iron isomaltoside (IIM) and ferric carboxymaltose (FCM).Methods: A systematic literature review (SLR) was conducted to identify randomized controlled trials (RCTs) of IIM and FCM in patients with IDA. An adjusted indirect treatment comparison (ITC) of IIM and FCM was then conducted to evaluate differences in change from baseline hemoglobin and the proportion of patients achieving a clinically-relevant response.Results: The SLR identified no completed RCTs of IIM versus FCM, 5 RCTs of IIM (4 versus oral iron and 1 versus iron sucrose), and 14 RCTs of FCM (11 versus oral iron and 3 versus iron sucrose). In an ITC via iron sucrose, IIM resulted in a significantly larger increase from baseline hemoglobin with a mean difference of +0.249 g/dL with IIM relative to FCM, but there was no significant difference in the proportion of patients with a clinically-relevant response.Conclusions: IIM resulted in a larger increase from baseline hemoglobin than FCM in patients with IDA, but with no difference in the proportion of patients responding. Studies comparing IIM and FCM directly would be needed to confirm these findings.

Retrospective cohort study comparing the adverse reactions and efficacy of intravenous iron polymaltose with ferric carboxymaltose for iron deficiency anemia

To examine the adverse drug reactions (ADRs) and the efficacy of intravenous iron polymaltose and ferric carboxymaltose (FCM) among gynecology/obstetric patients with anemia. The present retrospective observational study examined data from anemic obstetrics and gynecology patients who received either iron polymaltose or FCM between January 1, 2011, and April 30, 2015, at The Royal Women's Hospital, Victoria, Australia. Patient demographic data, dosage, ADR documentation, and hemoglobin levels were collected from medical records and compared. The study included 221 patients; 111 and 110 received iron polymaltose and FCM, respectively. ADRs were documented for 18 (16.2%) patients in the iron polymaltose group and 2 (1.8%) in the FCM group (P<0.001), with no incidences of anaphylaxis. Both formulations achieved increased hemoglobin levels within 12weeks (P<0.001 for both). Mean hemoglobin level increases were similar in both groups among non-pregnant patients (P=0.186), but were greater in the iron polymaltose cohort among pregnant patients (P=0.005). FCM dose compliance was suboptimal, with 8 of 57 (14%) patients who required second visits for doses greater than 1000mg returning for the infusion. FCM was associated with a lower incidence of ADRs than iron polymaltose. Patients receiving FCM infusions were less likely to receive their total required iron dose. Further randomized prospective studies are required to compare clinical efficacy of iron polymaltose versus FCM.

Intravenous Ferric Carboxymaltose for Iron Deficiency Anemia

Research Article| February 01 2017 Intravenous Ferric Carboxymaltose for Iron Deficiency Anemia AAP Grand Rounds (2017) 37 (2): 22. https://doi.org/10.1542/gr.37-2-22 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn MailTo Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation Intravenous Ferric Carboxymaltose for Iron Deficiency Anemia. AAP Grand Rounds February 2017; 37 (2): 22. https://doi.org/10.1542/gr.37-2-22 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search toolbar search search input Search input auto suggest filter your search All PublicationsAll JournalsAAP Grand RoundsPediatricsHospital PediatricsPediatrics In ReviewNeoReviewsAAP NewsAll AAP Sites Search Advanced Search Topics: ferric carboxymaltose, iron, iron deficiency anemia Source: Powers JM, Shamoun M, McCavit TL, et al. Intravenous ferric carboxymaltose in children with iron deficiency anemia who respond poorly to oral iron. J Pediatr. 2016; 180: 212– 216; doi: https://doi.org/10.1016/j.jpeds.2016.09.053Google Scholar Researchers from multiple institutions in Texas conducted a retrospective study of children with iron deficiency anemia (IDA) who received intravenous (IV) ferric carboxymaltose (FCM) at Children’s Medical Center in Dallas. A query of pharmacy records was used to identify study patients who received FCM over a 1-year period. The medical records of study patients were reviewed to assess hematologic response to FCM treatment and adverse events related to therapy. For patients weighing >50 kg, 2 doses (each up to 750 mg) were given at least 7 days apart. Children weighing <50 kg received 1 to 2 doses of FCM at 15 mg/kg/dose. Data on response to treatment were assessed 4–12 weeks after FCM administration. Patients were considered to have a complete response to treatment if their hemoglobin normalized and their serum ferritin levels were ≥15 ng/mL; partial response was defined as an increase of ≥1.0 g/dL in hemoglobin above pre-infusion level. A total of 116 IV FCM infusions were administered to 72 patients with IDA (median age, 13.7 years; range, 9 months–18 years). Data on hematologic response to treatment were assessed in 52 study patients. Among these children, the median pre-infusion and post-infusion hemoglobin values were 9.1 g/dL and 12.3 g/dL, respectively; 68% had a complete response to treatment and 30% had a partial response. Sixty-five patients (84%) experienced no adverse effects. Among the 7 patients with an adverse event, pruritis and/or urticaria were most commonly reported. One study participant developed acute dyspnea during FCM infusion that was successfully treated with diphenhydramine and hydrocortisone. The researchers conclude that FCM administered to children and adolescents with IDA is safe and highly effective. Dr. Hogan has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device. IDA affects 3%–7% of children in the United States and is one of the most common nutritional disorders worldwide.1–6 Causes of IDA in toddlers include inadequate iron intake from prolonged breast-feeding or excessive cow milk ingestion.1–4 In children and adolescents, IDA is associated with restricted diets, inadequate absorption (due to proton pump inhibitors, H2 antagonists, tea, coffee, milk), heavy menstrual bleeding, chronic kidney disease, autoimmune disease, or inflammatory bowel disease.1–5 Affected toddlers may exhibit neurocognitive deficits while adolescents describe fatigue and concentration difficulties.1–5 Moderate to severe iron deficiency manifests with neurologic (restless leg syndrome, headache), cardiac, immunologic, and gastrointestinal dysfunction.5 Oral iron supplementation is available as different ferrous salts (gluconate, ascorbate, fumarate, and sulfate), all of which may be given as 3–6 mg of elemental iron/kilogram of body weight/day in divided doses over a minimum of 3 months.1–4 Ferrous sulfate is the... You do not currently have access to this content.

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

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.

FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease

FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease

FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease

Iron deficiency anemia (IDA) is common in chronic diseases and intravenous iron is an effective and recommended treatment. However, dose calculations and inconvenient administration may affect compliance and efficacy. We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen (FCM) with individually calculated iron sucrose (IS) doses in patients with inflammatory bowel disease (IBD) and IDA. This randomized, controlled, open-label, multicenter study included 485 patients with IDA (ferritin <100 μg/L, hemoglobin [Hb] 7-12 g/dL [female] or 7-13 g/dL [male]) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries. Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron, or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron. Primary end point was Hb response (Hb increase ≥ 2 g/dL); secondary end points included anemia resolution and iron status normalization by week 12. The results of 240 FCM-treated and 235 IS-treated patients were analyzed. More patients with FCM than IS achieved Hb response (150 [65.8%] vs 118 [53.6%]; 12.2% difference, P = .004) or Hb normalization (166 [72.8%] vs 136 [61.8%]; 11.0% difference, P = .015). Both treatments improved quality of life scores by week 12. Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience. Deviations from scheduled total iron dosages were more frequent in the IS group. The simpler FCM-based dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated IS dose regimen.