IV IRON DEXTRAN FOR IRON DEFICIENCY ANEMIA WHEN ORAL IRON WON’T DO

InPharma ◽  
1980 ◽  
Vol 240 (1) ◽  
pp. 10-10
Author(s):  
Adam K. Lewkowitz ◽  
Molly J. Stout ◽  
Emily Cooke ◽  
Seon C. Deoni ◽  
Viren D'Sa ◽  
...  

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points


Author(s):  
Mohamed Saber ◽  
Mohamed Khalaf ◽  
Ahmed M. Abbas ◽  
Sayed A. Abdullah

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.


2018 ◽  
Vol 36 (04) ◽  
pp. 366-376 ◽  
Author(s):  
Richard Burwick ◽  
Shravya Govindappagari

Objective To perform a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the benefits of intravenous (IV) iron in pregnancy. Study Design Systematic review was registered with PROSPERO and performed using PRISMA guidelines. PubMed, MEDLINE, Web of Science, ClinicalTrials.gov, Cochrane Library, and Google Scholar were searched. Eleven RCTs, comparing IV to oral iron for treatment of iron-deficiency anemia in pregnancy, were included. Meta-analyses were performed with Stata software (College Station, TX), utilizing random effects model and method of DerSimonian and Laird. Outcomes were assessed by pooled odds ratios (OR) or pooled weighted mean difference (WMD). Sensitivity analyses were performed for heterogeneity. Results We found that pregnant women receiving IV iron, compared with oral iron, had the following benefits: (1) Achieved target hemoglobin more often, pooled OR 2.66 (95% confidence interval [CI]: 1.71–4.15), p < 0.001; (2) Increased hemoglobin level after 4 weeks, pooled WMD 0.84 g/dL (95% CI: 0.59–1.09), p < 0.001; (3) Decreased adverse reactions, pooled OR 0.35 (95% CI: 0.18–0.67), p = 0.001. Results were unchanged following sensitivity analyses. Conclusion In this meta-analysis, IV iron is superior to oral iron for treatment of iron-deficiency anemia in pregnancy. Women receiving IV iron more often achieve desired hemoglobin targets, faster and with fewer side effects.


Author(s):  
Satish Kumar

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.


Anemia ◽  
2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Saleema Wani ◽  
Mariyam Noushad ◽  
Shabana Ashiq

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.


1959 ◽  
Vol 18 (4) ◽  
pp. 1409-1415 ◽  
Author(s):  
D. R. Zimmerman ◽  
V. C. Speer ◽  
V. W. Hays ◽  
D. V. Catron

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2449-2449
Author(s):  
Arpine Khudanyan ◽  
Sven Reid Olson ◽  
Thomas G. Deloughery ◽  
Joseph J Shatzel

Introduction: Iron deficiency anemia is the most common form of anemia and hematologic problem worldwide. Treatment options include oral or intravenous (IV) iron replacement. Although oral iron is commonly employed as first-line therapy, many studies suggest that IV iron more effective and associated with better quality of life when compared to oral iron. Yet, adverse infusion reactions are possible. Several forms of IV iron are used in clinical practice, including low molecular weight iron dextran (LMWID), ferumoxytol, ferric gluconate, iron sucrose, and ferric carboxymaltose. We sought to compare the efficacy and safety of LMWID and ferumoxytol, the two most frequently used products at our center. Methods: A retrospective cohort analysis was conducted using internal pharmacy records. Adults with an ICD-10 diagnosis of iron deficiency anemia treated with LMWID or ferumoxytol from 2018 to 2019 were identified. Records were reviewed for demographics, comorbidities, allergies, type and frequency of iron administered. Outcomes of interest were comparisons of baseline and post-treatment hemoglobin [Hgb] and ferritin levels and adverse events (AEs) following infusion. Results: In total 55 patients received one of the two included iron preparations. Of the 40 cases of iron deficiency treated with LMWID, only 4 patients (10%) received a second dose. Of the first LMWID infusions (dose of 1000 mg), all patients demonstrated an increase in Hgb from a mean of 12.21 to 13.15 within an average of 2.75 months. Mean ferritin levels went from 28.34 pre-treatment to 231.14 post-treatment, within an average of 3.26 months. 2 patients (5%) received premedication, one with diphenhydramine or promethazine, based on prior history of an AE. AEs were documented in 3 patients (7.5%) and included arm swelling, dysphagia with globus sensation, and nausea. No patients received premedication prior to ferumoxytol infusion. Those receiving ferumoxytol demonstrated an increase in hemoglobin from a mean of 10.25 to 12.17 within an average of 4.2 months. Ferritin increased from baseline 75.93 to 150.33 within 3 months. AE of diarrhea and nausea were reported in only one patient (6.67%) upon second infusion of ferumoxytol. No patient in either group experienced AEs requiring hospitalization, nor did any patient develop severe hypersensitivity reactions, hypotension, or hypophosphatemia. Discussion: In our retrospective cohort, LMWID or ferumoxytol for treatment of iron deficiency were well tolerated with minimal AEs, limited to arm swelling, dysphagia and nausea in 3 patients. Those treated with ferumoxytol experienced similarly few AEs, with only one patient developing transient diarrhea and nausea. Hesitancy to utilize IV iron has persisted due to concerns for potential side effects including anaphylaxis. Our encouraging results provide additional evidence for the efficacy and safety of LMWID and furomoxytol, and should help to assuage fears that IV iron might be poorly tolerated or ineffective. Disclosures Shatzel: Aronora, Inc.: Consultancy.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4891-4891
Author(s):  
Ajaz Bulbul ◽  
Emilio Araujo Mino ◽  
Vyas Dake ◽  
Adriana Bautista ◽  
Lisa Lentkowski ◽  
...  

Abstract Introduction Practice guidelines for Iron deficiency anemia (IDA) suggest taking ferrous iron in divided doses. Recent studies suggest that split daily dosing may increase serum hepcidin which reduces iron bioavailability. Adherence to oral iron supplementation (OIS) can also be a barrier to treatment. In practice iron dosing varies significantly with unclear evidence of benefit from a particular dosing regimen. Methods This is a retrospective study evaluating outcomes of different schedules of OIS in 146 patients with IDA (Hb <12.2 and/or ferritin of < 30 ng/mL) treated between June 2017-June 2018. Patients with multifactorial anemia were excluded. Descriptive statistics and Chi-square were used for analysis. Results The mean age was 66.8 ± 1.3; women constituted 70% of the cohort (M/F 44/102). Mean Hb was 11.59 ± 0.12; Median ferritin was 22 ng/ml (IQR 10-63). Four different schedules of OIS evaluated were every other day (QOD) 60% (88/146), daily (QD)15% (22/146), twice daily (BID) 12%(18/146) and three times a day (TID) 12% (18/146). After one month of OIS a mean increase in Hb was (0.44 mg/dl + 0.04). GI toxicity occurred in 10.2% (15/146), therapy discontinuation in 4.8% (7/146) and IV iron was required in 9.6 % (14/146) of all cases. Among patients without GI toxicity 65% (85/131) were on QOD vs other schedules (X² 11.7 p=0.008), 63% (87/139) were compliant on QOD (X² 9.05 p=0.029). Salvage IV iron was not required in 64% (84/132) of QOD patients (X² 22.7 p=<0.001). One month post therapy, patients on QOD schedule had ≥1 g/dl improvement in 38% (10/26) (X² 9.18 p= 0.027) and increase of >0.5g/dl in 68% (69/102) of cases (X² 9.63 p= 0.022). Conclusions Alternate day iron dosing may optimize iron absorption and is possibly a better tolerated regimen. Larger prospective studies need to confirm these findings Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2099-2099 ◽  
Author(s):  
David Hetzel ◽  
Audrone Urboniene ◽  
Kristine Bernard ◽  
William Strauss ◽  
Michael Cressman ◽  
...  

Abstract Abstract 2099 Background: While oral iron is the preferred first-line treatment for patients with iron deficiency anemia (IDA), there are patients who cannot take oral iron, do not tolerate it or do not adequately respond to oral iron. In the US and Canada, the only approved treatment options for these patients are the iron dextrans, which have boxed safety warnings and inconvenient dosing regimens. Therefore, many of these anemic patients do not receive IV iron, and remain inadequately treated and symptomatic. In the EU, several IV irons, including iron sucrose (IS), are approved for second line use. Few studies have evaluated the IV irons in head-to-head studies. Ferumoxytol (FER) is a new IV iron approved for the treatment of IDA in patients with chronic kidney disease (CKD) that is formulated to allow for bolus IV injection. This randomized, controlled trial was designed to investigate the efficacy and safety of FER compared to IS for the treatment of IDA in patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Methods: The study was designed to demonstrate non-inferiority and consisted of a 14 day screening period, treatment and a 5 week follow-up period. Key inclusion criteria included a Baseline hemoglobin (Hgb) less than 10 g/dL and >7 g/dL, and transferrin saturation (TSAT) < 20%. Patients were randomized 2:1 to receive either FER, administered as 2 injections of 510 mg 5±3 days apart, or IS, administered as 5 infusions or injections of 200 mg on 5 non-consecutive days over a 14 day period. Results: A total of 605 subjects were randomized to the 2 treatment arms (FER, n= 406; IS, n=199). FER demonstrated non-inferiority to IS in the proportion of subjects with a >2.0 g/dL increase in Hgb at any time from Baseline to Week 5 (the primary efficacy endpoint), compared to those treated with IS, (FER, 84%; IS 81%) with the lower bound of the 95% CI [-3.89%] above the predefined non inferiority margin [-15%]. In addition at each post-treatment time point, a higher percentage of FER-treated subjects achieved a >2.0 g/dL increase in Hgb compared to those treated with IS. FER also achieved non-inferiority to IS in the mean change in Hgb from Baseline to Week 5 with a robust 2.7g/dL increase in Hgb compared to 2.4g/dL with IS (the lower bound of the 95% CI [0.06g/dL] was above the predefined non-inferiority margin [-0.5g/dL]); this treatment difference (0.3 g/dL) was statistically significant (p=0.0124), and FER actually achieved superiority over IS. The overall rates of adverse events (AEs) and related AEs were lower in the FER group compared to IS-treated subjects. The serious adverse event (SAE) rate was higher in FER-treated subjects (FER, 4.2%; IS, 2.5%), but no pattern or safety trend was observed to suggest a specific safety signal; treatment-related SAEs were reported in 2 (0.5%) FER-treated subjects (1 anaphylactoid reaction and 1 hypertension). Protocol-defined AEs of Special Interest (signs/symptoms of hypotension or hypersensitivity associated with IV iron use) were reported at a higher rate in IS-treated subjects compared to the FER treatment group (IS, 5.0%; FER, 2.7%). Cardiovascular AE rates were comparable in the 2 treatment groups (1.0%). Overall, the safety profile of FER was comparable to that of IS and no new safety signals were identified. Conclusion: In this randomized, controlled trial, the efficacy and safety of 2 doses of FER were shown to be comparable to IS in treating IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. For this IDA patient population, which has limited treatment options in the US and Canada, FER may offer an important, new treatment option with a convenient 2 dose regimen. Disclosures: Off Label Use: Feraheme (ferumoxytol) injection. For treatment of iron deficiency anemia in non-CKD patients. Bernard:AMAG Pharmaceuticals, Inc.: Employment. Strauss:AMAG Pharmaceuticals, Inc.: Employment. Cressman:AMAG Pharmaceuticals, Inc.: Employment. Li:AMAG Pharmaceuticals, Inc.: Employment. Allen:AMAG Pharmaceuticals, Inc.: Employment.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4737-4737
Author(s):  
Nilupa Gaspe Mudiyanselage ◽  
Tarek Elrafei ◽  
Beth Lewis ◽  
Mary King ◽  
Marianna Strakhan ◽  
...  

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.


Sign in / Sign up

Export Citation Format

Share Document