MONOFERRO
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    MONOFERRO

    Hierro isomaltósido 1000

    Anemia

    Monoferro es un hierro intravenoso con una estructura química innovadora que permite infundir dosis altas de hierro hasta 20mg/kg de peso, sin dosis techo, de forma segura.1, 2
    Los beneficios de Monoferro son: correción completa de hierro en una única visita3, disminución del número de visites4, menor número de infusiones que pueden preservar las venas para accesos futuros4 y ahorro de recursos sanitarios.2, 3, 5

     Este medicamento está sujeto a seguimiento adicional, es prioritaria la notificación de sospechas de reacciones adversas asociadas a este medicamento.

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    CONSULTAR NOTA INFORMATIVA DE LA AEMPS (FV)

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    Información adicional

    Indicaciones

    Monoferro es un hierro intravenoso de alta dosis indicado en el tratamiento de la deficiencia de hierro cuando las preparaciones de hierro oral son ineficaces o no pueden usarse o cuando exista necesidad clínica de suministro rápido de hierro.1

    Posología

    La dosis y la pauta de administración de Monoferro deben ser establecidas individualmente para cada paciente.1

    Forma de administración

    Monoferro puede administrarse mediante una inyección intravenosa en bolo, perfusión intravenosa por goteo o directamente en la rama venosa del dializador.1

    Inyección intravenosa en bolo:
    Monoferro puede administrarse mediante una inyección intravenosa en bolo de hasta 500 mg hasta tres veces a la semana, con una velocidad de administración de hasta 250 mg de hierro/minuto.1

    Puede administrarse sin diluir o diluida en hasta un máximo de 20 ml de solución estéril de cloruro sódico al 0,9%.1

    Perfusión intravenosa por goteo:
    La dosis de hierro acumulada requerida puede administrarse con una única perfusión de Monoferro de hasta 20 mg de hierro/kg de peso corporal o como perfusiones semanales hasta que la dosis de hierro acumulada haya sido administrada.1

    Si la dosis de hierro acumulada excede los 20 mg de hierro/kg de peso corporal, la dosis debe ser dividida en dos administraciones con un intérvalo de tiempo de al menos una semana entre ellas.

    Dosis de hasta 1000 mg se deben perfundir durante más de 15 minutos y dosis superiores a 1000 mg se deben perfundir durante 30 minutos o más.1 Monoferro debe ser añadido en un máximo de 500 ml de solución estéril de cloruro sódico al 0,9%.1

    Inyección en el dializador:
    Monoferro se puede administrar durante una sesión de hemodiálisis directamente en la rama venosa del dializador según los mismos procedimientos indicados para la administración intravenosa en bolo.1

    Seguridad

    Supervisar atentamente a los pacientes en busca de signos y síntomas de reacciones de hipersensibilidad durante y después de cada administración de Monoferro. Debe observarse al paciente durante al menos 30 minutos después de cada inyección de Monoferro por si surgieran efectos adversos.1

    Monoferro únicamente se debe administrar en un entorno en el que se pueda garantizar un dispositivo completo de reanimación.1

    Presentaciones

    Monoferro 100 mg/ml 5 viales 1ml (CN: 670627.5)
    Monoferro 100 mg/ml 5 viales 5ml (CN: 670632.9)

     

    Referencias

    1 Agencia Española de Medicamentos y Productos Sanitarios. Centro de Información online de Medicamentos de la AEMPS. Ficha técnica MONOFERRO®  [sede web]. [Actualizado 2015; acceso noviembre 2015].
    2 Jahn MR et al. A comparative study of the physicochemical properties of iron isomaltósido 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm and Biopharm, 2011;78:480–91.
    3 Kalra PA et al. Iron isomaltoside 1000: a new high dose option for parenteral  iron therapy. Port J Nephro Hypert 2012;26(1):13-24. 
    4 Gozzard D. When is high-dose intravenous iron repletion needed? Assessing new treatment options. Drug Design, Development and Therapy 2011;5:51–60.
    Bhandari S. A hospital-based cost minimization study of the potential financial impact on the UK health care system of introduction of iron  isomaltoside 1000. Therapeutics and Clin Risk Mgt 2011;7:501-9.

    Intravenous iron supplementation with intra-articular administration of tranexamic acid reduces the rate of allogeneic transfusions after simultaneous bilateral total knee arthroplasty
    Intravenous iron supplement, tranexamic acid, transfusion, bilateral total knee arthroplasty.

    BACKGROUND: Peri-operative intravenous administration of iron supplementation seems a good option to reduce allogeneic blood transfusion in major orthopaedic surgery. However, its efficacy in simultaneous bilateral total knee arthroplasty has not been studied.

    MATERIAL AND METHODS: From December 2014 to May 2015, a total of 72 consecutive patients underwent simultaneous bilateral total knee arthroplasty and received peri-operative intravenous iron supplementation (iron isomaltoside 1000: 600 mg pre-operatively and 400 mg 1 week post-operatively) and intra-articular tranexamic acid (2 g in 20 mL saline at the end of surgery), and were managed with a restrictive transfusion trigger (haemoglobin <7 g/dL). Post-operatively, we observed patients closely for symptoms of anaemia and checked their haemoglobin levels on days 1, 6 and 13 after surgery.

    RESULTS: The mean baseline haemoglobin level was 13.1 g/dL. The levels remained above 7.0 g/dL on post-operative days 1, 6 and 13 (mean, 11.4 g/dL, 9.9 g/dL and 10.4 g/dL, respectively) in all but one patient who experienced melaena and required allogeneic blood transfusion.

    DISCUSSION: Intravenous iron supplementation combined with intra-articular administration of tranexamic acid seems to be an effective strategy for reducing the rate of allogeneic blood transfusion in patients undergoing simultaneous bilateral total knee arthroplasty managed with a restrictive transfusion trigger.

    Suh DW, Han SB, Park JH, Cheong K, Kyung BS.
    Blood Transfus. 2016;22:1-6. [Epub ahead of print]
    01/2016
    Intravenous iron isomaltoside 1000 (Monofer®) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo
    Anaemia, iron, coronary artery bypass surgery.

    BACKGROUND AND OBJECTIVES: This trial explores whether intravenous iron isomaltoside 1000 (Monofer®) results in a better regeneration of haemoglobin levels and prevents anaemia compared to placebo in preoperative non-anaemic patients undergoing cardiac surgery.

    STUDY DESIGN AND METHODS: The trial is a prospective, double-blind, comparative, placebo-controlled trial of 60 non-anaemic patientsundergoing cardiac surgery. The patients were randomized 1:1 to either 1000 mg intravenous iron isomaltoside 1000 administered perioperatively by infusion or placebo.

    RESULTS: Mean preoperative haemoglobin in the active treatment group was 14·3 g/dl vs. 14·0 g/dl in the placebo group. At discharge 5 days after surgery, haemoglobin levels were reduced to 10·7 and 10·5 g/dl, respectively. One month after surgery, haemoglobin concentration had increased to an average of 12·6 g/dl vs. 11·8 g/dl (p = 0·012) and significantly more patients were non-anaemic in the intravenous iron isomaltoside 1000-treated group compared to the placebo group (38·5% vs. 8·0%; p = 0·019). There were no differences in side-effects between the groups.

    CONCLUSION: A single perioperative 1000 mg dose of intravenous iron isomaltoside 1000 significantly increased the haemoglobin level and prevented anaemia 4 weeks after surgery, with a short-term safety profile similar to placebo. Future trials on potential clinical benefits of preoperative treatment with intravenous iron in non-anaemic patients are needed.

    Johansson PI, Rasmussen AS, Thomsen LL.
    Vox Sang. 2015 Oct;109(3):257-66.
    10/2015
    Anemia and iron deficiency in gastroenterology: a Scandinavian prospective, observational study of iron isomaltoside in clinical practice
    Frigstad SO, Hammarlund P, Bonderup O, Rannem T, Haaber A, Fallingborg J, et al.
    Poster P533, 12th ECCO Congress, 15-18 February 2017, Barcelona.
    01/2017
    High-dose fast infusion of parenteral iron isomaltoside is efficacious in inflammatory bowel disease patients with iron-deficiency anaemia without profound changes in phosphate or fibroblast growth factor 23
    Anaemia, FGF23, hypophosphataemia, IBD, intravenous iron, iron deficiency.

    Objective: Iron isomaltoside (Monofer®) is a high-dose intravenous iron preparation with good tolerability and efficacy in inflammatory bowel disease (IBD) patients with iron deficiency anaemia (IDA). This trial evaluates the safety and efficacy, including effect on intact fibroblast growth factor 23 (iFGF23) of a high single dose and cumulative doses of iron isomaltoside in IBD patients with IDA.

    Materials and methods: The trial was a prospective, open-label, multi-centre trial conducted in IBD patients with IDA. Based upon haemoglobin (Hb) levels at baseline and weight, the patients received 1500, 2000, 2500 or 3000 mg of iron isomaltoside infused in single doses up to 2000 mg. The outcome measurements included adverse drug reactions (ADRs) and changes in haematology and biochemistry parameters.

    Results: Twenty-one IBD patients with IDA were enrolled, receiving 1500 (seven patients), 2000 (eight patients), 2500 mg (four patients) or 3000 (two patients) mg of iron. No serious ADRs were observed. Four patients experienced nine mild to moderate ADRs (hypersensitivity, pyrexia, vomiting, constipation, abdominal pain, dyspepsia (two events) and eye allergy (two events)). In total, 15 (75%) patients had an increase in Hb of ≥2.0 g/dL during the trial, with normalisation of ferritin. No changes in iFGF23 or clinically significant hypophosphataemia were found.

    Conclusion: Rapid infusions of high-dose iron isomaltoside, administered as single doses up to 2000 mg and cumulative doses up to 3000 mg, were without safety concerns and were efficacious in increasing Hb levels in IBD patients. Iron isomaltoside did not induce profound phosphate wasting via increased iFGF23 levels.

    Dahlerup JF, Jacobsen BA, van der Woude J, Bark L, Thomsen LL, Lindgren S.
    Scand J Gastroenterol. 2016 Nov 1; 51(11): 1332–1338.
    11/2016
    A 1-year trial of repeated high-dose intravenous iron isomaltoside 1000 to maintain stable hemoglobin levels in inflammatory bowel disease
    Anemia, inflammatory bowel disease, intravenous iron, iron deficiency.

    Objective. Iron isomaltoside 1000 (Monofer) is a high-dose intravenous (IV) iron, which in a recent 8 weeks trial in inflammatory bowel disease (IBD) subjects with iron deficiency anemia (IDA) demonstrated good tolerability and efficacy. The present trial is an extension to this trial, which evaluates the need for additional high IV iron doses to maintain a stable hemoglobin (Hb) ‡12.0 g/dl.

    Material and methods. This was a prospective, open-label, 12 months trial of European IBD subjects willing to participate after completing the lead-in trial. Subjects were allowed re-dosing with 500–2000 mg single doses of iron isomaltoside 1000 infused over ~15 min at 3 months intervals depending on a predefined algorithm. Outcome measures included Hb, safety parameters and need for additional iron dosing.

    Results. A total of 39 subjects were enrolled of which  34 subjects required re-dosing with a median cumulative 1-year dose of 1.8 g (mean cumulative dose 2.2 g). The mean (SD)  Hb was 12.3 (1.5) g/dl at baseline, 12.8 (1.6) g/dl at 3 months, 12.8 (1.6) g/dl at 6 months, 12.9 (1.4) g/dl at 9 months and 12.9 (1.6) g/dl at 12 months. Seventy-four percent of subjects who had an Hb ‡12.0 g/dl at baseline were able to maintain Hb ‡12.0 g/dl till the end of the trial at 12 months. Nonserious probably related hypersensitivity reactions without significant  hypotension were reported at the beginning of the infusion in two subjects, who recovered without sequelae.

    Conclusion.  Repeated treatment of iron deficiency with iron isomaltoside 1000 could avoid episodes of IDA without major safety issues.

    Reinisch W, Altorjay I, Zsigmond F, Primas C, Vogelsang H, Novacek G.
    Scand J Gastroenterol. 2015;50(10):1226-33.
    10/2015
    A prospective observational study of effectiveness and safety of iron isomaltoside in patients with chronic renal failure and iron deficiency anemia
    Chronic kidney disease – intravenous iron – iron deficiency anemia – iron isomaltoside.

    AIMS: The aim of this study was to investigate the effectiveness, safety, and tolerability of iron isomaltoside in routine practical care of iron deficiency anemia (IDA) in patients with chronic renal failure.

    METHODS: The study included 698 patients with IDA on dialysis or with nondialysis chronic kidney disease (CKD) stages 3 - 5 designated by their physicians for treatment with iron isomaltoside. Data were recorded at baseline and after 3 and 9 months. Effectiveness data included measurement of hemoglobin (Hb), hematocrit, i-iron, transferrin saturation (TSAT), and i-ferritin. Safety data included adverse events and safety laboratory variables.

    RESULTS: Following administration of a mean cumulative dose of 2,574 mg isomaltoside over 9 months, initial average Hb increased from 11.0 g/dL to 11.6 g/dL, TSAT from 19.4% to 28.3%, and i-ferritin from 320 µg/L to 642 µg/L, demonstrating a positive effect of iron isomaltoside on iron deficiency. In addition, there was a significant reduction in the use of erythropoiesis-stimulating agents (ESAs) (regarding epoetin α, initial mean dose 40,688 IU/month, final dose 35,665 IU/month, -13.7%, p < 0.001). No drug-related adverse events were reported. Furthermore, safety parameters including i-phosphate indicated no abnormal changes.

    CONCLUSIONS: Iron isomaltoside demonstrated very good effectiveness and tolerability in patients with stage 3 - 5 CKD, including an ESA saving effect.

    Biggar P, Leistikow F, Walper A.
    Clin Nephrol. 2016;86(12):310-18.
    12/2016
    A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia
    Chronic kidney disease, iron isomaltoside 1000, iron treatment.

    BACKGROUND: Iron deficiency anaemia is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and is often treated with oral or intravenous (IV) iron therapy. This trial compared the efficacy and safety of IV iron isomaltoside 1000 (Monofer®) and oral iron in NDD-CKD patients with renal-related anaemia.

    METHODS: The trial was a Phase III open-label, comparative, multicentre, non-inferiority trial conducted in 351 iron-deficient NDD-CKD patients, randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sulphate administered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks (Group B). The patients in Group A were randomized into A1 (infusion of max. 1000 mg single doses over 15 min) and A2 (bolus injections of 500 mg over 2 min). A modified Ganzoni formula was used to calculate IV iron need. The primary end point was change in haemoglobin concentrations from baseline to Week 4.

    RESULTS: Iron isomaltoside 1000 was both non-inferior to oral iron at Week 4 (P < 0.001) and sustained a superior increase in haemoglobin from Week 3 until the end of the study at Week 8 (P = 0.009 at Week 3). The haemoglobin response was more pronounced with ironisomaltoside 1000 doses ≥1000 mg (P < 0.05). Serum-ferritin and transferrin saturation concentrations were also significantly increased with IV iron. Adverse drug reactions were observed in 10.5% in the iron isomaltoside 1000 group and 10.3% in the oral iron group. More patients treated with oral iron sulphate withdrew from the study due to adverse events (4.3 versus 0.9%, P = 0.2).

    CONCLUSIONS: Iron isomaltoside 1000 was more efficacious than oral iron for increase in haemoglobin and proved to be well tolerated at the tested dose levels in NDD-CKD patients.

    Kalra PA, Bhandari S, Saxena S, Agarwal D, Wirtz G, Kletzmayr J et al.
    Nephrol Dial Transplant. 2016;31:646-55.
    01/2016
    A randomized noninferiority trial of intravenous iron isomaltoside versus oral iron sulfate in patients with nonmyeloid malignancies and anemia receiving chemotherapy: The PROFOUND trial
    Anemia, cancer, iron isomaltoside, iron treatment.

    STUDY OBJECTIVE: A safe alternative to erythropoiesis-stimulating agents to treat anemia is warranted in patients with cancer and anemia; thus the objective of this trial was to compare the efficacy and safety of intravenous (IV) iron isomaltoside with oral iron in patients with cancer and anemia by testing the noninferiority of IV versus oral iron.

    DESIGN: Phase III, prospective, open-label, comparative, randomized, noninferiority, multicenter trial.

    SETTING: Forty-seven hospitals or private cancer clinics in Asia, the United States, and Europe.

    PATIENTS: A total of 350 patients with cancer and anemia.

    INTERVENTION: Patients were randomized in a 2:1 ratio to either intravenous iron isomaltoside or oral iron sulfate. Patients in the ironisomaltoside group were then randomized into an infusion subgroup (single intravenous infusions of a maximum dose of 1000 mg over 15 min) or a bolus injection subgroup (bolus injections of 500 mg over 2 min).

    MEASUREMENTS AND MAIN RESULTS: The primary efficacy outcome was change in hemoglobin concentration from baseline to week 4. Changes in other relevant hematology variables, effect on quality of life, and safety outcomes were also assessed. The primary efficacy outcome was tested for noninferiority, whereas the remaining outcomes were tested for superiority. Iron isomaltoside was noninferior to oral iron in change in hemoglobin concentration from baseline to week 4 (difference estimate 0.016, 95% confidence interval -0.26 to 0.29, p<0.001). A faster onset of the hemoglobin response was observed with infusion of iron isomaltoside (superiority test: p=0.03 at week 1), and a sustained effect on hemoglobin level was shown in both the iron isomaltoside and oral iron treatment groups until week 24. A significant mean decrease in fatigue score was observed from baseline to week 12 in the iron isomaltoside group (p<0.001) but not in the oral iron group (p=0.057). A higher proportion of patients treated with oral iron experienced adverse drug reactions (18.8% vs 6.6%, p<0.001) and discontinued the trial due to intolerance (8.0% vs 0.9%, p=0.001). Transient hypophosphatemia (phosphate level less than 2 mg/dl) was reported at similar low frequencies among the groups: 7.1% in the iron isomaltoside infusion subgroup versus 8.5% in the iron isomaltoside bolus injection subgroup versus 5.4% in the oral iron group.

    CONCLUSION: This trial demonstrated comparable sustained increases in hemoglobin concentration over time with both iron isomaltoside and oral iron. Iron isomaltoside was better tolerated than oral iron, and fatigue was significantly decreased with iron isomaltoside. Low rates of clinically insignificant hypophosphatemia were reported in patients receiving both treatments.

    Birgegard G, Henry D, Glaspy J, Chopra R, Thomsen LL, Auerbach M.
    Pharmacotherapy. 2016;36:402-14.
    01/2016
    A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia

    Abstract: Iron deficiency anemia (IDA) is common in many chronic diseases, and intravenous (IV) iron offers a rapid and efficient iron correction. This trial compared the efficacy and safety of iron isomaltoside and iron sucrose in patients with IDA who were intolerant of, or unresponsive to, oral iron. The trial was an open-label, comparative, multi-center trial. Five hundred and eleven patients with IDA from different causes were randomized 2:1 to iron isomaltoside or iron sucrose and followed for 5 weeks. The cumulative dose of iron isomaltoside was based on body weight and hemoglobin (Hb), administered as either a 1000 mg infusion over more than 15 minutes or 500 mg injection over 2 minutes. The cumulative dose of iron sucrose was calculated according to Ganzoni and administered as repeated 200 mg infusions over 30 minutes. The mean cumulative dose of iron isomaltoside was 1640.2 (standard deviation (SD): 357.6) mg and of iron sucrose 1127.9 (SD: 343.3) mg. The primary endpoint was the proportion of patients with a Hb increase ≥2 g/dL from baseline at any time between weeks 1-5. Both non-inferiority and superiority were confirmed for the primary endpoint, and a shorter time to Hb increase ≥2 g/dL was observed with iron isomaltoside. For all biochemical efficacy parameters, faster and/or greater improvements were found with iron isomaltoside. Both treatments were well tolerated; 0.6% experienced a serious adverse drug reaction. Iron isomaltoside was more effective than iron sucrose in achieving a rapid improvement in Hb. Furthermore, iron isomaltoside has an advantage over iron sucrose in allowing higher cumulative dosing in fewer administrations. Both treatments were well tolerated in a broad population with IDA.

    Derman R, Roman E, Modiano MR, Achebe MM, Thomsen LL, Auerbach M.
    Am J Hematol. 2017;92:286-91.
    01/2017
    Effects of administration of iron isomaltoside 1000 in patients with chronic heart failure. A pilot study

    SUMMARY: Intravenous iron preparations have shown benefit in patients with chronic heart failure (CHF) and iron deficiency. Iron isomaltoside 1000 (Monofer) is a novel intravenous iron compound with low immunological activity of the isomaltoside and low free-iron-related toxicity. The primary objective of this open-label, non-comparative, multicenter pilot study was to test the safety of iron isomaltoside 1000 in patients with CHF and anemia. In addition, its effect on markers of iron deficiency, anemia and on quality of life was assessed. Twenty patients with CHF and iron deficiency anemia attended six visits during the 8-week study period. Iron isomaltoside 1000 was infused at baseline (mean dose 868 mg, range 650–1000 mg). No treatment-related adverse reactions, no acute anaphylactic or delayed allergic reactions and no clinically significant changes in routine clinical laboratory safety tests or vital signs were observed. Markers of iron deficiency, anemia and quality of life improved from baseline with increase in mean value of 49% at 4 weeks in overall quality of life. Iron isomaltoside 1000 administered as a fast single infusion without a test dose to patients with CHF improved quality-of-life assessments and was well tolerated in this pilot safety study.

    Hildebrandt PR, Bruun N, Nielsen O, Pantev E, Shiva F, Larsvidebæk L et al.
    Transfusion Alternatives in Transfusion Medicine. 2010;11:131-7.
    11/2010
    Experience with a novel intravenous iron preparation. Monofer in pregnant women with iron deficiency anaemia

    Introduction: Monofer is a novel parenteral iron preparation with little free iron toxicity and low immunological potential. It can be given as a single total dose by intravenous infusion over a short time without the need for test dose. It has potential cost benefits along with user convenience and dosing flexibility leading to patient satisfaction.

    Aims/objectives: To determine the compliance with guidelines and to examine the efficacy and safety of monofer.

    Methods: Retrospective audit of the case notes over a period of 18 months between May 2012 to December 2013.

    Audit Standards: Local trust guideline and “UK national guidelines (British Committee for standards in Haematology 2011)”.

    Results: Total 50 patients were identified, 46 patients were included in the analyses. The standards were met in all 46 patients.
    Mean pre-infusion Haemoglobin was 76 (range 61–97) and mean pre-infusion ferritin was 7 (rang 1–25). Of the 46 patients who received monofer, none had severe reactions. 7(15%) had minor adverse reactions including chest and back discomfort and one developed severe bronchospasm within 5 min of commencement which led to the discontinuation of the infusion. Mean hospital stay was 7 h (range 3–48 h). Mean Haemoglobin post monofer infusion at 3–5 weeks interval was 85 (83–119). No delayed reactions were observed and none required blood transfusion.

    Conclusion: Monofer is safe and effective single dose preparation. It is well tolerated with a favourable safety profile. It reduces the blood transfusion rates, is cost effective and improves patient satisfaction. It can be given in the day case setting.

    Aslam N, Patni S.
    Arch Dis Child Fetal Neonatal. Ed 2014;99 Suppl 1:A148
    01/2014
    Single-dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: a randomized controlled trial
    Anaemia, intravenous iron, iron deficiency, iron isomaltoside, postpartum fatigue, postpartum haemorrhage.

    BACKGROUND AND OBJECTIVES: To evaluate the clinical efficacy of a single-dose intravenous infusion of iron isomaltoside compared with current treatment practice with oral iron measured by physical fatigue in women after postpartum haemorrhage.

    MATERIALS AND METHODS: Single-centre, open-label, randomized controlled trial. Participants received intravenous iron (n = 97) or oral iron (n = 99), and completed the Multidimensional Fatigue Inventory and Edinburgh Postnatal Depression Scale, and haematological and iron parameters were measured. Primary outcome was the aggregated change in physical fatigue score from baseline to 12 weeks postpartum.

    RESULTS: The difference in physical fatigue score was -0·97 (95% CI: -1·65; -0·28, P = 0·006) in favour of intravenous iron, but did not meet the predefined difference of 1·8. Across visits, we found statistically significant differences in fatigue and depression scores, as well as in haematological and iron parameters, all in favour of intravenous iron. There were no serious adverse reactions.

    CONCLUSION: A single dose of intravenous iron was associated with a statistically significant reduction in aggregated physical fatigue within 12 weeks after postpartum haemorrhage compared to standard medical care with oral iron below the prespecified criteria of clinical superiority. As patient-reported outcomes improved significantly and intravenous iron resulted in a fast hematopoietic response without serious adverse reactions, intravenous iron may be a useful alternative after postpartum haemorrhage if oral iron is not absorbed or tolerated.

    Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J.
    Vox Sang. 2017;112: 219-28.
    01/2017
    Single-dose intravenous iron infusion versus red blood cell transfusion for the treatment of severe postpartum anaemia: a randomized controlled pilot study
    Clinical trial; haemoglobin measurement; medicine; patient blood management; transfusion.

    BACKGROUND AND OBJECTIVES: There are no randomized trials comparing intravenous iron to RBC transfusion for the treatment of severe postpartum anaemia. The objectives of this study were to evaluate the feasibility of randomizing women with severe postpartum anaemia secondary to postpartum haemorrhage to RBC transfusion or intravenous iron, and to describe patient-reported outcomes, and haematological and iron parameters.

    MATERIALS AND METHODS: Women with a postpartum haemorrhage exceeding 1000 ml and an Hb between 5·6 and 8·1 g/dl were randomized to 1500 mg of intravenous iron (n = 7) isomaltoside or RBC transfusion (n = 6). Participants completed the Multidimensional Fatigue Inventory and Edinburgh Postnatal Depression Scale, and blood samples were drawn at inclusion, daily during the first week and at weeks 3, 8 and 12.

    RESULTS: We screened 162 women and included 13 (8%). There was no significant difference between groups in fatigue or depression scores. RBC transfusion was associated with a higher Hb on day 1, inhibition of reticulocytosis during the first week and low iron levels. Intravenous iron was associated with increased reticulocytosis during the first week, repleted iron stores and a higher Hb in weeks 3-12.

    CONCLUSION: This pilot study shows that intravenous iron could be an attractive alternative to RBC transfusion in severe postpartum anaemia, and that a larger trial is needed and feasible.

    Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J. Vox Sang.
    Vox Sang 2017;112:122-31.
    01/2017
    Intravenous iron therapy in patients with iron deficiency anemia: dosing considerations

    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 were retreated with IV iron between Days 56 and 90 was significantly () 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.

    Koch TA, Myers J, Goodnough LT.
    Anemia. 2015
    01/2015

    AEG

    Asociación Española de Gastroenterología

    SEN

    Sociedad Española de Nefrología

    SEDAR

    Sociedad Española Anestesia y Reanimación

    SEHH

    Sociedad Española de Hematología y Hemoterapia

    SEPD

    Sociedad Española de Patología Digestiva

    Guía de administración de MonoFerro

    Pautas de actuación en reacciones de hipersensibilidad de infusiones IV de hierro

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    Puntos claves en el diagnóstico y manejo de la anemia por deficiencia de hierro en EII* según las ECCO** guidelines 2015

    EII*: Enfermedad inflamatoria intestinal
    ECCO**: European Crohn’s and Colitis Organisation

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    2017

    LIX Congreso Nacional SEHH, 26-28 Octubre 2017

    SEHHSociedad Española de Hematología y Hemoterapia.

    Málaga
     

    Semana de las Enfermedades Digestivas, 9-11 Junio 2017

    SEPD. Sociedad Española de Patología Digestiva.

    Madrid
     

    XX Reunión Anual AEG, 8-10 Marzo 2017

    AEGAsociación Española de Gastroenterología.

    Madrid
     

    12th Congress of ECCO, 15-18 Febrero 2017

    ECCO. European Crohn's and Colitis Organisation.

    Barcelona
     

    2016

    IC Curso de la Escuela de Patología Digestiva, 24-25 Noviembre 2016

    Hospital de la Santa Creu i Sant Pau.

    Barcelona
     

    LVIII Congreso Nacional SEHH, 20-22 Octubre 2016 

    SEHHSociedad Española de Hematología y Hemoterapia.

    Santiago de Compostela
     

    XLVI Congreso Nacional de la SEN, 8-11 Octubre 2016

    SEN. Sociedad Española de Nefrología.

    Oviedo
     

    Semana de las Enfermedades Digestivas, 17-19 Junio 2016 

    SEPD. Sociedad Española de Patología Digestiva.

    Santiago de Compostela
     

    XIX Reunión Anual AEG, 1-4 Marzo 2016

    AEG. Asociación Española de Gastroenterología.

    Madrid

    Noticias

    19/06/2017
    En el marco del Congreso de Emergencias -SEMES- que tuvo lugar en Alicante del 7 al 9 de Junio 2017, Ferrer patrocinó un taller sobre Ferroterapia en Urgencias.
    16/05/2017
    La SEPD pone en marcha una encuesta para conocer el manejo clínico de la anemia ferropénica y el déficit de hierro en pacientes con Enfermedad Inflamatoria Intestinal.

    Última modificación: 26/07/2017

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