Effectiveness and safety of ferric carboxymaltose treatment in children and adolescents with inflammatory bowel disease and other gastrointestinal diseases
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TLDR
Overall FCM was well tolerated in this pediatric population and appeared to be effective in correcting iron deficiency anemia.Abstract:
The treatment of iron deficiency anemia in children with inflammatory bowel disease is a particular challenge and often insufficient. Absorption of orally given iron may be impaired by intestinal inflammation and treatment with oral iron may aggravate intestinal inflammation. This retrospective study is the first to describe the use of intravenous ferric carboxymaltose (FCM) in the pediatric setting. All subjects who had received at least one dose of FCM intravenously in the observation period were included in this analysis with data collected for up to 3 months post last FCM dose. In total, 72 children between 0 and 18 years with underlying gastrointestinal disorders had been treated for concomitant iron deficiency anemia. The majority of patients had Crohn’s disease (40.3%) or ulcerative colitis (30.5%). The total number of FCM administrations was 147, the mean number per patient was 2.0 and the mean cumulative dose 821 mg iron (median single dose: 500 mg; max. 1000 mg). Post administration of FCM, correction of iron deficiency anemia was observed with improved mean hemoglobin levels from 9.5 g/dL at baseline to 11.9 g/dL within 5–12 weeks. Decreases in white cell count, platelets and C-reactive protein were observed post FCM, potentially suggesting reduced inflammation with iron repletion. Three subjects reported mild adverse drug reactions related to FCM; two of these were considered to be potentially related to long duration of administration and to high volume of saline solution for dilution. As such, the method of administration was amended to have a maximum infusion time of 60 minutes and dilution with less than or equal to 100 mL saline solution. Overall FCM was well tolerated in this pediatric population and appeared to be effective in correcting iron deficiency anemia. We cannot exclude that the correction of iron deficiency anaemia is in some part due to the treatment of the underlying disease and not related to the iron supplementation only.read more
Citations
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Journal ArticleDOI
Nutrition in Pediatric Inflammatory Bowel Disease: A Position Paper on Behalf of the Porto Inflammatory Bowel Disease Group of the European Society of Pediatric Gastroenterology, Hepatology and Nutrition.
Erasmo Miele,Raanan Shamir,Marina Aloi,Amit Assa,Christian Braegger,Jiri Bronsky,Lissy de Ridder,Johanna C. Escher,Iva Hojsak,Sanja Kolaček,Sibylle Koletzko,Arie Levine,Paolo Lionetti,Massimo Martinelli,Frank M. Ruemmele,Richard K. Russell,Rotem Sigall Boneh,Johan Van Limbergen,Gigi Veereman,Annamaria Staiano +19 more
TL;DR: This position paper represents a useful guide to help the clinicians in the management of nutrition issues in children with IBD.
Journal ArticleDOI
Ferric Carboxymaltose: A Review of Its Use in Iron Deficiency
TL;DR: Intravenous ferric carboxymaltose was generally well tolerated, with a low risk of hypersensitivity reactions, and was generally better tolerated than oral ferrous sulfate, mainly reflecting a lower incidence of gastrointestinal adverse effects.
Journal ArticleDOI
ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Iron and trace minerals.
Magnus Domellöf,Peter Szitanyi,Venetia Simchowitz,Axel Franz,Francis B. Mimouni,Espghan,Espen,Espr +7 more
TL;DR: The guidelines on pediatric parenteral nutrition were published by the ESPGHAN/ESPEN/ESPR/CSPEN guidelines as mentioned in this paper, which focused on iron and trace minerals.
Journal ArticleDOI
Intravenous Ferric Carboxymaltose in Children with Iron Deficiency Anemia Who Respond Poorly to Oral Iron
Jacquelyn M. Powers,Jacquelyn M. Powers,Mark Shamoun,Timothy L. McCavit,Leah Adix,George R. Buchanan +5 more
TL;DR: FCM administered as a short IV infusion without a test dose proved to be safe and highly effective in a small yet diverse population of infants, children, and adolescents with IDA refractory to oral iron therapy.
Journal ArticleDOI
Advances in Pediatric Intravenous Iron Therapy.
TL;DR: It is suggested that front line use of IV iron should be strongly considered in diseases associated with IDA in children and the availability of newer IV iron products allows for replacement of the total iron deficit at a single setting.
References
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Journal ArticleDOI
Long-Lasting Neural and Behavioral Effects of Iron Deficiency in Infancy
Betsy Lozoff,John L. Beard,James R. Connor,Barbara T. Felt,Michael K. Georgieff,Timothy J Schallert +5 more
TL;DR: Evidence of long-term effects of iron deficiency in infancy and follow-up studies from preschool age to adolescence report poorer cognitive, motor, and social-emotional function, as well as persisting neurophysiologic differences.
Journal ArticleDOI
Guidelines on the diagnosis and management of iron deficiency and anemia in inflammatory bowel diseases
Christoph Gasche,Arnold Berstad,Ragnar Befrits,Christoph Beglinger,Axel Dignass,Kari Erichsen,Fernando Gomollón,Henrik Hjortswang,Ioannis E. Koutroubakis,Stefanie Kulnigg,Bas Oldenburg,David S. Rampton,Oliver Schroeder,Juergen Stein,Simon Travis,Gert Van Assche +15 more
TL;DR: Recommendations are made regarding diagnostic measures to screen for iron- and other anemia-related deficiencies regarding the triggers for medical intervention, treatment goals, and appropriate therapies.
Journal ArticleDOI
A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial.
Stefanie Kulnigg,S. Stoinov,Vladimir Simanenkov,Larisa V Dudar,Waldemar Karnafel,Luis Chaires Garcia,Alicia M Sambuelli,Geert R. D'Haens,Christoph Gasche +8 more
TL;DR: FeCarb is effective and safe in IBD-associated anemia, and provides a fast Hb increase and a sufficient refill of iron stores, and is noninferior to FeSulf in terms of Hb change over 12 wk.
Journal ArticleDOI
FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease.
Rayko Evstatiev,Philippe Marteau,Tariq Iqbal,Igor Khalif,Jürgen Stein,Bernd Bokemeyer,Ivan V. Chopey,Florian S. Gutzwiller,Lise Riopel,Christoph Gasche +9 more
TL;DR: 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.
Journal ArticleDOI
Intravenous Iron Sucrose versus Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease—A Randomized, Controlled, Open-Label, Multicenter Study
Oliver Schröder,Oliver Mickisch,Ursula Seidler,Andreas de Weerth,Axel Dignass,Hans Herfarth,Max Reinshagen,Stefan Schreiber,Ulrich Junge,Marc Schrott,Jürgen Stein +10 more
TL;DR: Results suggest a better gastrointestinal tolerability for iron sucrose in short- and long-term efficacy as well as in tolerability over iron sulfate in the management of IDA in IBD.