5PSQ-017 Safety of intravenous ferric carboxymaltose in treatment of iron deficiency in children under 2 years with intestinal failure

Abstract

BackgroundChildren with intestinal failure (IF) are dependent on parenteral nutrition (PN) for normal growth and development. In our practice, individualised PN contain iron-free paediatric trace element mixtures due to the risk of compatibility problems. Children with IF are thus at risk of developing iron deficiency (ID). Furthermore, oral/enteral iron supplementation (IS) is avoided in children with IF because of the reduced absorptive capacity and risk of side-effects. Intravenous (IV) IS with ferric carboxymaltose (FCM) is an approved therapeutic indication for adolescents (>14 years) and adults (see SmPC Ferinject Vifor), however there are no published reports on the effectiveness and safety of IV FCM treatment of ID in children<2 years of age.PurposeThe purpose of this study was to evaluate the safety of IV IS with FCM for patients with IF under the age of 2 years.Material and methodsPart I study: The Swedish Medical Products Agency (MPA) was contacted to collect adverse drug reaction report data for the period 2007 to 2016.Part II study: A retrospective study of the records of 14 children with IF and ID who had been treated with IV FCM before 2 years of age at our tertiary centre for paediatric IF, were performed. Ganzoni’s equation was used for calculating the FCM dose, serum levels of haemoglobin, mean corpuscular volume and ferritin were measured before and 1 to 3 months after FCM treatment.ResultsPart I: During the 10 years the MPA only received five Adverse Drug Reaction Reports (ADR): Hot flush, hypertension, hypotension and venous thrombosis limb were reported. The ADR data is likely based on treatments for patients>14 years.Part II: All children received one or two doses of FCM administered as intravenous infusion. All children responded to FCM treatment with complete or partial normalisation of biochemical markers for ID. No major or minor adverse events were reported.ConclusionThe treatment of iron deficiency with intravenous ferric carboxymaltose in children<2 years of age with intestinal failure was found effective in the retrospective study of the limited number of patients from our clinic. We did not find any evidence of adverse events.References and/or AcknowledgementsFerinject SmPC.No conflict of interest

Intravenous ferric carboxymaltose for the management of iron deficiency and iron deficiency anaemia in children and adolescents: a review

“…Findings on the efficacy of FCM in children and/or adolescents were reported in 27 of the 33 publications (Table 1 ) [ 21 – 28 , 30 – 33 , 36 – 44 , 46 – 48 , 50 , 51 , 53 ]. In 26 of the 27 publications that included efficacy results, FCM treatment (in most cases a single dose) was associated with improvement in anaemia and/or different iron status parameters, including improvements in levels of haemoglobin (22 publications), ferritin (12 publications), mean corpuscular volume (10 publications), iron (six publications) and transferrin saturation (five publications) (Table 1 ).…”

“…In addition, a study of 51 children reported improvements in haemoglobin, iron and TSAT following FCM treatment [ 39 ]. The use of FCM has also been reviewed retrospectively in children < 2 years old with intestinal failure and ID [ 21 ]. All 14 children who received one or two doses of FCM responded with complete or partial normalisation of markers for ID.…”

“…Safety findings in relation to the use of FCM in children and/or adolescents were reported in 25 of the 33 publications (Table 1 ) [ 21 – 23 , 25 – 28 , 30 – 41 , 43 , 45 , 46 , 50 , 51 , 53 ]. The reported incidence and types of adverse events (AEs) varied between the publications (Table 1 ) but were in line with those described in the prescribing information [ 17 , 18 ].…”

Analysis of transition from intravenous iron sucrose to ferric carboxymaltose infusions in pediatric patients with intestinal failure

“…Studies in adult and pediatric patients with inflammatory bowel disease demonstrate significant, longer lasting improvements in anemia at a few months after administration of FCM when compared with other iron formulations. There are no longer term studies in pediatric patients, as all studies followed patients for around 12 weeks 10,12,16–19 . There is a single study in pediatric patients with IF <2 years of age, but no longitudinal follow‐up 19 .…”

“…There are no longer term studies in pediatric patients, as all studies followed patients for around 12 weeks. 10,12,[16][17][18][19] There is a single study in pediatric patients with IF <2 years of age, but no longitudinal follow-up. 19 Currently, there are no longitudinal studies guiding the potential use of FCM in pediatric patients with IF who typically require longterm iron repletion.…”