What is the optimal administration of IV iron sucrose to pediatric and adolescent patients to minimize the risk of adverse reactions? Is there a recommended maximum dose per infusion, a preferred concentration, and/or a preferred rate of administration? Are any pre-medications recommended and how long should patients be monitored after an infusion?

Comment by InpharmD Researcher

Clinical studies in pediatric and adolescent patients have not identified an optimal dose to minimize the incidence of adverse reactions. Studies have supported intravenous (IV) iron sucrose dosing within a range of 2-7 mg/kg/dose (maximum of ~100-300 mg) diluted in 0.9% sodium chloride to a concentration ≥1 mg/mL and administered either as an infusion over 30-90 minutes or as a slow IV push over 5 minutes. Routine premedication is generally not recommended or supported by clinical trial data in pediatric patients. Adverse reactions to IV iron sucrose are rare; most reported reactions have been minor (flushing, nausea, hypotension), with hypersensitivity reactions highly uncommon (rates reported ~0.3%-0.4%). Pediatric literature has reported monitoring patients continuously during IV infusions and for at least 30 minutes after the end of infusions.

Background

According to 2026 American Academy of Pediatrics (AAP) and American Society of Pediatric Hematology-Oncology clinical guidance on iron deficiency and iron deficiency anemia (IDA) in infants, children, and adolescents, intravenous (IV) iron sucrose is FDA-approved for pediatric patients over 2 years of age, carries no black box warning, and requires no test dose, distinguishing it from low-molecular-weight iron dextran. The guidance specifies a maximum FDA-approved single infusion dose of 100 mg for initial treatment and 300 mg for maintenance, administered undiluted over 5 minutes or diluted over 30 to 90 minutes. IV iron is recommended for children with refractory or persistent IDA after at least 3 months of oral therapy, particularly those with elevated hepcidin from chronic inflammatory conditions or intestinal malabsorption, and referral to a pediatric specialty center experienced in parenteral iron is advised. The guidance underscores that appropriate monitoring with staff prepared for rare hypersensitivity reactions is essential, that extravasation can cause long-lasting skin staining, and recommends follow-up 4 to 6 weeks post-infusion to confirm sustained hematologic response, with additional infusions guided by repeat complete blood cell and iron studies rather than fixed continuation. [1]

Relevant Prescribing Information

Pediatric Patients (2 Years of Age and Older) with HDD-CKD for Iron Maintenance Treatment [2]
For iron maintenance treatment: Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 0.9% NaCl at a concentration of 1 to 2 mg/mL and administered over 5 to 60 minutes. Do not dilute to concentrations below 1 mg/mL. Venofer treatment may be repeated if necessary.

The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established.

Pediatric Patients (2 Years of Age and Older) with NDD-CKD or PDD-CKD who are on Erythropoietin Therapy for Iron Maintenance Treatment
For iron maintenance treatment: Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 0.9% NaCl at a concentration of 1 to 2 mg/mL and administered over 5 to 60 minutes. Do not dilute to concentrations below 1 mg/mL. Venofer treatment may be repeated if necessary.

The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.

Warnings and Precautions [2]
Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Literature Review

A search of the published medical literature revealed 7 studies investigating the researchable question:

Level of evidence

C - Multiple studies with limitations or conflicting results Read more→

Please see Tables 1-7 for your response.

Intravenous Iron Sucrose for Children with Iron Deficiency Failing to Respond to Oral Iron Therapy
Design	Retrospective, observational study N= 38
Objective	To evaluate the safety and efficacy of intravenous iron sucrose in children with iron deficiency who fail to respond to oral iron therapy
Study Groups	Study cohort (N= 38)
Inclusion Criteria	Children ≤18 years of age who received IV iron sucrose for non-renal indications
Exclusion Criteria	Patients with chronic renal disease and those with insufficient medical records
Methods	Pharmacy records were reviewed for pediatric patients receiving IV iron sucrose doses, diluted in maximum 250 mL normal saline and administered over 15 minutes to 3.5 hours based on patient age and weight. When administering IV iron sucrose, the total cumulative dose was divided and given every 3-7 days until the total dose was administered. The recommended maximum single dose was 300 mg, or 7 mg iron/kg, to prevent adverse events. Data on primary indication, underlying diagnoses, prior iron therapy, laboratory values, and adverse reactions were collected.
Duration	Data collection: January 1, 2004 to June 30, 2009
Outcome Measures	Primary: Hemoglobin concentration change Secondary: Adverse reactions
Baseline Characteristics		Study cohort (N= 38)
	Age, years (range)	5 (3 months to 18 years)
	IV sucrose dose, mg (range)	100 (25 to 500)
	Reason for IV sucrose, n Iron deficiency refractory to oral iron therapy Iron malabsorption or dependence on parenteral nutrition Chronic gastrointestinal blood loss Miscellaneous indications	13 13 7 5
	Of the 510 test doses given within the cohort, only 7 were preceded by iron test doses.
Results	Endpoint	Study cohort (N= 38)
	Hemoglobin rise after oral iron in varying populations, g/dl (range) Non-adherent/intolerant to oral iron Iron malabsorption Chronic blood loss Miscellaneous	0.05 (-1.0 to 1.0) 0.4 (-0.4 to 3.3) 0.65 (-1.4 to 5.7) 1.1 (0 to 2.2)
	Hemoglobin rise after IV iron sucrose in varying populations, g/dl (range) Non-adherent/intolerant to oral iron Iron malabsorption Chronic blood loss Miscellaneous	3.1 (0.8 to 7.6) 1.9 (-2.7 to 5.8) 1.9 (0.2 to 6.6) 2.1 (0.6 to 2.7)
	IV iron sucrose was effective at raising the hemoglobin concentration in all 4 patient groups and was superior to oral iron in the children refractory to oral iron or with malabsorption (p< 0.001 and p= 0.04, respectively).
Adverse Events	6 adverse reactions in 6 patients: headache (1), abdominal pain (2), transient mild hypotension (1), vasovagal syncope (1), serious reaction (1) with body aches, facial swelling, thready pulse, and hypotension; doses associated with mild adverse reactions ranged 100-300 mg. Patient who reported serious reaction received a dose greater than recommended maximum of 300 mg.
Study Author Conclusions	In conclusion, parenteral iron is a safe and effective means to treat and/or or prevent iron deficiency in children who 1) do not respond to oral iron due to intolerance or poor adherence, 2) cannot absorb oral iron due to congenital or acquired gastrointestinal disorders, and 3) who have ongoing blood loss making preventive oral supplementation ineffective. Prospective studies of IV iron preparations in children using standardized dosage guidelines are indicated to confirm and extend these results.
Critique	Limitations of the study include its retrospective design, lack of standardized dosing, limited side effect data collection, and absence of iron test doses prior to therapy initiation. Additionally, neonates were not the focus of the study; thus, applicability of the findings to a neonate population is uncertain.

Table 1 References:
[3] Crary SE, Hall K, Buchanan GR. Intravenous iron sucrose for children with iron deficiency failing to respond to oral iron therapy [published correction appears in Pediatr Blood Cancer. 2012 Apr;58(4):655]. Pediatr Blood Cancer. 2011;56(4):615-619. doi:10.1002/pbc.22930

Response of Iron Deficiency Anemia to Intravenous Iron Sucrose in Pediatric Inflammatory Bowel Disease
Design	Retrospective study N= 12
Objective	To evaluate the safety and efficacy of intravenous iron sucrose (IS) in iron deficient children with inflammatory bowel disease (IBD) in remission
Study Groups	All patients (N= 12)
Inclusion Criteria	Patients aged 0 to 18 years with a diagnosis of IBD and treatment with IS over a 1-year period, in remission
Exclusion Criteria	Patients with recorded symptoms of active disease
Methods	Electronic medical records were searched for patients treated with IS. IS was administered in cycles of 2 infusions, 2.5 to 3.5 mg/kg/dose (maximum 200 mg), 1 week apart. Response was assessed by changes in ferritin, hemoglobin (Hb), and mean corpuscular volume (MCV)
Duration	1-year period
Outcome Measures	Changes in ferritin, hemoglobin (Hb), and mean corpuscular volume (MCV)
Baseline Characteristics		All patients (n= 12)
	Age, years	15.4
	Female	9 (75%)
	Crohn's disease	10 (83%)
	Ulcerative colitis	2 (17%)
Results		Pre-treatment	Post-treatment	p-value
	Ferritin, ng/mL	21.4 ± 9.2	52.9 ± 10.1	0.0005
	Hemoglobin, g/dL	10.9 ± 0.4	11.3 ± 0.3	0.02
	Mean corpuscular volume, fl	76.9 ± 2	79.4 ± 2	0.006
Adverse Events	No adverse effects were recorded
Study Author Conclusions	Two IS infusions of 2.5 to 3.5 mg/kg/dose (maximum 200 mg), given 1 week apart normalized ferritin levels in most pediatric IBD patients in remission without adverse effects. Further studies are needed to determine optimal dosing schedules.
Critique	The study provides valuable insights into the use of intravenous iron sucrose in pediatric IBD patients, showing efficacy in increasing ferritin levels without adverse effects. However, the small sample size and retrospective design limit the generalizability of the findings. Additionally, the study did not address long-term outcomes or compare IS with other iron supplementation methods.

Table 2 References:
[4] Danko I. Response of Iron Deficiency Anemia to Intravenous Iron Sucrose in Pediatric Inflammatory Bowel Disease. J Pediatr Pharmacol Ther. 2016;21(2):162-168. doi:10.5863/1551-6776-21.2.162

Comparison of the Safety and Efficacy of 3 Iron Sucrose Iron Maintenance Regimens in Children, Adolescents, and Young Adults With CKD: A Randomized Controlled Trial
Design	Multicenter randomized controlled trial N= 145
Objective	To evaluate the safety and efficacy of three different dosing regimens of intravenous (IV) iron sucrose in maintaining hemoglobin levels in children, adolescents, and young adults with chronic kidney disease (CKD) receiving erythropoiesis-stimulating agent (ESA) therapy
Study Groups	0.5 mg/kg (n= 49) 1.0 mg/kg (n= 47) 2.0 mg/kg (n= 49)
Inclusion Criteria	Male or female patients aged 2 to 21 years with CKD receiving stable ESA therapy for 8 weeks or longer, with hemoglobin levels between 11.0 to 13.5 g/dL, ferritin ≤800 ng/mL, and transferrin saturation (TSAT) between 20% to 50%
Exclusion Criteria	Not specified in the provided text
Methods	Participants were stratified by dialysis category and weight, then randomized to receive 0.5, 1.0, or 2.0 mg/kg of iron sucrose. Hemodialysis patients received the medication every other week for 6 doses, while non-hemodialysis patients received it every 4 weeks for 3 doses. The study drug was administered undiluted over 5 minutes by IV push or diluted in 25 mL of 0.9% sodium chloride and administered over 5-60 minutes.
Duration	12 weeks
Outcome Measures	Primary: Composite of hemoglobin level 10.5-14.0 g/dL, TSAT 20%-50%, and stable ESA dosing Secondary: Decrease in ESA dose, hemoglobin level changes, TSAT changes
Baseline Characteristics		0.5 mg/kg (n= 49)	1.0 mg/kg (n= 47)	2.0 mg/kg (n= 49)
	Mean age (y)	13.8 ± 4.40	13.1 ± 4.62	13.1 ± 4.87
	Sex - Male	28 (57%)	25 (53%)	31 (63%)
	Race - White	29 (60%)	24 (52%)	31 (64%)
	Weight (kg)	45.2 ± 18.41	43.5 ± 22.93	42.5 ± 20.82
	Dialysis category - Hemodialysis	31 (63%)	30 (64%)	30 (61%)
	Baseline Hb (g/dL)	12.22 ± 0.79	12.19 ± 0.85	12.03 ± 0.78
	Baseline TSAT (%)	33.0 ± 10.1	33.2 ± 9.4	33.2 ± 10.1
Results		0.5 mg/kg (n= 46)	1.0 mg/kg (n= 45)	2.0 mg/kg (n= 40)
	Clinical success	12/46 (26%)	10/45 (22%)	12/40 (30%)
	Hb 10.5-14.0 g/dL	27/46 (59%)	21/45 (47%)	18/40 (45%)
	TSAT 20%-50%	15/46 (33%)	18/45 (40%)	20/40 (50%)
	Stable ESA dosing	46/46 (100%)	45/45 (100%)	39/40 (98%)
Adverse Events	No differences were noted between regimens in reported adverse effects, which were all minor. Common adverse events included viral respiratory tract infection, headache, vomiting, peritonitis, and increased blood pressure.
Study Author Conclusions	IV iron sucrose at a dose of 0.5 mg/kg at the intervals prescribed is noninferior to higher doses in maintaining hemoglobin levels ≥10.5 g/dL in children, adolescents, and young adults receiving ESA therapy.
Critique	The study provided valuable insights into the dosing of IV iron sucrose in pediatric CKD patients, demonstrating noninferiority of lower doses. However, the absence of a control group receiving no IV iron and the short duration of intervention and observation are limitations. Additionally, only a small proportion of patients achieved the primary clinical outcome, which may affect the generalizability of the results.

Table 3 References:
[5] Goldstein SL, Morris D, Warady BA. Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial. Am J Kidney Dis. 2013;61(4):588-597. doi:10.1053/j.ajkd.2012.10.019

Intravenous Iron Sucrose for Children With Iron Deficiency Anemia
Design	Retrospective cohort study N= 142
Objective	To describe the safety and effectiveness of IV iron sucrose for treatment of IDA in children
Study Groups	All patients (N= 142)
Inclusion Criteria	Children, adolescents, and young adults aged 22 years and below who received IV iron sucrose at the Floating Hospital for Children at Tufts Medical Center between 2004 and 2014
Exclusion Criteria	Receiving >10 doses of IV iron sucrose; diagnosis of a hemoglobinopathy; receipt of a packed red blood cell transfusion; receipt of erythropoietin; diagnosis of chronic renal insufficiency or renal failure; diagnosis of anemia of chronic disease
Methods	Pharmacy records were reviewed for children who received IV iron sucrose. Laboratory markers of anemia and iron studies were obtained preinfusion and postinfusion. IV iron sucrose was administered at 5 mg/kg with a maximum dose of 250 mg, mixed in normal saline and infused over 60 to 90 minutes. Vital signs were monitored every 15 minutes during infusion
Duration	2004 to 2014
Outcome Measures	Primary: Safety and effectiveness of IV iron sucrose Secondary: Changes in hemoglobin, mean corpuscular volume, serum iron, ferritin, % iron saturation, and total iron binding capacity
Baseline Characteristics		Patients with hemoglobin and MCV data (n= 73)
	Age 0-1	2 (3.0%)
	Age 1-5	22 (30%)
	Age 5-10	7 (9.5%)
	Age 10-15	10 (14%)
	Age 15-20	18 (25%)
	Age > 20	14 (19%)
	Male	26 (36%)
	Female	47 (64%)
Results		Pre-infusion	Post-infusion
	Hemoglobin (g/dL)	9.0	10.8
	Mean corpuscular volume (MCV)	70.3	75.6
	Ferritin (mcg/L)	7.0	41
	Total iron binding capacity (TIBC) (mcg/dL)	402	370
	Serum iron and % iron saturation increased substantially (numerical values not specified in study).
Adverse Events	One patient developed cough and wheezing during infusion, which resolved after stopping the infusion. No other adverse events or allergic reactions were reported.
Study Author Conclusions	IV iron sucrose is safe and effective for treating severe IDA in children, leading to significant increases in hemoglobin and iron studies. It should be considered for patients with severe IDA, poor compliance with oral formulations, and malabsorption.
Critique	The study's strengths include a relatively large sample size and comprehensive evaluation of iron studies. Limitations include its retrospective design, lack of uniform laboratory data for all patients, and variability in the number of IV iron sucrose infusions received by patients.

Table 4 References:
[6] Kaneva K, Chow E, Rosenfield CG, Kelly MJ. Intravenous Iron Sucrose for Children With Iron Deficiency Anemia. J Pediatr Hematol Oncol. 2017;39(5):e259-e262. doi:10.1097/MPH.0000000000000879

Safety and Efficacy of Intravenous Iron Sucrose for Iron-Deficiency Anemia in Children and Adolescents With Inflammatory Bowel Disease
Design	Retrospective, single-center study N= 88
Objective	To assess safety and efficacy of intravenous iron sucrose (IVIS) in children with irritable bowel disease (IBD)
Study Groups	Crohn’s disease ([CD], n= 52) Ulcerative colitis ([UC], n= 33) IBD-unclassified ([IBD-U], n= 3)
Inclusion Criteria	IBD patients younger than 22 years of age who received IVIS between July 2009 and October 2014
Exclusion Criteria	Courses excluded if patients underwent packed red blood cell transfusions 30 days before or after IVIS initiation, or if they did not meet criteria for iron deficiency anemia (IDA)
Methods	Medical records of IBD patients <22 years were reviewed. Anemia was defined by hemoglobin (Hgb) level below normal for age and gender. Efficacy was defined as ≥2 g/dL increase in Hgb ≤12 weeks from IVIS initiation. Safety was evaluated by monitoring adverse reactions during IVIS infusions.
Duration	July 2009 to October 2014
Outcome Measures	Primary: Increase in Hgb level Secondary: Safety of IVIS infusions
Baseline Characteristics		No Response (n = 33 courses)	Response (n = 47 courses)
	Age, median (IQR)	15 (13-18)	14 (12-16.5)
	Male, n (%)	20 (60.6)	22 (46.8)
	IBD - CD	24 (72.7)	26 (55.3)
	IBD - IBD-U	0 (0.0)	1 (2.1)
	IBD - UC	9 (27.3)	20 (42.6)
	Number of courses (mean ± SD)	1.6 ± 0.8	1.2 ± 0.4
	Single course, n (%)	20 (60.6)	39 (83.0)
	Total cumulative dose (mg), median (IQR)	300 (200-540)	400.00 (200-600)
	Dose (mg/kg/course), median (IQR)	6.4 (3.8-12)	7.7 (4.5-13.2)
	Baseline Hgb (mean ± SD)	9.9 ± 1.1	8.6 ± 1.4
	Highest Hgb within 12 weeks (mean ± SD)	10.8 ± 1.2	12.6 ± 1.6
	Increase Hgb from baseline (mean ± SD)	0.9 ± 0.7	4.1 ± 1.5
	CRP - Abnormal	16 (48.5)	27 (57.4)
	CRP - Normal	7 (21.2)	13 (27.7)
	CRP - N/A	10 (30.3)	7 (14.9)
	ESR - Abnormal	16 (48.5)	33 (70.2)
	ESR - Normal	3 (9.1)	4 (8.5)
	ESR - N/A	14 (42.4)	10 (21.3)
	Treatment location - Both inpatient and outpatient	5 (15.2)	7 (14.9)
	Treatment location - Inpatient	14 (42.4)	32 (68.1)
	Treatment location - Outpatient	14 (42.4)	8 (17.0)
	Abbreviations: CRP = C-reactive protein; ESR = erythrocyte stimulation rate. The 88 included patients underwent 329 IVIS infusions over 121 courses.
Results		No Response (n = 33 courses)	Response (n = 47 courses)	p-value
	Baseline Hgb (mean ± SD)	9.9 ± 1.1	8.6 ± 1.4	<0.0001
	Highest Hgb within 12 weeks (mean ± SD)	10.8 ± 1.2	12.6 ± 1.6	<0.0001
	Increase Hgb from baseline (mean ± SD)	0.9 ± 0.7	4.1 ± 1.5	<0.0001
	Multivariable analysis with adjustment to age and gender revealed that lower baseline Hgb was the only significant predictor of response to IVIS treatment (p≤ 0.0001), while patients who received 1 course vs 2 or more courses (p= 0.07) and those who received IVIS while inpatient vs outpatient or both (p= 0.06) had results approaching significance.
Adverse Events	Minor adverse reactions occurred in 6 patients, including painless edema at the IV site, transient change in urine color, and pain at the IV site. One episode of thrombophlebitis required antibiotic therapy. No episodes of anaphylaxis were reported.
Study Author Conclusions	IVIS is safe and effective in treating iron-deficiency anemia in pediatric IBD. Minor adverse events were observed, but the majority of patients achieved the goal hemoglobin increase.
Critique	The was a large study on IVIS in pediatric IBD, providing valuable data on safety and efficacy. However, its retrospective nature and missing data limit the robustness of the findings. Prospective studies are needed to confirm these results.

Table 5 References:
[7] Sabe R, Vatsayan A, Mahran A, Khalili AS, Ahuja S, Sferra TJ. Safety and Efficacy of Intravenous Iron Sucrose for Iron-Deficiency Anemia in Children and Adolescents With Inflammatory Bowel Disease. Glob Pediatr Health. 2019 Aug 18;6:2333794X19870981. doi:10.1177/2333794X19870981

Intravenous iron for critically ill children. Comparison of three dose regimens
Design	Prospective, observational, longitudinal, single-center cohort study N= 115
Objective	To examine the safety and efficacy of intravenous (IV) iron sucrose infusion to manage anemia in pediatric critical care and to examine the effect of different dose regimens of iron sucrose (3, 5, and 7 mg/kg/dose)
Study Groups	3 mg/kg/dose (n= 57) 5 mg/kg/dose (n= 49) 7 mg/kg/dose (n= 40)
Inclusion Criteria	Patients from 1 month to 16 years admitted to a single hospital's pediatric intensive care unit (PICU) who received IV iron therapy due to anemia (hemoglobin ≤2 standard deviations at their age) and iron deficiency
Exclusion Criteria	Septicemia
Methods	IV iron sucrose was administered at doses of 3, 5, or 7 mg/kg, diluted in 0.9% sodium chloride solution. The first mg/kg (maximum 50 mg) was administered over 30 minutes, followed by the rest of the infusion in another 30 minutes. Treatment was administered at least until PICU discharge
Duration	October 2017 to November 2022
Outcome Measures	Primary: Hemoglobin increase, improvement in transferrin saturation index (TSI) and serum iron Secondary: Iron deficit replacement percentage, adverse reactions
Baseline Characteristics		All patients (N= 115)
	Age, mean years (SD)	3.9 (5.1), range 1 month to 16 years
	Weight, mean kg (SD)	15.7 (16.1)
	Male	56%
	Cardiac diagnosis	73%
	Respiratory diagnosis	12%
	Neurologic diagnosis	4.3%
	Other diagnosis	10.7%
	Number of treatment courses 1 2 3 ≥4	95 (83%) 13 (11%) 5 (4.3%) 10
Results		3 mg/kg	5 mg/kg	7 mg/kg	p-value
	Iron deficit replacement (%)	77.5%	85.9%	94%	0.008
	Treatment duration (days)	11.3	6.4	4.5	<0.001
	After IV iron treatment, hemoglobin showed a significant increase within a 30-day follow-up (9.2 vs 11.6 g/dL, p< 0.001). There was also a significant improvement in TSI and serum iron (p< 0.001). The standard dose of 3 mg/kg per dose of iron sucrose was used in 57 treatment courses (39%), 5 mg/kg in 49 courses (34%), and 7 mg/kg in 40(27%).
Adverse Events	Very few mild adverse reactions were reported (1.3% of infusions), with no differences between groups. The most frequent adverse effect was gastrointestinal in three cases. There were no anaphylaxis-like or other serious/life-threatening adverse effects.
Study Author Conclusions	This is the first study to evaluate IV iron therapy in pediatric critical care, providing preliminary evidence of safety and efficacy of IV iron sucrose. The 7 mg/kg dose regimen showed higher iron deficit replacement in a shorter time, which could be beneficial in critically ill children.
Critique	The study provides valuable insights into the use of IV iron in critically ill children, showing safety and efficacy. However, it is limited by its single-center design and lack of a control group. The study's observational nature also limits the ability to draw causal conclusions. Further randomized controlled trials are needed to confirm these findings and establish stronger recommendations.

Table 6 References:
[8] Butragueo-Laiseca L, de la Mata Navazo S, Snchez Galindo AC, Santiago Lozano MJ. Intravenous iron for critically ill children. Comparison of three dose regimens. Pediatr Blood Cancer. 2024;71(1):e30734. doi:10.1002/pbc.30734

Treatment targeting pediatric inflammatory bowel disease-associated anemia: experience from a single tertiary center
Design	Retrospective study N= 63
Objective	To assess the safety and efficacy of iron sucrose (IS) and ferric carboxymaltose (FCM) in the treatment of ID and IDA in pediatric IBD
Study Groups	IS (n= 41) FCM (n= 63)
Inclusion Criteria	Pediatric patients with IBD aged 1–19 years treated with IV iron—IS < 14 years, FCM ≥ 14 years—for IDA or evidence of iron deficiency, between March 2011 and March 2021
Exclusion Criteria	Patients with concomitant vitamin B12 or folate deficiency, patients receiving oral iron throughout the study period, and pregnant patients
Methods	Retrospective review of medical records over 10 years. IS was administered to patients under 14 years, and FCM to those 14 years and older. The Ganzoni formula was used to calculate the iron dose. Efficacy was defined as a ≥2 g/dL rise in Hb or anemia resolution within 12 weeks for IDA, and transferrin saturation or ferritin normalization for ID. Adverse reactions were monitored during treatment and after discharge.
Duration	March 2011 to March 2021
Outcome Measures	Treatment efficacy (≥2 g/dL increase in Hb or normalization of Hb for IDA; TSAT or s-ferritin normalization for ID)
Baseline Characteristics		All patients (n= 63)
	Male	30/63 (47.6%)
	Age at IBD diagnosis, years	13.1 (0.4–17.9)
	Age at time of the first IV iron administration, years	14.6 (1.5–19)
	Crohn disease	41/63 (65.1%)
	Ulcerative colitis	15/63 (23.8%)
Results		FCM (n= 63)	IS (n= 41)
	Treatment efficacy in IDA	66.7%	67.6%
	Treatment efficacy in ID without anemia	77.8%	-
Adverse Events	One adverse reaction (hypotension and rash) was associated with IS treatment
Study Author Conclusions	In one of the largest and longest follow-up cohorts, FCM and IS were safe and effective for correcting ID in pediatric patients with IBD. As ID recurs frequently, proactive screening and treatment are important.
Critique	The study's retrospective design limits the ability to control for confounding variables and may lead to missing data. The lack of a comparison group treated with oral iron or placebo is a limitation. The study provides valuable long-term data on the safety and efficacy of IV iron in pediatric IBD, but prospective trials are needed to optimize dosing and treatment strategies.

Table 7 References:
[9] Fernandes ASC, Azevedo S, Martins AR, Lopes AI. Treatment targeting pediatric inflammatory bowel disease-associated anemia: experience from a single tertiary center. Clin Exp Pediatr. 2025 Sep;68(9):722-731. doi:10.3345/cep.2025.00640