PD-198 Safety and Efficacy of Ferric Carboxymaltose in Pediatric Inflammatory Bowel Disease

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Abstract

Background:

Iron deficiency anemia (IDA) is one of the most commonly encountered extra-intestinal manifestations of pediatric inflammatory bowel disease (IBD). Oral iron (Fe) replacement therapy is complicated by issues of adherence as well as decreased intestinal absorption of Fe in the face of intestinal inflammation. Intravenous (IV) iron has historically been complicated by adverse events often related to the carrier protein used as well as the need for the administration of multiple IV Fe doses. Ferric carboxymaltose (FCM) is a relatively new, high-dose formulation of IV Fe currently approved for IDA in adults. We report our retrospective experience with this agent in pediatric IBD patients.

Methods:

A retrospective chart review was performed of all patients who received infusion therapy at the Goryeb Children's Hospital IBD Center from January 2015 until June 2016. All patients who had received at least one infusion of FCM were identified. Data captured included patient demographics, dose of FCM administered, number of FCM infusions provided, pre-medications given, ability to complete the infusion and adverse events associated with infusion of FCM. In addition, lab parameters at baseline and 3 months after FCM therapy were collected including hemoglobin (Hgb), serum iron and serum ferritin.

Results:

During the time of study, 57 patients received a total of 79 FCM infusions. Forty three (75%) had Crohn disease; 31 (54%) were female; ages were 3 to 22 years (mean 15 yr). Thrity-seven patients (65%) received one FCM dose and 18 (32%) received 2 doses provided 2 to 4 weeks apart. Thriteen (23%) had been previously proven to be refractory to oral iron. FCM dose used was 15 mg·kg−1·dose−1 to a maximum of 750 mg/dose. Seventy seven doses were preceded by an anti-histamine (76 loratadine, 1 diphenhydramine). Mean baseline Hgb was 10.01 g/dL and mean Hgb change 3 months after FCM therapy was + 2.33 g/dL; mean baseline Fe was 36 μg/dL and mean Fe change at 3 months was + 17.20 μg/dL; mean baseline serum ferritin was 74.0 μg/L and mean 3 month ferritin change was + 33.5 μg/L. Overall, 77 of the 79 infusions (97%) were completed with no adverse reaction recorded. In 2 cases where no pre-medications were administered immediately prior to the infusion, dyspnea developed. One of these infusions was completed after a subsequent dose of IV diphenhydramine, the other patient refused completion of the FCM infusion after being given IV diphenhydramine and recovered without sequelae.

Conclusion:

FCM allows for rapid IV iron replacement in pediatric IBD patients. The agent is overall well tolerated and pre-treatment with anti-histamines should be considered when this therapy is administered.

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