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P212. Pharmacokinetics of iron isomaltoside 1000 in inflammatory bowel disease (IBD)

K. Nordfjeld, L.L. Thomsen

Pharmacosmos A/S, Holbaek, Denmark

Introduction: Iron deficiency anemia (IDA) is the most common type of anemia associated with IBD. Intravenous iron appears to be more effective, better tolerated, and improves the quality of life to a greater extent than oral iron supplements in these patients. This open-label, randomised, cross-over, single centre trial was conducted to establish the pharmacokinetics of iron isomaltoside 1000 – a new parenteral iron with strongly bound iron within the iron-isomaltoside formulation and thus little risk of free iron toxicity and with low immunological potential of the isomatoside 1000.

Methods: 12 Subjects were randomised and received 100 mg and 200 mg iron isomaltoside 1000 given as a single bolus dose at an injection rate of maximum 50 mg of iron/minute, with at least 4 weeks wash out time in a randomised cross over design. PK-variables (isomaltoside bound iron) included AUC, Cmax and T1/2.

Results: The T1/2 for isomaltoside bound-iron was 0.9 days for both doses. Cmax reached 680 μmol/L and 1300 μmol/L for the two doses respectively. The iron PK profiles and analysis showed a higher AUC and Cmax for the 200 mg dose compared to the 100 mg dose. Elimination constant and T1/2 were found to be the same for both the doses. Overall approximately 1% of the doses administered were excreted in the urine (0.86% after the 100 mg dose and 1.07% following the 200 mg dose). No serious adverse events or other significant adverse events were reported, neither any changes in laboratory parameters nor in vital signs. One subject was withdrawn after the 100 mg dose due to abdominal pain and flushing.

Conclusions: Iron isomaltoside 1000 (100 mg and 200 mg) showed an expected dose dependent kinetic and was also shown to be safe in the administered doses in the inflammatory bowel disease patient group.