<p><strong>Hypersensitivity Reactions</strong>: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric Derisomaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric Derisomaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Ferric Derisomaltose is contraindicated in patients with prior serious hypersensitivity reactions to Ferric Derisomaltose or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Ferric Derisomaltose treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.<br />
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<strong>Iron Overload</strong>: Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Ferric Derisomaltose to patients with iron overload</p>