Feraheme Labeling Updated
AMAG Pharmaceuticals announced that it has updated the labeling for Feraheme (ferumoxytol injection) to include additional post-marketing safety data. After review of safety data, AMAG is reverting back from a 60-minute monitoring period to a 30-minute period following administration of Feraheme.
Modifications have also been made to the Contraindications section removing “evidence of iron overload” and “anemia not caused by iron deficiency,” and to the Hypersensitivity Reactions language of the Warnings and Precautions section to include “serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme,” and “a decrease in the observation period to monitor patients for signs and symptoms of hypersensitivity during and following Feraheme administration from 60 minutes to 30 minutes.”Feraheme is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients.
For more information call (617) 498-3300 or visit www.feraheme.com.