Important Safety Information about Feraheme
Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.
In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects receiving Feraheme, including three patients with serious hypotensive reactions. Serious hypersensitivity reactions were reported in 0.2% (3/1726) of patients. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when treatment of hypersensitivity reactions is readily available. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging but will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients were diarrhea, nausea, dizziness, hypotension, constipation and peripheral edema.
About 3SBio Inc.
3SBio Inc. is a leading, fully integrated biotechnology company focused on
researching, developing, manufacturing and marketing biopharmaceutical
products, primarily in China. For more information, please visit 3SBio on the
|SOURCE 3SBio Inc.|
Copyright©2010 PR Newswire.
All rights reserved