Full Prescribing Information

Important Safety Information about Feraheme

Feraheme can only be administered by a doctor or nurse as an intravenous injection. Feraheme is not for people with high iron levels, people known to be allergic to Feraheme or any of its ingredients, or people with anemia not caused by iron deficiency.

Treatment with Feraheme can cause serious allergic reactions. When tested in clinical trials, three out of 1,726 people who received Feraheme had a serious drop in blood pressure. Sixty-three additional people had other adverse reactions that may have been related to an allergic reaction. These included itching, rash, hives, and wheezing.

After receiving Feraheme, you should be watched by a doctor or nurse for at least 30 minutes to make sure you do not have an allergic reaction or a drop in blood pressure.

Receiving Feraheme may affect magnetic resonance imaging (MRI) for up to three months. Ultrasound, x-ray, and other imaging are not affected.

After receiving Feraheme, you may have diarrhea, nausea, dizziness, low blood pressure, constipation, and swelling of the arms and legs. If you develop any of these conditions, tell your doctor or nurse.

You are encouraged to report side effects of prescription drugs to the FDA by calling 1-800-FDA-1088 or going online to the Web Site www.fda.gov/medwatch.

Please read the full Prescribing Information before receiving Feraheme.