Red blood cells
The US Food and Drug Administration (FDA) has expanded the approved indication for ferumoxytol injection (Feraheme®).
The drug is now approved to treat adults with iron deficiency anemia (IDA) who cannot tolerate or have had an unsatisfactory response to oral iron.
Ferumoxytol injection was previously approved by the FDA to treat IDA in adults with chronic kidney disease.
“Iron deficiency anemia is a serious and under-treated health condition which negatively impacts quality of life for millions of people, many of whom do not benefit from or cannot tolerate oral iron therapy,” said Michael Auerbach, MD, of Georgetown University School of Medicine in Washington, DC.
“Physicians now have a new option for patients who meet the broader ferumoxytol injection indication that can be administered in 15 minutes, providing a gram of iron in 2 doses as few as 3 days apart.”
The expanded approval for ferumoxytol injection was supported by a trio of phase 3 trials. All 3 trials included IDA patients who could not tolerate or had an unsatisfactory response to oral iron.
In the first trial (NCT01114139), researchers compared ferumoxytol injection to placebo.
The second trial (NCT01114204) was a comparison of ferumoxytol injection and iron sucrose.
In the third trial (NCT02694978), researchers compared ferumoxytol injection to ferric carboxymaltose injection (Injectafer®).
Details on these trials are included in the prescribing information for ferumoxytol injection, which is available at www.feraheme.com.
The prescribing information includes a boxed warning detailing the risk of fatal and serious hypersensitivity reactions, including anaphylaxis, in patients receiving ferumoxytol injection.
Ferumoxytol injection is a product of AMAG Pharmaceuticals, Inc.
The company has a patient access support program called AMAG Assist™. Uninsured or underinsured patients who need help paying for their ferumoxytol injection prescription can call 844-635-2624 to see if they qualify for help.
