New Indication for Feraheme
February 2, 2018 – The U.S. FDA has approved a new indication for Feraheme® (ferumoxytol) injection, manufactured by AMAG Pharmaceuticals. Originally approved in 2009 to treat adults who have anemia and chronic kidney disease, Feraheme is now approved to treat any adult who has iron deficiency anemia and has intolerance toward or has failed to respond to oral iron replacement therapy.
The new indication is based on clinical trials in which patients who received Feraheme experienced a mean improvement in hemoglobin per gram of iron administered, compared to baseline. Feraheme was found in these studies to be comparable to Daiichi Sankyo’s Injectafer® (ferric carboxymaltose injection) in terms of its safety profile.
Recommended dosing with Feraheme is two 510mg intravenous (IV) fifteen-minute infusions given three to eight days apart. The drug carries a black box warning that its use may lead to serious hypersensitivity reactions or anaphylaxis. Due to these risks, Feraheme should be administered at a medical facility where hypersensitivity reactions or anaphylaxis can be immediately addressed by properly trained staff. Patients should be monitored for at least 30 minutes following infusion. Even if a patient has tolerated Feraheme well in the past, they may still be at risk for hypersensitivity and anaphylaxis as a result of treatment.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.