New Indication for Auryxia
November 6, 2017 – The U.S. FDA has approved a new indication for Auryxia® (ferric citrate), manufactured by Keryx Biopharmaceuticals, for the treatment of iron deficiency in patients who have chronic kidney disease (CKD) but are not in need of dialysis treatment. Originally approved to control serum phosphorous levels in patients with CKD who are on dialysis, Auryxia binds phosphorous and can act as an iron replacement. Iron is needed to maintain proper hemoglobin levels in the body.
Recommended dosing for Auryxia is determined by the indication. In patients being treated for iron deficiency who are not on dialysis, the recommended starting dose is one tablet taken three times daily with meals. The dosage can be increased up to a maximum of 12 tablets daily if needed to maintain desired hemoglobin levels.
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.