As part of our mission, we’re working to address complications of kidney disease and we currently market AURYXIA® (ferric citrate) in the U.S. for its two approved indications:
The control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis
The treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.
Important Safety Information
CONTRAINDICATION
AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis
WARNINGS AND PRECAUTIONS
Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy
Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children
ADVERSE REACTIONS
The most common adverse reactions reported with AURYXIA in clinical trials were:
Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)
Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%)
SPECIFIC POPULATIONS
Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman
To report suspected adverse reactions, contact Akebia at 1-844-445-3799.
Please see full Prescribing Information
Learn more at AURYXIA.com.
Patient Resources
We recognize that many patients today face financial obstacles that keep them from accessing important medications. We believe these medications should be available to every patient who needs them. In the United States, we have put in place a patient services program that provides one-on-one support to help communicate individual benefits and available resources.
For more information about our AkebiaCares program, please call (855) 686-8601 or visit the AkebiaCares webpage.
DSE-US-0065
Akebia Therapeutics, Inc.
245 First Street, Suite 1400
Cambridge, MA 02142
+1 617.871.2098 phone
+1 617.871.2099 fax