For the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis

Need a different choice for IDA in CKD-NDD?
Reach for AURYXIA.

CKD=chronic kidney disease; IDA=iron deficiency anemia; NDD=non-dialysis dependent. *Not specifically indicated.

AURYXIA is the first oral iron specifically indicated for adults with CKD not on dialysis1

AURYXIA has been proven to increase Hb and iron parameters (TSAT and ferritin) with a starting dose of 1 tablet 3 times a day.1-4†‡ So your clinical interests—and your patients’ interests—line up.

In the clinical trial:

  • Mean Hb increased from 10.4 g/dL to 11.4 g/dL by the end of the 16-week period2,3
  • Mean TSAT increased from 20.2% at baseline to 35.6% at Week 164
  • Patients on AURYXIA also achieved a mean increase in serum ferritin of 163 ng/mL from baseline (85.9 ng/mL) at Week 161,2

SEE TRIAL DESIGN

Hb=hemoglobin; TSAT=transferrin saturation.
IV iron use and ESA use were not allowed per trial design and exclusion criteria.1
In the clinical trial, patients required an average of 5 tablets per day to increase hemoglobin levels.

IMPORTANT SAFETY INFORMATION AND INDICATION

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:

  • 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

INDICATION

AURYXIA® (ferric citrate) is indicated for:

  • The treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis

To report suspected adverse reactions, contact Akebia Therapeutics, Inc. at 1-844-445-3799

Please see full Prescribing Information

REFERENCES

  1. AURYXIA® [Package Insert]. Cambridge, MA: Akebia Therapeutics, Inc. 2021.
  2. Fishbane S, Block Ga, Loram L, et al. Effects of ferric citrate in patients with nondialysis-dependent CKD and iron deficiency anemia. J Am Soc Nephrol. 2017;28(6):1851-1858.
  3. Data on File 16, Akebia Therapeutics, Inc.
  4. Data on File 14, Akebia Therapeutics, Inc.