AURYXIA has a proven safety profile

Explore the safety and tolerability profile for AURYXIA to see if it is right for your adult patients.1

Safety and tolerability profile evaluated in a pivotal clinical trial1

AURYXIA had a similar tolerability profile as placebo during the 16-week randomized period1,2

Discontinuation rates due to adverse reactions1AURYXIA
(N=117)
PLACEBO
(N=116)
12 (10%)10 (9%)
  • The most common adverse reaction leading to discontinuation of AURYXIA was diarrhea at 2.6%1
  • The most common adverse event was diarrhea (20.5%), the majority of which was mild to moderate in severity2,3

Safety and tolerability profile evaluated in two clinical trials1*

Adverse reactions reported in at least 5% of patients treated with AURYXIAAURYXIA %
(N=190)
Placebo %
(N=188)
Any Adverse Reaction7562
Metabolism and Nutrition Disorders
Hyperkalemia53
Gastrointestinal Disorders
Discolored Feces220
Diarrhea2112
Constipation1810
Nausea104
Abdominal Pain52

*Data from a study of 117 patients treated with AURYXIA and 116 patients treated with placebo in a 16-week, randomized, double-blind period and a study of 75 patients treated with AURYXIA and 73 treated with placebo in a 12-week randomized double-blind period. Dosage regimens in these trials ranged from 210 mg to 2,520 mg of ferric iron per day, equivalent to 1 to 12 tablets of AURYXIA.

The incidence of GI-related adverse events declined over time

Pooled analysis of GI AEs over 16 weeks4

AURYXIA (N=190)

PLACEBO (N=188)

Safety and tolerability profile evaluated in a pivotal clinical trial1

Similar incidence of severe adverse events (SAEs) between AURYXIA and placebo groups during the 16-week randomized period1,2

No individual SAEs were observed in more than 5% of patients treated with AURYXIA.

SAEs during the 16-week randomized period2AURYXIA
(N=117)
PLACEBO
(N=116)
14 (12.0%)13 (11.2%)

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SAFETY: PHARMACODYNAMICS

Trial design1

In a 24-week study consisting of a 16-week, randomized, double-blind, placebo-controlled efficacy period followed by an 8-week, open-label safety extension period, this trial evaluated the efficacy and safety of AURYXIA for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis. Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements, with hemoglobin ≥9.0 g/dL and ≤11.5 g/dL, serum ferritin ≤200 ng/mL, and TSAT ≤25% were enrolled. Patients were randomized to treatment with either AURYXIA (n=117) or placebo (n=117).

The primary endpoint was the proportion of patients achieving a ≥1.0 g/dL increase in hemoglobin at any time point during the 16-week efficacy period. Use of oral iron, IV iron, or ESAs was not permitted at any time during the trial.

AE=adverse event; CKD=chronic kidney disease; GI=gastrointestinal; SAE=serious adverse event.

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 13, Akebia Therapeutics, Inc.
  4. Chertow GM, Block GA, Neylan JF, Pergola PE, Uhlig K, Fishbane S. Safety and efficacy of ferric citrate in patients with nondialysis-dependent chronic kidney disease. PLoS One. 2017;12(11): e0188712. doi: 0.1371/journal.pone.0188712.
  5. Supplement to: 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.
  6. Data on File 16, Akebia Therapeutics, Inc.
  7. Data on File 14, Akebia Therapeutics, Inc.
  8. Data on File 24, Akebia Therapeutics, Inc.