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

A pooled safety analysis that included a 52-week pivotal study1

The most common adverse reactions reported with AURYXIA were1:

Adverse reactions in >5% of patientsAURYXIA
N=557
Diarrhea21%
Discolored feces19%
Nausea11%
Constipation8%
Vomiting7%
Cough6%

In a pooled safety analysis of the 52-week pivotal study and 3 short-term trials (N=557), the majority of diarrhea cases (56%) resolved within 2 weeks from onset1-3,5

Safety and tolerability profile evaluated in a 52-week trial1,4

41.9% of patients on AURYXIA experienced a serious adverse event (SAE) compared to 49.7% on Active Control (sevelamer carbonate and/or calcium acetate)5

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

SAEs occurring in ≥10% of patients taking AURYXIA vs Active Control by system organ class3AURYXIA
N=289		ACTIVE CONTROL
N=149
Gastrointestinal disorders7.6%12.8%
Cardiac disorders7.6%11.4%
Infection and infestations13.8%19.5%

Active Control=sevelamer carbonate and/or calcium acetate; SAE=serious adverse event.

See how AURYXIA helped patients reach their target goals

AURYXIA helped patients reach and stay in the range of 3.5-5.5 mg/dL during a 56-week trial.6,7
Patients had a mean serum phosphorus level of 7.41 mg/dL at baseline and 4.88 mg/dL at Week 56.6

EXAMINE EFFICACY

See trial design

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SAFETY: PHARMACODYNAMICS

Trial design1,8

A multicenter, randomized, open-label, Phase III trial evaluated the safety and efficacy of AURYXIA as a phosphate binder in controlling serum phosphorus levels in adult patients with CKD on hemodialysis and peritoneal dialysis over 56 weeks. Eligible patients were on dialysis for ≥3 months before screening, were prescribed 3 to 18 pills/day of commercially available phosphate binder, and had serum ferritin <1000 ng/mL, serum TSAT <50%, and serum phosphorus ≥2.5 and ≤8.0 mg/dL at the screening visit. Patients who were intolerant to calcium acetate and sevelamer carbonate were not included in the trial.

The safety and efficacy of AURYXIA was studied in the 52-week Active Control Period (AURYXIA n=292, Active Control n=149). At the final Active Control Period visit, AURYXIA patients were re-randomized to either continue AURYXIA treatment or receive placebo as part of the Placebo-Controlled Period (AURYXIA n=96, placebo n=96). The primary endpoint of the pivotal trial was the change in serum phosphorus from baseline (Week 52) to Week 56 between AURYXIA and placebo in the 4-week Placebo-Controlled Period.

CKD=chronic kidney disease; TSAT=transferrin saturation; Active Control=sevelamer carbonate and/or calcium acetate.

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:

  • Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)

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 control of serum phosphorus levels in adult patients with chronic kidney disease 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. Data on File 4, Akebia Therapeutics, Inc.
  3. Data on File 11, Akebia Therapeutics Inc.
  4. Data on File 10, Akebia Therapeutics Inc.
  5. Data on File 6, Akebia Therapeutics Inc.
  6. Data on File 1, Akebia Therapeutics Inc.
  7. National Kidney Foundation, K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(4 Suppl 3):S1-S201.
  8. Umanath K, Sika M, Niecestro R, et al; for Collaborative Study Group. Rationale and study design of a three period, 58-week trial of ferric citrate as a phosphate binder in patients with ESRD on dialysis. Hemodial Int. 2013;17(1):67-74.