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Why choose AURYXIA?

Efficacy

AURYXIA was proven effective in patients who were previously intolerant of, or had an inadequate therapeutic response to, traditional oral iron supplements1

  • The primary end point was the proportion of patients achieving an increase in hemoglobin (Hgb) concentration of ≥ 1.0 g/dL from baseline at any time point during the 16-week efficacy period (52% [n=117] of AURYXIA-treated patients vs 19% [n=115] placebo; P<0.001)1
  • Mean Hgb increased from 10.4 g/dL to 11.4 g/dL by the end of the 16-week trial2,3
  • Hgb increases were seen as early as 1 to 2 weeks2

Tolerability and safety profile

Patients prescribed AURYXIA experienced similar discontinuation rates due to adverse reactions compared with placebo1

  • During the 16-week randomized period of the pivotal trial, there was a similar rate of discontinuation due to adverse reactions between the AURYXIA (n=117) and placebo (n=116) groups (10% vs 9%, respectively). The most common adverse reaction leading to discontinuation of AURYXIA was diarrhea (2.6%)1
  • The most common adverse event reported during this randomized period was diarrhea (20.5%), the majority of which was mild to moderate in severity2,4
  • In a pooled analysis from 2 clinical trials, the most common adverse reactions (incidence ≥ 5%) in patients treated with AURYXIA were discolored feces, diarrhea, constipation, nausea, abdominal pain, and hyperkalemia.1 Please see Important Safety Information below and Full Prescribing Information

Dosing

AURYXIA contains 210 mg of elemental iron per tablet and offers convenient mealtime dosing1

  • Starting dose: 1 tablet orally 3 times per day with meals1
  • Adjust dose as needed to achieve and maintain Hgb goal1

Trial design

A 16-week, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AURYXIA for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis. Patients were randomized to treatment with either AURYXIA (n=117) or placebo (n=117), had Hgb levels ≥ 9.0 g/dL and ≤ 11.5 g/dL, had serum ferritin levels ≤ 200 ng/mL, had transferrin saturation levels ≤ 25%, and were previously intolerant of, or had inadequate therapeutic response to, traditional oral iron supplements.1

Secondary efficacy end points included mean changes in Hgb, transferrin saturation, ferritin, and phosphorus from baseline to week 16; and proportion of patients experiencing a sustained treatment effect on Hgb (defined as ≥ 0.75 g/dL mean change in Hgb from baseline over any 4-week period provided that an increase of at least 1.0 g/dL had occurred during that 4-week period).2

Use of oral or intravenous iron, and erythropoiesis-stimulating agents was not permitted at any time during the trial.1

Please see Important Safety Information below and Full Prescribing Information.

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AURYXIA is on formulary for a majority of commercial plans, with no prior authorizations or step edits required.

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Our Copay Program helps eligible patients with commercial insurancea receive AURYXIA for as little as $0 per fill.

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Our Patient Support Program offers personalized support for your patients, including help with reimbursement and access options for AURYXIA.b,c

Help your patients save on their AURYXIA prescriptiona

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  1. aCopay assistance is not valid for prescriptions reimbursed under Medicare, Medicaid, or other similar federal or state programs.
  2. bPatients may be eligible for Low-Income Subsidy if they have an income ≤ 150% of the Federal Poverty Level.
  3. cIndividual restrictions and eligibility requirements may apply.

Anemia is common in people with CKD not on dialysis5

Facts to consider when treating iron deficiency anemia in your practice

30 million

The number of adults in the United States estimated to have CKD6

2x

Anemia is twice as prevalent in people with CKD than in the general population (15.4% vs 7.6%, respectively)5

96%

The percentage of people with kidney damage or mildly reduced kidney function that are not aware of having CKD6

Almost half

48% of those with severely reduced kidney function but not on dialysis are not aware of having CKD6

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:

  • 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 Therapeutics at 1-844-445-3799

Click here to see Full Prescribing information

Review more data and details

Visit Auryxia.com review data

References: 1. Auryxia [package insert]. Boston, MA: Keryx Biopharmaceuticals, Inc.; 2017. 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. doi:10.1681/ASN.2016101053. 3. Data on File 16. Akebia Therapeutics. 4. Data on File 13. Akebia Therapeutics. 5. Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in the United States. PLoS One 2014;9(1):e84943. doi:10.1371/journal.pone.0084943. 6. Centers for Disease Control and Prevention. National chronic kidney disease fact sheet, 2017. https://www.cdc.gov/kidneydisease/pdf/kidney_factsheet.pdf. Accessed December 14, 2018.