Important Safety Information | Full Prescribing Information

FOR US HEALTHCARE PROFESSIONALS

AURYXIA® Logo
KME headshot

I am often concerned about calcium load in my patients with chronic kidney disease taking calcium-based phosphate binders. For my patients in Texas with CKD on dialysis, I choose AURYXIA due to its strong phosphorous control in an iron-based, non-calcium tablet.

— German Hernandez, MD, FASN, FACP

Partner at El Paso Kidney Specialists

El Paso, TX

This content is developed and funded by Akebia.

SELECT IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis

Please see additional Important Safety Information below.

KDIGO=Kidney Disease Improving Global Outcomes.

*IQVIA prescription sales data from 2017-June 2022.

AURYXIA has been prescribed by healthcare providers for more than 8 years, helping patients get to goal.1‡

  • NEARLY 200,000 PATIENTS have been prescribed AURYXIA since launch5§
  • NEARLY 10,000 HEALTHCARE PROFESSIONALS have prescribed AURYXIA6

‡Kidney Disease Outcomes Quality Initiative (KDOQI) recommended serum phosphorus target range=3.5-5.5 mg/dL.7

§Estimate based on US claims and dispensed data from 2015 to 2022.5

AURYXIA has demonstrated strong and sustained efficacy as a monotherapy in a clinical trial1,4

In a 56-week trial, AURYXIA delivered strong phosphorus control in an iron-based, non-calcium tablet.1,4

AURYXIA had similar reductions in serum phosphorus compared to Active Control4||

Secondary endpoint: treatment difference of 0.02 mg/dL at Week 52 (P=0.89)

Secondary endpoint graphic for AURYXIA®

AURYXIA maintained significant reductions in serum phosphorus compared to placebo4

Primary endpoint: treatment difference of -2.18 mg/dL at Week 56 (P<­0.0001­)

Primary endpoint graphic for AURYXIA®

AURYXIA Arm Re-randomization

||Active Control=sevelamer carbonate and/or calcium acetate.

Patients on AURYXIA maintained mean serum phosphorus levels between 3.5-5.5 mg/dL after a year of treatment (up to 56 weeks)1,4

  • Patients on AURYXIA had a mean serum phosphorus level of 7.41 mg/dL at baseline and 4.88 mg/dL at Week 564

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. The safety and efficacy of AURYXIA was studied in the 52-week Active Control Period (AURYXIA n=292, Active Control n=149). Eligible patients had serum phosphorus ≥2.5 and ≤8.0 mg/dL, ferritin <­1000 ng/mL, and TSAT <­50% at the screening visit. Phosphate binders other than the study drugs were not permitted during the study. 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 during weeks 52-56 (AURYXIA n=96, Placebo n=96). The primary endpoint was the change in serum phosphorus from baseline (Week 52) to Week 56 between AURYXIA and placebo. The secondary endpoint was the change in serum phosphorus from baseline to Week 52 between AURYXIA and Active Control. Phosphate binders other than the study drugs were not permitted during the study.

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

KME headshot

I am confident choosing AURYXIA for the control of serum phosphorous levels in my patients in Texas with chronic kidney disease on dialysis. In the 56-week pivotal trial, AURYXIA demonstrated strong and sustained phosphorous reduction to between 3.5-5.5 mg/dL.

— German Hernandez, MD, FASN, FACP

Partner at El Paso Kidney Specialists

El Paso, TX

This content is developed and funded by Akebia.

3 of 5Nephrologists
have prescribed AURYXIA
for their patients.9¶

3 of 5 nephrologists graphic

Amongst nephrologists who have prescribed phosphate binders. Timeframe between January 1, 2020 and October 31, 2022.
Data accessed on 11/2/22.

Percentage of patients achieving serum phosphorus levels of ≤5.5 mg/dL10#

Percentage of patients achieving serum phosphorus levels
Percentage of patients achieving serum phosphorus levels of ≤5.5 mg/dL week 12
Percentage of patients achieving serum phosphorus levels of ≤5.5 mg/dL week 52
Percentage of patients achieving serum phosphorus levels of ≤5.5 mg/dL week 56

#Based on the exploratory endpoint data. The statistical tests performed for the exploratory endpoint data were not adjusted for potential errors and were for descriptive purposes only.

AURYXIA helped patients reach and maintain serum phosphorous levels between 3.5-5.5 mg/dL for more than a year of treatment (56 weeks)4

KME headshot

Controlling hyperphosphatemia can be a constant struggle. AURYXIA is an iron-based, non-calcium tablet that I use to manage hyperphosphatemia in my patients in Texas with chronic kidney disease on dialysis. This film-coated tablet is swallowed whole, with no discoloration of the mouth.

— German Hernandez, MD, FASN, FACP

Partner at El Paso Kidney Specialists

El Paso, TX

This content is developed and funded by Akebia.

Did you know that
patients on dialysis may
be taking an average of
19 pills a day?11

pill count per day graphic image

AURYXIA is uniquely formulated for your patients:

  • An iron-based, non-calcium tablet1
  • Film-coated tablet that is swallowed, not chewed or crushed1
No discolorationNo discoloration of the mouth when
swallowed whole1

Dosing guidelines1

AURYXIA is taken with meals graphic
Starting dose 2 tablets swallowed whole 3x/day graphic
Adjust dose every week (or longer) as needed graphic
Maximum dose 12 tablets daily graphic

Titration guidelines

Titration guidelines graphic
Titration guidelines graphic

Oral drugs that cannot be taken at the same time as AURYXIA

  • Doxycycline—Take at least 1 hour before AURYXIA1
  • Ciprofloxacin—Take at least 2 hours before or after AURYXIA1
  • For oral medications where a reduction in bioavailability would have a clinically significant effect, consider separation of timing of administration with AURYXIA1

AURYXIA is a phosphate binder with a proven safety and tolerability profile1

A pooled safety analysis included a 52-week pivotal study1

The most common adverse reactions reported with AURYXIA table

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 onset1,12-14

Safety and tolerability profile evaluated in a 52-week trial1,15

41.9% of patients on AURYXIA experienced an SAE compared to 49.7% on Active Control14

- No individual SAEs were observed in more than 5% of patients treated with AURYXIA14

Safety and tolerability profile evaluated in a 52-week trial table

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

SAFETY (PHARMACODYNAMICS): AURYXIA has been shown to increase iron parameters, including TSAT and ferritin1

  • AURYXIA has a warning for iron overload which may lead to excessive elevation in iron stores; serum ferritin and TSAT should be assessed prior to initiating AURYXIA and monitored while on therapy1

- During the 52-week Active Control Period in the Phase III trial in which concomitant use of IV iron was permitted1:

– Gradual increases in iron parameters occurred over the first 3-6 months and then plateaued16

Assess iron parameters prior to initiating AURYXIA as a phosphate binder and monitor while on therapy1

AND

In patients receiving IV iron, a reduction in dose or discontinuation of IV iron therapy may be required1

Mean TSAT levels for AURYXIA vs Active Control

Mean TSAT increased from 31.3% at baseline to 39.2% at Week 52 (~8%)

**Active Control=sevelamer carbonate and/or calcium acetate.

Mean serum ferritin levels for AURYXIA vs Active Control

Mean serum ferritin increased from 593 ng/mL at baseline to 895 ng/mL at Week 52 (302 ng/mL)

**Active Control=sevelamer carbonate and/or calcium acetate.

IV=intravenous; TSAT=transferrin saturation.

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:

  • 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. 2. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney International Supplements. 2017;7(1):1-59. Accessed 08-30-2022. https://kdigo.org/wp-content/uploads/2017/02/2017-KDIGO-CKD-MBD-GL-Update.pdf 3. Data on File 38, Akebia Therapeutics, Inc. 4. Data on File 1, Akebia Therapeutics, Inc. 5. Data on File 34, Akebia Therapeutics, Inc. 6. Data on File 32, 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 Suppl3):S1-S201. doi:10.1053/S0272-6386(03)00905-3­ 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. 9. Data on File 37, Akebia Therapeutics, Inc. 10. Data on File 33, Akebia Therapeutics, Inc. 11. Chiu YW, Teitelbaum I, Misra M, de Leon EM, Adzize T, Mehrotra R. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol. 2009;4(6):­1089-1096. doi:10.2215/CJN.00290109­ 12. Data on File 4, Akebia Therapeutics, Inc. 13. Data on File 11, Akebia Therapeutics, Inc. 14. Data on File 6, Akebia Therapeutics, Inc. 15. Data on File 10, Akebia Therapeutics, Inc. 16. Umanath K, Jalal DI, Greco BA, et al; for Collaborative Study Group. Ferric citrate reduces intravenous iron and erythropoiesis-stimulating agent use in ESRD. J Am Soc Nephrol. 2015;26(10):­2578-2587. 17. Data on File 2, Akebia Therapeutics, Inc.