FOR US HEALTHCARE PROFESSIONALS

For the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis

Who may be appropriate for AURYXIA?

There are many options when it comes to prescribing a treatment for hyperphosphatemia.

AURYXIA is contraindicated in patients with iron-overload syndromes (eg, hemochromatosis).

Patients to consider for AURYXIA

Adults with CKD receiving dialysis in need of phosphorus control who:

  • Are above the target phosphorus range per clinical guidance or
  • May be non-compliant with their current binder or
  • Prefer non-chewable tablets or
  • Have concerns about calcium-based binders or
  • Are on in-center or home dialysis

CKD=chronic kidney disease.

A male patient in a dark gray t-shirt sits with his forearms on his knees

Hypothetical patient profile. Not actual patient.

About Derrick:

  • 65-year-old retired firefighter
  • Diagnosed with hyperphosphatemia due to CKD 6 months ago
  • Enjoys cooking and spending time with his 2 grandchildren

About His Hyperphosphatemia Management:

  • Derrick has been taking a phosphate binder for the past 3 months and has struggled to reach his goal
    • HCP is not pleased with his phosphorus levels (6.5 mg/dL)
    • His current phosphate binder dose requires 9 pills a day
    • Phosphorus levels are still at 6.5 mg/dL
    • HCP is looking for an alternative treatment option

Medical History:

  • Currently undergoing in-center dialysis treatment
  • HCP concerned about additional phosphate binder dose increases
  • Prefers swallowing his medications
  • Receiving intravenous (IV) iron
  • No history of iron overload syndrome

Recent Lab Results*:

  • Phosphorus levels have remained around 6.5 mg/dL over the past 3 months. Most recent level was 6.3 mg/dL
  • PTH – 400 pg/mL
  • Calcium – 9.5 mg/dL
  • TSAT was at 25% 6 months ago and is now at 32%
  • Ferritin has ranged from 550 ng/mL to 650 ng/mL over the past 6 months
  • Hemoglobin increased from 12 g/dL to 12.5 g/dL over the past 6 months

PTH=parathyroid hormone; TSAT=transferrin saturation.

*Regular laboratory monitoring is part of routine clinical practice in patients with hyperphosphatemia due to CKD.2

A male patient in a dark gray t-shirt sits with his forearms on his knees

Hypothetical patient profile. Not actual patient.

A female patient in a black blouse stands with her hands on her hips

Hypothetical patient profile. Not actual patient.

About Maria:

  • 45 years old
  • Works full-time
  • Recently diagnosed with hyperphosphatemia due to CKD
  • Enjoys outdoor activities

About Her Hyperphosphatemia Management:

  • Not currently on any phosphate binder
    • Phosphorus levels at 7.2 mg/dL
  • Following prescribed low-phosphorus diet

Medical History:

  • Initiated peritoneal dialysis 1 month ago
  • Prefers swallowing her medications
    • Concerned with her teeth yellowing and/or staining
  • Receiving intravenous (IV) iron
  • No history of iron overload syndrome

Recent Lab Results*:

  • Phosphorus trending upward for the past 6 months from 6.5 mg/dL to 7.2 mg/dL
  • PTH – 450 pg/mL
  • Calcium – 9.5 mg/dL
  • TSAT at 38%
  • Ferritin at 575 ng/mL
  • Hemoglobin – 11 g/dL

PTH=parathyroid hormone; TSAT=transferrin saturation.

*Regular laboratory monitoring is part of routine clinical practice in patients with hyperphosphatemia due to CKD.2

A female patient in a black blouse stands with her hands on her hips

Hypothetical patient profile. Not actual patient.

A headshot of a smiling female patient in a striped shirt

“

“ When I see a patient who has uncontrolled phosphorus, I will typically take the opportunity of starting the patient on AURYXIA.”

– Constance Nicastro-Bowman, CNP Nurse PractitionerHear from your peers on why they prescribe AURYXIA

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.1
Patients had a mean serum phosphorus level of 7.41 mg/dL at baseline and 4.88 mg/dL at Week 56.3

EXAMINE EFFICACY

See trial design

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MECHANISM OF ACTION

Trial design1,4

A multicenter, randomized, open‐label trial evaluated the ability of AURYXIA to lower serum phosphorus in patients with CKD on dialysis over 56 weeks. Eligible patients had serum ferritin <1000 ng/mL, serum TSAT <50%, and serum phosphorus ≥2.5 and ≤8.0 mg/dL at the screening visit. The safety and efficacy of AURYXIA were studied in the 52‐week active‐controlled period (AURYXIA n=292, Active Control n=149), then AURYXIA patients were re‐randomized to either continue AURYXIA treatment or receive placebo during the placebo‐controlled period, 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 key secondary endpoint was the change in serum phosphorus from baseline (Week 0) to Week 52 between AURYXIA and Active Control.

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:

  • 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

DRUG INTERACTIONS

When clinically significant drug interactions are expected, e.g., Ciprofloxacin or Doxycycline, separate timing of administration.

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. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl. 2017;7(1):1-59. doi:10.1016/j.kisu.2017.04.001
  3. Data on File 1, Akebia Therapeutics, Inc.
  4. Umanath K, Sika M, Niecestro R, et al; 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. doi:10.1111/j.1542-4758.2012.00711.x