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 patients | AURYXIA N=557 |
|---|---|
| Diarrhea | 21% |
| Discolored feces | 19% |
| Nausea | 11% |
| Constipation | 8% |
| Vomiting | 7% |
| Cough | 6% |
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
Safety and tolerability profile evaluated in a 52-week trial1
41.9% of patients on AURYXIA experienced an SAE compared to 49.7% on Active Control5
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 class3,5 | AURYXIA N=289 | ACTIVE CONTROL N=149 |
|---|---|---|
| Gastrointestinal disorders | 7.6% | 12.8% |
| Cardiac disorders | 7.6% | 11.4% |
| Infection and infestations | 13.8% | 19.5% |
SAE=serious adverse event; Active Control=sevelamer carbonate and/or calcium acetate.
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 56.6
See trial design
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Trial design1,8
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.
CKD=chronic kidney disease; TSAT=transferrin saturation; Active Control=sevelamer carbonate and/or calcium acetate.