Tolerability


GI adverse events were mild to moderate, and resolved without intervention1

Adverse events occurring in >5% of patients during the 52-week clinical study1,2:

  • Diarrhea (24%): The majority of diarrhea events were mild and transient, occurred early in treatment, and resolved with continued use1

Number of patients and week of first onset of diarrhea1,3,4

Over 1 year of treatment, first onset of diarrhea occurred for 6% of patients during the first week.
  • Discolored feces (16%): Discolored feces is expected with an iron-containing product1
  • Nausea (10%): Incidences were reported during the first 6 months, but diminished over time with continued use2

 

GI Tract

NO DOSE-DEPENDENT Gl adverse events1

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About half the incidence of constipation vs sevelamer: 3.8% vs 7.2%3

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The only phosphate binder with
NO CONTRAINDICATIONS1,5-9

Velphoro is selective, with few drug or metabolic interactions

  • Velphoro is a powerful, selective phosphate binder that doesn’t bind to vitamins A, D, E, K, or folic acid, as sevelamer does1,5

Patients taking Velphoro require no additional monitoring for iron management

  • The iron in Velphoro is minimally absorbed1
  • No additional monitoring of iron indices needed1
  • Velphoro has no contraindications, and does not contribute to iron overload syndrome1

*A 52-week, open-label, active-controlled, phase 3 study evaluated the safety and efficacy of Velphoro in lowering serum phosphorus levels in patients (N=1,054) with chronic kidney disease on hemodialysis or peritoneal dialysis. In the titration phase (first 24 weeks), patients were randomized to receive either Velphoro or sevelamer carbonate to establish the noninferiority of Velphoro to sevelamer carbonate in lowering serum phosphorus at 12 weeks (secondary endpoint). The following withdrawal phase (weeks 24 to 27, n=93) established the superiority of Velphoro with an effective maintenance dose over a placebo-like low dose (primary endpoint). During a final long-term maintenance phase (weeks 28-52, n=658), patients continued phosphate binder treatment according to their original randomization for the assessment of long-term efficacy, safety, and tolerability.1

References: 1. Velphoro® [package insert]. Waltham, MA: Fresenius Medical Care North America; 2024. 2. Floege J, Covic AC, Ketteler M, et al: on behalf of the Sucroferric Oxyhydroxide Study Group. Long‐term effects of the iron‐based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrol Dial Transplant. 2015;30(6):1037‐1046. 3. Floege J, Covic AC, Ketteler M, et al; on behalf of the PA21 Study Group. A phase III study of the efficacy and safety of a novel iron‐based phosphate binder in dialysis patients. Kidney Int. 2014;86(3):638-647. 4. Data on file. Fresenius Medical Care North America, Waltham, MA. 5. Renvela [package insert]. Cambridge, MA: Genzyme Corporation, a Sanofi Company; 2023. 6. PhosLo [package insert]. Waltham, MA: Fresenius Medical Care North America; 2011. 7. Auryxia [package insert]. Cambridge, MA: Akebia Therapeutics, Inc.; 2024. 8. Fosrenol [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; 2024. 9. Renagel [package insert]. Cambridge, MA: Genzyme Corporation; 2021.

INDICATION

Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in adult and pediatric patients 9 years of age and older with chronic kidney disease on dialysis.

IMPORTANT SAFETY INFORMATION

  • Velphoro chewable tablets must be administered with meals. Velphoro should be chewed or crushed. Do not swallow whole.
  • Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal (GI) surgery, or with a history of hemochromatosis or other diseases with iron accumulation have not been included in clinical studies with Velphoro. Monitor effect and iron homeostasis in such patients.
  • In a parallel design, fixed-dose study of 6 weeks duration, the most common adverse drug reactions to Velphoro chewable tablets in hemodialysis patients included discolored feces (12%) and diarrhea (6%).
  • Velphoro can be administered concomitantly with oral calcitriol, ciprofloxacin, digoxin, enalapril, furosemide, HMG-CoA reductase inhibitors, hydrochlorothiazide, losartan, metoprolol, nifedipine, omeprazole, quinidine and warfarin. For oral medications where a reduction of bioavailability would be clinically significant consider separating of the timing of administration. Consider monitoring clinical responses or blood levels of the concomitant medications.

Velphoro is available by prescription only. For additional Safety Information, please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care Customer Service at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This information is intended for use by US healthcare professionals only.

Distributed by:
Fresenius Medical Care North America
Waltham, MA 02451

Fresenius Medical Care Renal Pharmaceuticals

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