Velphoro sustained control with 3-4 tablets/day*

Reduction in serum phosphorus2-4
Weeks 0-24
Weeks 28-52
3.1 tablets/day
  • Effective in adults (≥18 years) regardless of age, gender, race, or dialysis modality (peritoneal or hemodialysis)1
  • 86% of patients remained adherent at 1 year in the long-term clinical study4
Give patients flexible administration options
 

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Give patients flexible administration options
 

learn more >

 

*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; 2014. 2. Data on file. Fresenius Medical Care North America, Waltham, MA. 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. 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. 

INDICATION
 

Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

IMPORTANT SAFETY INFORMATION
 

  • Velphoro must be administered with meals. Velphoro tablets must be chewed and not swallowed whole. To aid with chewing and swallowing, the tablets may be crushed.
  • 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. Take doxycycline at least 1 hour before Velphoro. Velphoro should not be prescribed with oral levothyroxine.

For additional important safety information, please see the full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America 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