Velphoro was well tolerated in the 52-week long-term study1,2

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

Diarrhea (24%)

The majority of diarrhea events were mild and transient, occurred soon after initiation of treatment, and resolved with continued treatment1
 

Discolored feces (16%)

Discolored feces is expected with an
iron-containing product1
 

Nausea (10%)

Incidents were reported during the first
6 months, but diminished over time2

Majority of GI AEs
were mild or
moderate in
severity1,2
  • No dose-dependent GI AEs were observed in a phase 2 dose-finding study1
  • No contraindications1

 

No clinically meaningful changes in iron parameters

  • No evidence of iron accumulation during 1 year of treatment1
  • No warning for iron overload1
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References:
1. Velphoro® [package insert]. Waltham, MA: Fresenius Medical Care North America; 2014. 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.

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