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*Based on an analysis of comparative clinical studies that roughly established an equivalent dose for phosphate binders relative to the phosphate binding capacity of calcium carbonate.1

†A retrospective analysis of deidentified clinical and prescription data from 818 hemodialysis patients extracted from the Fresenius Kidney Care clinical data warehouse and Fresenius pharmacy database. Clinical and laboratory parameters of 222 patients who continued Velphoro monotherapy for 24 months from baseline beginning between April 1, 2014, and April 1, 2015, were compared to 596 patients who discontinued Velphoro and were switched to alternate phosphate binders within 90 days of baseline. The decision to switch phosphate binders was made on a clinical basis and the reasons underlying this change were not available. Outcomes included achievement of target serum phosphorus of ≤5.5 mg/dL and phosphate binder pill burden.2

References: 1. Coyne DW, Larson DS, Delmez JA. Bone disease. In: Daugirdas JT, Blake PG, Ing TS, eds. Handbook of Dialysis. 5th ed. Wolters Kluwer Health; 2015:665-692. 2. Coyne DW, Ficociello LH, Parameswaran V, et al. Sucroferric oxyhydroxide in maintenance hemodialysis: a retrospective, comparative cohort study. Kidney Med. 2020;2(3):307-316. 3. Velphoro®  [package insert]. Waltham, MA: Fresenius Medical Care North America; 2020. 4. Data on file. Fresenius Medical Care North America. Waltham, MA. 5. Medicare.gov. Help with drug costs. https://www.medicare.gov/basics/costs/help/drug-costs. Accessed November 16, 2022.

 

 

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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 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 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

Fresenius Medical Care Renal Pharmaceuticals

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