Potency

 

Velphoro is 2.6x more powerful than 1 tablet of sevelamer*1

 

Phosphate binder equivalent dose (PBED) relative to Velphoro (%)*1

Bar graph shows that Velphoro is more potent than sevelamer, ferric citrate, lanthanum, or calcium-based binders.

 

*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

 

See the mechanism behind Velphoro potency

Phosphate is ingested and distributed throughout the body. Velphoro is highly selective for phosphorus in the pH range of the digestive tract (1.2 to 7.5).2 Phosphate from food binds to form phosphate-Velphoro complex, which is then excreted through the large intestine.3

More than 40% of patients are not at goal, indicating the ongoing challenge of phosphate management4-7

 

2/3 of patients have phosphorus levels beyond the KDIGO normal range4,5

Pie chart of DOPPS data shows that 2/3 of patients have phosphorus levels beyond the KDIGO normal range

DOPPS=Dialysis Outcomes and Practice Patterns Study

KDIGO=Kidney Disease: Improving Global Outcomes

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. Wilhelm M, Gaillard S, Viatcheslav R, Funk F. The iron-based phosphate binder PA21 has potent phosphate binding capacity and minimal iron release across a physiological pH range in vitro. Clin Nephrol. 2014;(81)4:251-258. 3. Velphoro® [package insert]. Waltham, MA: Fresenius Medical Care North America; 2024. 4. Dialysis Outcomes and Practice Patterns Study Program. DOPPS Practice Monitor. Serum phosphorus (most recent) categories. https://www.dopps.org/DPM/Files/phosphmgdl_c_overallTAB.htm. Accessed May 25, 2021. 5. Kidney Disease: Improving Global Outcomes. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Kidney Int. 2017;7(suppl 1):1-59. 6. Kidney Disease: Improving Global Outcomes. KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int. 2009;76(suppl 113):1-140. 7. National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(4 Suppl 3):S1-S201. 8. Dialysis Outcomes and Practice Patterns Study Program. DOPPS Practice Monitor. Phosphate binder use, by type. https://www.dopps.org/DPM/Files/pbgroup_c_overallTAB.htm. Accessed May 25, 2021. 9. Data on file. Fresenius Medical Care North America, Waltham, MA.

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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