New Retrospective Two-Year Study Demonstrates Velphoro® Effectiveness

New Two-Year Study Demonstrates Velphoro® Effectiveness | FMCNA

Study Examines Impact of Long-Term Use of Sucroferric Oxyhydroxide Compared to Patients Who Switched to Other Binders

WALTHAM, MASS. – March 31, 2020 – A new retrospective data analysis published in Kidney Medicine shows that a higher percentage of hemodialysis patients prescribed Velphoro® (sucroferric oxyhydroxide chewable tablets) achieved target serum phosphorous levels of ≤5.5 mg/dL compared to those patients who switched from Velphoro to another phosphate binder.

The analysis examined 222 patients who remained on Velphoro maintanence therapy for two years, and compared those patients to a comparator group of 596 patients who discontinued the drug within 90 days and switched to other phosphate binders.

A higher percentage of patients who remained on Velphoro achieved target serum phosphorus levels with about half the number of phosphate binder pills per day. A total of 45 percent of patients using Velphoro achieved target levels with that lower pill burden compared to 31.9 percent of patients who switched to other binders with no change in pill burden.

“This novel analysis is giving us more evidence that the use of Velphoro has several benefits for our dialysis patients by increasing the number of patients that achieve target serum phosphate levels and lowering the pill burden compared to other prescribed phosphate binders,” said Dr. Michael Anger, Chief Medical Officer for Renal Therapies Group at Fresenius Medical Care North America.

“Previous real world studies have shown similar results with Velphoro, but lacked a control group,” said first study author Dr. Daniel Coyne, Professor of Medicine, Washington University School of Medicine St Louis. “This two-year analysis addresses that problem, and shows marked improvements with Velphoro that are not achieved using other phosphorus binders.”

Velphoro is a non-calcium, chewable, iron-based phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Velphoro has a high phosphate-binding capacity relative to equivalent doses of other commonly prescribed phosphate binders and the iron in Velphoro is minimally absorbed. The recommended starting dose of Velphoro is three tablets (1,500 mg) per day, administered as one tablet (500 mg) three times daily with meals.

Clinical data for the two-year retrospective analysis were extracted from a pharmacy service database for FreseniusRx, and the Fresenius Kidney Care clinical data warehouse.

For more details of the study, read the manuscript online in Kidney Medicine.

For more information about Velphoro, visit velphorohcp.com

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.

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.

About Fresenius Medical Care North America

Fresenius Medical Care North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities and outpatient cardiac and vascular labs, Fresenius Medical Care North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world’s largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products, and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com.

Media Contact:
Fresenius Medical Care North America
Brad Puffer
Corporate Communications
brad.puffer@fmc-na.com
(781) 699-3331