Velphoro® Doubles Percentage of Patients Reaching Target Serum Phosphorous Levels in New Study Published in Journal of Renal Nutrition

VELPHORO® DOUBLES PERCENTAGE OF PATIENTS REACHING TARGET SERUM PHOSPHOROUS LEVELS | FMCNA

Fresenius Medical Care North America Examines Impact of Sucroferric Oxyhydroxide on Hemodialysis Patients with Kidney Failure; High Serum Phosphorous Levels Previously Linked to Increased Cardiovascular Disease

WALTHAM, MASS. – Jan. 28, 2019 – Fresenius Medical Care North America’s Renal Therapies Group announces the publication of a study in the Journal of Renal Nutrition examining the real-world effectiveness of sucroferric oxyhydroxide (Velphoro®) in managing serum phosphorous levels in hemodialysis patients with chronic kidney disease. High serum phosphorous levels, or hyperphospatemia, have previously been associated with increased cardiovascular disease and mortality.

A retrospective database analysis found that dialysis patients who switched from another phosphate binder to sucroferric oxyhydroxide doubled the likelihood of achieving target phosphorous levels while reducing their daily pill burden by half. Among 530 hemodialysis patients, the proportion achieving target serum phosphorus levels increased by more than 100 percent, from 17.7 percent to 36.0 percent, one year after switching to sucroferric oxyhydroxide therapy.

“Maintaining the recommended phosphorus level is important to the health of all patients with kidney failure,” said Dr. Robert Kossmann, Chief Medical Officer for Renal Therapies Group at Fresenius Medical Care North America. “This analysis suggests that switching patients from another phosphate binder to sucroferric oxyhydroxide is an effective means of achieving further phosphorus control, beyond following a low phosphate diet, while also reducing the pill burden to help patients adhere to the prescribed therapy.”

Oral phosphate binders, in combination with dialysis and dietary restriction, have been shown to effectively lower elevated phosphorus levels. The high pill burden of many phosphate binders, however, may contribute to decreased adherence leading to increased prevalence of hyperphosphatemia among patients undergoing maintenance hemodialysis therapy.

Sucroferric oxyhydroxide (Velphoro®) is a non-calcium, chewable, iron-based phosphate binder indicated for the treatment of hyperphosphatemia in dialysis patients. Velphoro® has a high phosphate-binding capacity with minimal iron absorption. 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 one-year retrospective analysis was extracted from the pharmacy service database of FreseniusRx and the Fresenius Kidney Care clinical data warehouse.

For more details of the study, read the manuscript online in the Journal of Renal Nutrition.

For more information about Velphoro®, visit velphoro.us.

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.

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, outpatient cardiac and vascular labs and urgent care centers, 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.