Abstracts on Velphoro® Accepted for Presentation at the American Society of Nephrology Kidney Week

DATA DEMONSTRATES SWITCHING PATIENTS TO VELPHORO DOUBLED THE PERCENTAGE OF PATIENTS ACHIEVING SERUM PHOSPHORUS CONTROL

Waltham, Mass. Nov. 3, 2017 – Fresenius Medical Care Renal Therapies Group announced today that four abstracts on Velphoro® (sucroferric oxyhydroxide) have been accepted for presentation at the American Society of Nephrology (ASN) annual Kidney Week held Oct. 31-Nov. 5, 2017 in New Orleans.

The abstracts describe the real world outcomes in serum phosphorus control and a significant reduction in pill burden achieved in hemodialysis patients who switched to Velphoro as part of their routine clinical care.

Two abstracts focus on a two-year follow-up of patients and include sub-analyses based on the patients’ previous phosphate binder therapy. One abstract documents the changes in mineral bone disease markers in hyperphosphatemic patients who achieved target phosphorus ranges. The fourth abstract describes the change in nutritional markers among patients with low serum albumin who switched to Velphoro.

“Real world data demonstrates switching patients to Velphoro doubled the percentage of patients achieving serum phosphorus control. DOPPS Practice Monitor highlights up to 35 percent of patients are outside of their target phosphorus goal at any given time,” explained Mark Costanzo, president, Fresenius Medical Care Renal Therapies Group.

All four abstracts were accepted for poster presentations on Thursday, Nov. 2. All four are available online on the conference’s website: https://www.asn-online.org/education/kidneyweek/2017/program-search-abstract.aspx.

Poster Presentations

1. “Effectiveness of Sucroferric Oxyhydroxide (SO) in Lowering Serum Phosphorus (sP) in 4,925 Chronic Hemodialysis (HD) Patients Prescribed SO as part of routine care.”
   Daniel W. Coyne, Linda H. Ficociello, Vidhya Parameswaran, Norma J. Ofsthun, Claudy Mullon, Robert J. Kossmann, Stuart M. Sprague
   Session Title: 1201-PO01 Mineral Disease: Ca/Mg/PO4
   Poster Board #: TH-PO1031
2. “Two Year Follow Up on Chronic Hemodialysis (HD) Patients Prescribed Sucroferric Oxyhydroxide as Part of Routine Care”
   Stuart M. Sprague, Vidhya Parameswaran, Linda H. Ficociello, Norma J. Ofsthun, Claudy Mullon, Robert J. Kossmann, Daniel W. Coyne
   Session Title: 1201-PO01 Mineral Disease: Ca/Mg/PO4
   Poster Board #: TH-PO1030
3. “Serum Albumin and Serum Phosphorus among Hemodialysis Patients after Initiating Sucroferric Oxyhydroxide (SO)”
   Kamyar Kalantar-Zadeh, Linda H. Ficociello, Vidhya Parameswaran, Hasi Mondal, Nicolaos V. Athienites, Claudy Mullon, Robert J. Kossmann
   Session Title: 1201-PO01 Mineral Disease: Ca/Mg/PO4
   Poster Board #: TH-PO1033
4. “Changes in Mineral Bone Disease (MBD) Markers in Hemodialysis (HD) Patients Switched to Sucroferric Oxyhydroxide (SO).”
   Sandeep Shori, Vidhya Parameswaran, Linda H. Ficociello, Claudy Mullon, Robert J. Kossmann
   Session Title: 1201-PO01 Mineral Disease: Ca/Mg/PO4
   Poster Board #: TH-PO1032

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 disease 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 six 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 one hour before Velphoro. Velphoro should not be prescribed with oral levothyroxine.

For more information, please see full Prescribing Information, contact your Fresenius Medical Care North America representative or visit www.Velphoro.us/hcp.

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 health care 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.