Generic Name: sucroferric oxyhydroxide
Date of Approval: November 27, 2013
Company: Fresenius Medical Care Renal Pharma

Treatment for: Hyperphosphatemia of Renal Failure

FDA Approves Velphoro

The United States Food and Drug Administration (FDA) has approved Velphoro (sucroferric oxyhydroxide), an iron-based, calcium-free, chewable phosphate binder for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis.

What is Velphoro

Velphoro (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

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Hyperphosphatemia is an abnormal elevation of phosphorus levels in the blood, and it is a common and serious condition in CKD patients on dialysis. Most dialysis patients are treated with phosphate binders. The recommended starting dose of Velphoro is 3 tablets per day (1 tablet per meal) which provides a much lower pill burden than other currently available treatments.

Important Safety Information for Velphoro

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 ciprofloxacin, digoxin, enalapril, furosemide, HMG‑CoA reductase inhibitors, hydrochlorothiazide, losartan, metformin, metoprolol, nifedipine, omeprazole, quinidine and warfarin. Take alendronate and doxycycline at least 1 hour before Velphoro. Velphoro should not be prescribed with oral levothyroxine and oral vitamin D analogs.