Velphoro (Sucroferric Oxyhydroxide)

Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Velphoro is a phosphate binder supplied as chewable tablets for oral use, which are brown, circular, bi-planar, and are embossed with “PA 500” on 1 side. Each tablet of Velphoro contains 500 mg iron (in 2,500 mg sucroferric oxyhydroxide. The Velphoro drug substance is a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. One tablet is equivalent to approximately 1.4 g of carbohydrates (750 mg sucrose and 700 mg starches). The active moiety, polynuclear iron(III)-oxyhydroxide, is practically insoluble and cannot be absorbed. The inactive ingredients are berry flavor, neohesperidin dihydrochalcone, magnesium stearate, and silica (colloidal, anhydrous).

Ingredients

FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K) (IRON - UNII:E1UOL152H7)

Cautions

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.