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INDICATION

Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in adult and pediatric patients 9 years of age and older with chronic kidney disease on dialysis.

IMPORTANT SAFETY INFORMATION

• Velphoro chewable tablets must be taken with meals. Velphoro should be chewed or crushed. Do not swallow whole. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and other supplements. Velphoro can interact with other medicines.
• Tell your healthcare provider if you have any of the following: peritonitis (an infection) during peritoneal dialysis, significant gastric or liver disorder, recent major gastrointestinal (GI) surgery, a history of hemochromatosis or other disease that results in iron buildup in the body. People with these conditions were not included in clinical studies with Velphoro, and your healthcare provider will monitor your iron levels while you are taking Velphoro.
• Velphoro can cause side effects. The most common side effects are discolored stool, diarrhea, and nausea. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. 
• Discolored (black) stool is considered normal if you are taking an oral medication that contains iron, like Velphoro. Discolored stool may mask gastrointestinal bleeding, which was not a side effect of Velphoro in clinical studies.
• Before taking Velphoro, tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.

Velphoro is available by prescription only. For additional Safety Information, please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care Customer Service at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.