sucroferric oxyhydroxide 500 MG Chewable Tablet

INDICATIONS AND USAGE Velphoro is indicated for the control of serum phosphorus levels in adults and pediatric patients 9 years of age and older with chronic kidney disease (CKD) on dialysis. Velphoro 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. ( 1 )

DOSAGE AND ADMINISTRATION Chew or crush Velphoro tablets, do not swallow whole. ( 2.2 ) The recommended starting dose for adults and pediatric patients 12 years of age and older is one 500 mg tablet three times daily with meals. ( 2.1 ) The recommended starting dose for pediatric patients 9 to <12 years of age is one 500 mg tablet two times daily with meals. ( 2.1 ) Adjust dosage by one 500 mg tablet per day as needed until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. Titrate as often as weekly. ( 2.1 ) 2.1 General Dosing Information The recommended starting dose of Velphoro in adults and pediatric patients 12 years of age and older is one 500 mg tablet three times daily with meals. The recommended starting dose of Velphoro in pediatric patients 9 to <12 years of age is one 500 mg tablet two times daily with meals. Monitor serum phosphorus levels and titrate the dose of Velphoro in decrements or increments of one 500 mg tablet per day as needed until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. Titrate as often as weekly. If the recommended daily dose cannot be divided equally among meals, administer the larger dose with the largest meal of the day. In clinical studies, on average, adult patients and pediatric patients 12 years of age and older required 1,500 mg to 2,000 mg (3 to 4 tablets) a day to control serum phosphorus levels; pediatric patients 9 to <12 years of age required on average 1,500 mg (3 tablets) to control serum phosphorus levels. Daily doses as high as 3,000 mg per day have been studied in adults and pediatric patients 9 years of age and older. 2.2 Administration Velphoro chewable tablets should be chewed or crushed. Do not swallow whole. Velphoro chewable tablets must be administered with meals. If one or more doses of Velphoro are missed, the medication should be resumed with the next food intake.

WARNINGS AND PRECAUTIONS Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, history of recent major gastrointestinal 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. ( 5.1 ) 5.1 Monitoring in Patients with Gastrointestinal Disorders or Iron Accumulation Disorders Each chewable tablet contains 500 mg iron (equivalent to 2,500 mg sucroferric oxyhydroxide) [see Clinical Pharmacology (12.3) ] . 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.

CONTRAINDICATIONS None. None ( 4 )

Mechanism of Action In the aqueous environment of the GI tract, phosphate binding takes place by ligand exchange between hydroxyl groups and/or water in sucroferric oxyhydroxide and the phosphate in the diet. The bound phosphate is eliminated with feces. Both serum phosphorus levels and calcium-phosphorus product levels are reduced as a consequence of the reduced dietary phosphate absorption.