FDA approved Velphoro (sucroferric oxyhydroxide) for Serum Phosphorus Control in Dialysis PatientsFDA approved New Chewable Drug to Lower Phosphorus in Dialysis Patients

Velphoro is a phosphate binder. The label does not provide a detailed mechanism of action.

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 chewable tablets must be chewed or crushed; do not swallow whole. Administer with meals. 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. For pediatric patients 9 to <12 years of age, the starting dose is one 500 mg tablet two times daily with meals. Titrate the dose by one 500 mg tablet per day as needed until an acceptable serum phosphorus level is reached, with regular monitoring. Titrate as often as weekly. If the daily dose cannot be divided equally among meals, administer the larger dose with the largest meal. In clinical studies, adults and pediatric patients 12 years and older required on average 1,500 mg to 2,000 mg (3 to 4 tablets) daily; pediatric patients 9 to <12 years required on average 1,500 mg (3 tablets) daily. Doses up to 3,000 mg per day have been studied. If a dose is missed, resume with the next food intake.

In a fixed-dose study (Study-03A), 154 adult hemodialysis patients with hyperphosphatemia (serum phosphorus >5.5 mg/dL but <7.75 mg/dL) were randomized to Velphoro 250, 1,000, 1,500, 2,000, or 2,500 mg/day or sevelamer hydrochloride. Velphoro was efficacious (p≤0.016) for all doses except 250 mg/day. Mean changes in iron parameters and vitamins were generally not clinically meaningful. GI adverse event profile was similar to sevelamer, with no dose-dependent trend.

In a dose titration study (Study-05A), 1,055 adult dialysis patients with serum phosphorus ≥6 mg/dL were randomized to Velphoro (starting dose 1,000 mg/day) or sevelamer carbonate for 24 weeks. At Week 24, 93 hemodialysis patients with controlled phosphorus (<5.5 mg/dL) on Velphoro were re-randomized to continue their maintenance dose (1,000 to 3,000 mg/day) or a low-dose control (250 mg/day) for 3 weeks. The maintenance dose was statistically significantly superior in sustaining phosphorus lowering at Week 27 (p<0.001). Mean change from baseline to end of treatment was 0.3 mg/dL for maintenance vs 1.8 mg/dL for low dose.

The label does not list any contraindications or specific warnings in the provided text. Please consult the full prescribing information for complete safety information.

Velphoro is an oral phosphate binder indicated for adults and pediatric patients 9 years and older with CKD on dialysis. It is administered with meals and requires chewing or crushing. Clinical trials demonstrate efficacy in lowering serum phosphorus, with a GI tolerability profile similar to sevelamer. It provides an additional option for managing hyperphosphatemia in dialysis patients.