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The active ingredient in Velphoro is sucroferric oxyhydroxide, a mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches. Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the phosphate ions throughout the gastrointestinal tract. Serum phosphorus levels are reduced because of reduced dietary phosphate absorption.
Dose titration
Velphoro is available as 500mg chewable tablets and is initiated at a dose of 1 tablet three times a day with meals. The dose can be increased or decreased by 1 tablet daily until an acceptable serum phosphate level is reached. This is usually achieved with a dose of 3 or 4 tablets daily but the dose may be increased to a maximum of 6 tablets daily in divided doses if necessary.
Non-inferior to sevelamer
The efficacy and safety of sucroferric oxyhydroxide was compared with that of sevelamer in a pivotal randomised, open-label stage III clinical study. Investigators recruited patients receiving either haemodialysis or peritoneal dialysis who had a serum phosphorus level ≥1.94 mmol/L following a phosphate-binder washout period of 2–4 weeks. Participants were randomised to receive sucroferric oxyhydroxide 1–3g per day (n=707) or sevelamer 4.8–14.4g per day (n=348) for an 8-week dose titration, followed by 4 weeks of stable dosing, and then 12 weeks of maintenance treatment.
Serum phosphorus reductions at week 12 were −0.71 mmol/L for sucroferric oxyhydroxide and −0.79 mmol/L for sevelamer, demonstrating non-inferiority of, on average, three tablets of sucroferric oxyhydroxide vs eight of sevelamer.
Safety profile
The majority of the adverse drug reactions reported from trials were gastrointestinal disorders, with diarrhoea and dark stools being reported very commonly. The vast majority of these gastrointestinal disorders occurred early during treatment but lessened over time.
Further information: Fresenius Medical Care
