Company: Vifor Pharma UK Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Iron (as sucroferric oxyhydroxide) 500mg.
Description: Brown, circular tablets marked PA500.
Presentation: 90, €179.78.
Indications: Control of serum phosphorus levels in chronic kidney disease patients on haemodialysis or peritoneal dialysis. Should be used as part of a multiple therapeutic approach (could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics).
Pharmacology: Sucroferric oxyhydroxide is also known as a mixture of polynuclear iron(III)-oxyhydroxide (pn‑FeOOH), sucrose and starches. Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the phosphate ions throughout the physiological pH range of the gastrointestinal tract. Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption.
Dosage: Adult: Chew or crush tablets. Initially 3 tablets daily with meals. Up or down titrate in increments of 1 tablet per day every 2-4 weeks until acceptable serum phosphorus level reached (regularly monitor thereafter). Maximum 6 tablets per day. Elderly: As per adults. Children: Under 18 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Haemochromatosis and any other iron accumulation disorders.
Special precautions: Recent peritonitis (within 3 months), significant gastric/ hepatic disorders or major gastrointestinal surgery; assess risk/benefit. May cause discoloured (black) stool (may mask gastrointestinal bleeding). Contains sucrose, starches. Pregnancy (only if clearly needed), lactation; assess risk/benefit.
Drug interactions: Drugs with a narrow therapeutic window. Drugs interacting with iron (e.g. alendronate, doxycycline). Cephalexin, levothyroxine, doxercalciferol, paricalcitol (during 1 hour before or 2 hours after).
Adverse drug reactions: Gastrointestinal disorders, abnormal product taste.
Full prescribing information and references available from Vifor Pharma UK Ltd. Telephone: (0044) 1276 853600.