Sucroferric Oxyhydroxide

Hyperphosphatemia in Chronic Kidney Disease Patient.

Sucroferric Oxyhydroxide is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. In the aqueous environment of the Gl 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.

Sucroferric Oxyhydroxide tablets should be chewed or crushed. Do not swallow whole. The recommended starting dose of Dephos is 3 tablets (1,500 mg) per day, administered as 1 tablet (500 mg) 3 times daily with meals. Monitor serum phosphorus levels and titrate the dose of Sucroferric Oxyhydroxide in decrements or increments of 500 mg (1 tablet) per day as needed until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. Titrate as often as weekly. Sucroferric Oxyhydroxide must be administered with meals. To maximize the dietary phosphate binding, distribute the total daily dose among meals. No additional fluid above the amount usually taken by the patient is required. If one or more doses of DephosrM are missed, the medication should be resumed with the next meal. Do not attempt to replace a missed dose.

Pediatric use: The safety and efficacy of Sucroferric Oxyhydroxide have not been established in pediatric patients.

• Sucroferric Oxyhydroxide can be administered concomitantly with oral calcitriol, ciprofloxacin, digoxin, enalapril, furosemide, HMG-CoA reductase inhibitors, hydrochlorothiazide, losartan, metoprolol, nifedipine, omeprazole, quinidine and warfarin.
• Take acetylsalicylic acid, cephalexin and doxycycline at least 1 hour before Sucroferric Oxyhydroxide.
• Take levothyroxine at least 4 hours before Sucroferric Oxyhydroxide.
• For oral medications not listed above where a reduction of bioavailability would be clinically significant consider separation of the timing of administration. Consider monitoring clinical responses or blood levels of the concomitant medication.

The most common adverse drug reactions to Sucroferric Oxyhydroxide chewable tablets in hemodialysis patients included discolored feces (12%) and diarrhea (6%).

Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 16 and 4 times, respectively, the human maximum recommended clinical dose on a body weight basis, and have not revealed evidence of impaired fertility or harm to the fetus due to Sucroferric Oxyhydroxide. However, Sucroferric Oxyhydroxide at a dose up to 16 times the maximum clinical dose was associated with an increase in post-implantation loss in pregnant rats. Animal reproduction studies are not always predictive of
human response. There are no adequate and well-controlled studies in pregnant women. Since the absorption of iron from Sucroferric Oxyhydroxide is minimal excretion of Sucroferric Oxyhydroxide in breast milk is unlikely.

Monitoring in Patients with Gastrointestinal Disorders or Iron Accumulation Disorders: Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal (Gl) surgery, or with a history of hemochromatosis or other diseases with iron accumulation have not been included in clinical studies with Sucroferric Oxyhydroxide. Monitor effect and iron homeostasis in such patients.

There are no data available from clinical trials on overdose with Sucroferric Oxyhydroxide.

Do not store above 25° C temperature. Keep away from light and wet place. Keep out of reach of children.