Hyperphosphatemia in patients with chronic kidney disease (CKD), especially those on dialysis.

Sucroferric Oxyhydroxide is a phosphate binder used to control serum phosphorus levels in patients with chronic kidney disease on dialysis. In the gastrointestinal tract, phosphate binding occurs through ligand exchange between hydroxyl groups and/or water in Sucroferric Oxyhydroxide and dietary phosphate. The bound phosphate is eliminated via feces. As a result, both serum phosphorus levels and calcium-phosphorus product levels are reduced due to decreased phosphate absorption from the diet.

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 used together with oral calcitriol, ciprofloxacin, digoxin, enalapril, furosemide, HMG-CoA reductase inhibitors, hydrochlorothiazide, losartan, metoprolol, nifedipine, omeprazole, quinidine, and warfarin without clinically significant interaction.
• Acetylsalicylic acid, cephalexin, and doxycycline should be taken at least 1 hour before Sucroferric Oxyhydroxide.
• Levothyroxine should be taken at least 4 hours before Sucroferric Oxyhydroxide.
• For other oral medications where reduced bioavailability may be clinically important, dosing times should be separated. Clinical response or drug blood levels should be monitored when necessary.

The most common adverse effects in hemodialysis patients include discolored feces (12%) and diarrhea (6%).

Pregnancy Category B. Animal studies in rats and rabbits (at doses up to 16 and 4 times the maximum human dose) did not show evidence of fertility impairment or fetal harm. However, a higher dose in rats was associated with increased post-implantation loss. There are no adequate studies in pregnant women. Because iron absorption from Sucroferric Oxyhydroxide is minimal, excretion into breast milk is considered unlikely.

Patients with gastrointestinal disorders, peritonitis during dialysis, significant gastric or hepatic disease, history of major GI surgery, hemochromatosis, or other iron overload conditions were not included in clinical trials. Therefore, caution is required in such patients. Iron status should be monitored regularly.

No clinical trial data are available regarding overdose with Sucroferric Oxyhydroxide.

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