1) ADVERSE EFFECTS: Discoloration (black) of stool and diarrhea are common adverse events associated with sucroferric oxyhydroxide.

1) OVERDOSE: There are no reports of overdose with this agent. Absorption of iron from sucroferric oxyhydroxide is low and the risk of severe systemic effects of iron toxicity is minimal.
2) MILD TO MODERATE TOXICITY: Gastrointestinal events are likely to occur. Nausea and diarrhea can develop.
3) SEVERE TOXICITY: Severe events are not anticipated following overdose. Hypophosphatemia can develop.

1) Treatment is symptomatic and supportive. Significant toxicity is not anticipated. Administer antidiarrheal as needed for persistent diarrhea symptoms. Obtain a baseline phosphate level; repeat as indicated. Hypophosphatemia can develop.

1) Severe toxicity is not anticipated. Because the agent is minimally absorbed, significant iron toxicity is not anticipated. Obtain an iron level as indicated. Severe hypophosphatemia (serum phosphate concentration of less than 1 mg/dL over 2 or more days) can produce rhabdomyolysis, respiratory failure, acute hemolytic anemia and dysrhythmias. Replace phosphorus as indicated.

1) PREHOSPITAL: Gastric decontamination is not anticipated to be necessary due to minimal absorption.
2) HOSPITAL: Gastric decontamination is not anticipated to be necessary due to minimal absorption. Activated charcoal may be indicated if coingestants are suspected and the airway is protected.

1) Airway management is unlikely to be necessary.

1) SUMMARY: Hypophosphatemia may develop following overdose; monitor serum phosphate levels following overdose. Most patients with hypophosphatemia are usually asymptomatic; discontinue sucroferric oxyhydroxide therapy. Severe hypophosphatemia can produce rhabdomyolysis, respiratory failure, acute hemolytic anemia and dysrhythmias.
2) ORAL THERAPY: Moderate hypophosphatemia can be treated with oral phosphate supplementation. DOSE: Sodium phosphate or potassium phosphate tablets at 2.5 to 3.5 g daily (8 to 110 mmol) divided in 2 to 3 doses.
3) PARENTERAL THERAPY: Parenteral therapy is recommended for severe cases in patients with either symptomatic hypophosphatemia or an absolute serum phosphorus level less than 1 mg/dL or 0.32 mmol/L. DOSE: Doses up to 45 mmol and infusion rates up to 20 mmol per hour have been suggested as safe. Sodium phosphate is preferred over potassium phosphate to prevent hyperkalemia in patients at risk for this condition. Monitor serum phosphorus levels every 6 hours. IV therapy should be switched to oral supplementation once the phosphorus level exceeds 1 mg/dL.
4) ADVERSE EFFECTS: Large doses and/or rapid administration of parenteral phosphorus can produce hypocalcemia and resultant complications including tetany, hypotension, renal failure and potentially fatal arrhythmias, as well as hyperphosphatemia and hypomagnesemia.

1) Based on minimal absorption, enhanced elimination is unlikely to be effective.

1) Black stools are likely to develop with normal use of sucroferric oxyhydroxide; however, it may mask possible GI bleeding.

1) Polynuclear iron (III)-oxyhydroxide, the active moiety of sucroferric oxyhydroxide, is virtually insoluble and thus, not absorbed. Sucroferric oxyhydroxide reduces serum phosphorus and calcium-phosphorus product levels via a ligand-exchange process in the aqueous environment of the gastrointestinal tract in which dietary phosphate is exchanged for hydroxyl groups and/or water in sucroferric oxyhydroxide. The bound phosphate is thus eliminated in the feces, resulting in decreased dietary phosphate absorption. Tablets should be chewed or may be crushed to facilitate administration. Do NOT swallow whole.

1) HOME CRITERIA: Asymptomatic adults with an inadvertent ingestion of 1 to 2 extra doses can be monitored at home. An asymptomatic child with an inadvertent ingestion (1 tablet) can be monitored at home with adult supervision.
2) OBSERVATION CRITERIA: Patients that are symptomatic or had a deliberate ingestion should be referred to a healthcare facility for evaluation and treatment.
3) ADMISSION CRITERIA: Patients that develop persistent signs or symptoms of hypophosphatemia or other toxicity should be admitted.
4) CONSULT CRITERIA: Consult a medical toxicologist or poison center for patients with severe toxicity or in whom the diagnosis is unclear.

1) WITH THERAPEUTIC USE

1) WITH THERAPEUTIC USE

1) WITH THERAPEUTIC USE

1) Sucroferric oxyhydroxide is classified as pregnancy category B (Prod Info VELPHORO(R) oral chewable tablets, 2013).

1) LACK OF EFFECT

1) LACK OF INFORMATION: Lactation studies have not been conducted with sucroferric oxyhydroxide. Excretion of sucroferric oxyhydroxide in breast milk is unlikely as the absorption of iron from sucroferric oxyhydroxide is minimal (Prod Info VELPHORO(R) oral chewable tablets, 2013).

1) During animal reproduction studies, administration of sucroferric oxyhydroxide up to 16 times and 4 times the human maximum recommended dose in rats and rabbits, respectively, showed no evidence of impaired fertility or fetal harm (Prod Info VELPHORO(R) oral chewable tablets, 2013).

A) Patients that develop persistent signs or symptoms of hypophosphatemia or other toxicity should be admitted.

A) Asymptomatic adults with an inadvertent ingestion of 1 to 2 extra doses can be monitored at home. An asymptomatic child with an inadvertent ingestion (1 tablet) can be monitored at home with adult supervision.

A) Consult a medical toxicologist or poison center for patients with severe toxicity or in whom the diagnosis is unclear.

A) Patients that are symptomatic or had a deliberate ingestion should be referred to a healthcare facility for evaluation and treatment.

1) CHARCOAL ADMINISTRATION
2) CHARCOAL DOSE

1) Treatment is symptomatic and supportive. Significant toxicity is not anticipated. Administer antidiarrheal as needed for persistent diarrhea. Obtain a baseline phosphate level; repeat as indicated. Hypophosphatemia can develop.
2) Severe toxicity is not anticipated. Because the agent is minimally absorbed, significant iron toxicity is not anticipated. Obtain an iron level as indicated. Severe hypophosphatemia (serum phosphate concentration of less than 1 mg/dL over 2 or more days) can produce rhabdomyolysis, respiratory failure, acute hemolytic anemia and dysrhythmias. Replace phosphorus as indicated.

1) Routine laboratory studies are unlikely to be necessary. Obtain a baseline phosphate level following a significant exposure; repeat as indicated.

1) SUMMARY: Hypophosphatemia may develop following overdose; monitor serum phosphate levels following overdose (Prod Info VELPHORO(R) oral chewable tablets, 2013). Normal serum phosphate ranges from 2.5 to 4.5 mg/dL (0.81 to 1.45 mmol/l) in adults. Hypophosphatemia is defined as the following (Liamis et al, 2010):
2) Most patients with hypophosphatemia are usually asymptomatic and the only treatment required is discontinuation of the underlying cause (Liamis et al, 2010).
3) ADVERSE EFFECTS: Potential symptoms with severe hypophosphatemia are impaired oxygen delivery to the tissues and muscle weakness. A retrospective study found severe hypophosphatemia to be associated with a 4-fold increase in mortality (Rippe et al, 1996). Serum phosphorus concentrations of less than 1 mg/dL for 2 or more days can result in severe clinical events including rhabdomyolysis, respiratory failure, acute hemolytic anemia and dysrhythmias (Liamis et al, 2010).
4) ORAL THERAPY: Moderate hypophosphatemia can be treated with oral phosphate supplementation. In general, supplementation is 3 times the normal daily intake. DOSE: Sodium phosphate or potassium phosphate tablets at 2.5 to 3.5 g daily (8 to 110 mmol) divided in 2 to 3 doses (Liamis et al, 2010; Geerse et al, 2010). An adequate vitamin D concentration is needed for intestinal absorption of phosphate (Geerse et al, 2010); obtain a vitamin D level as indicated and supplement as needed.
5) PARENTERAL THERAPY: Parenteral therapy is recommended for severe cases in patients with either symptomatic hypophosphatemia or an absolute serum phosphorus level less than 1 mg/dL or 0.32 mmol/L. Intravenous phosphorous replacement may precipitate serum calcium causing hypocalcemia (Rippe et al, 1996; Geerse et al, 2010). Obtain serum phosphorus concentrations every 6 hours during parenteral therapy because repletion can be unpredictable (Liamis et al, 2010). DOSE: Replacement of phosphorus with doses up to 45 mmol and infusion rates up to 20 mmol per hour have been suggested (Geerse et al, 2010).
6) MONITORING: Therapy should be continued until the serum phosphorus exceeds 1 mg/dL, then therapy should be changed to oral phosphorus supplementation to avoid adverse effects (Liamis et al, 2010). Large doses of parenteral therapy can produce hypocalcemia with resultant tetany, hypotension, renal failure and potentially fatal arrhythmias, as well as hyperphosphatemia and hypomagnesemia (Geerse et al, 2010). Monitor phosphate, calcium and magnesium and vital signs during parenteral therapy (Liamis et al, 2010).
7) PREFERRED THERAPY: Sodium phosphate is preferred over potassium phosphate in patients at risk to develop hyperkalemia (Geerse et al, 2010).

1) During clinical studies, the average dose was 3 to 4 tablets (1500 to 2000 mg) daily to control serum phosphorus levels. The highest dosage used in Phase 3 trials in ESRD patients was 6 tablets (3000 mg) per day (Prod Info VELPHORO(R) oral chewable tablets, 2013).
2) Take tablets with meals and chew thoroughly. Tablets may be crushed to facilitate administration. Do NOT swallow whole. Divide the total daily dose across the meals of the day (Prod Info VELPHORO(R) oral chewable tablets, 2013).