Dephos500 mg

Dephos is an iron-based, calcium-free phosphate binder with the following approved and guideline-supported uses:

Established / FDA-Approved Use

• Control of serum phosphorus (hyperphosphatemia) in adults with chronic kidney disease (CKD) who are on dialysis (hemodialysis or peritoneal dialysis), as part of an overall management plan that also includes dietary phosphate restriction.
• Control of serum phosphorus in pediatric patients 9 years of age and older with CKD on dialysis.

Not Established / Not Recommended

• Dephos has not been studied and is not recommended for hyperphosphatemia in patients with CKD who are not yet on dialysis.
• Use in children younger than 9 years has not been established.

Dephos is intended for chronic, ongoing use alongside routine dialysis care and periodic laboratory monitoring, not as a stand-alone or short-course treatment.

Each chewable tablet contains Sucroferric Oxyhydroxide equivalent to 500 mg iron, formulated as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. Sucroferric Oxyhydroxide tablets are for oral use only and must be chewed or crushed before swallowing, never swallowed whole.

Dephos is a non-calcium, non-aluminum, iron-based phosphate-binding agent used in the management of hyperphosphatemia in patients with chronic kidney disease who require dialysis. It is supplied as a chewable tablet taken with meals.

Unlike calcium-based binders, Dephos does not add to a patient's calcium load, and unlike sevelamer it does not require large tablet or capsule burden for many patients, though tablets still need to be chewed or crushed rather than swallowed whole.

Dephos belongs to the class of phosphate-binding agents (iron-based, non-calcium phosphate binders), used in the management of chronic kidney disease–related mineral and bone disorder.

Mechanism of Action

Sucroferric Oxyhydroxide is a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. In the gastrointestinal tract, the iron-oxyhydroxide component binds dietary phosphate through ligand exchange, forming stable iron-phosphate complexes. Because phosphate is bound within the gut lumen rather than absorbed into the bloodstream, less phosphate is available for intestinal absorption, and the bound phosphate is eliminated in the feces.

Pharmacokinetics

Sucroferric Oxyhydroxide acts locally within the gastrointestinal tract. Systemic absorption of intact iron-oxyhydroxide is minimal; a small amount of iron may be absorbed and can modestly contribute to iron stores, but clinically significant systemic iron accumulation is not expected at recommended doses with normal iron homeostasis monitoring.

Dephos tablets must be chewed thoroughly or crushed — do not swallow whole. Take each dose with meals, as phosphate binding depends on the drug being present in the gut alongside dietary phosphate. If a dose is missed with a meal or snack, that dose should generally be skipped rather than doubled at the next meal; patients should follow their physician's specific instructions.

Dephos can reduce the gastrointestinal absorption of certain oral medications by binding to them in a manner similar to its phosphate-binding action. Clinically significant interactions include:

• Levothyroxine: Co-administration may reduce levothyroxine absorption and efficacy. Separate dosing (e.g., give levothyroxine well apart from Dephos) and monitor thyroid function after starting, stopping, or changing the dose of Dephos.
• Doxycycline and other drugs with narrow therapeutic windows or known reduced absorption with iron/phosphate binders: Consider separating administration times (commonly at least 1 hour before or several hours after Dephos) when a clinically important reduction in absorption or efficacy is a concern; consult a physician or pharmacist for specific drugs.

For any new oral medication, tell the prescriber or pharmacist that Dephos is being taken so that dosing timing can be reviewed and, if needed, adjusted.

The most common side effects of Dephos are gastrointestinal and generally mild to moderate:

• Discolored (dark) stool — very common (reported in roughly 1 in 8 patients); this is an expected, harmless cosmetic effect of the iron content and does not indicate gastrointestinal bleeding. New or unusual gastrointestinal symptoms (such as blood in stool, severe abdominal pain, or black tarry stool with other warning signs) should still be evaluated by a physician.
• Diarrhea — common, often improves with continued use or dose adjustment.
• Nausea, vomiting, constipation, and flatulence — reported less frequently.

Uncommon effects reported after marketing include tooth discoloration (typically reversible with dental hygiene) and skin rash. Patients should contact their physician if side effects are severe, persistent, or accompanied by other concerning symptoms.

Pregnancy: Data on the use of Dephos in pregnant women are limited. Dephos is minimally absorbed systemically, so significant fetal drug exposure is not expected; however, it should be used during pregnancy only if clearly needed, and management of hyperphosphatemia in a pregnant dialysis patient should be directed by a nephrologist, weighing potential benefit against any uncertain risk.

Lactation: Because systemic absorption of Dephos is minimal, exposure of a breastfed infant through milk is not expected to be clinically significant; nonetheless, a physician should be consulted before use while breastfeeding.

• Iron accumulation: Patients with disorders of iron overload (e.g., hemochromatosis) or receiving intravenous iron were not well studied with Dephos; monitor iron parameters periodically, particularly with prolonged use.
• Gastrointestinal conditions: Use with caution in patients with active peritonitis, significant hepatic disease, or a history of major gastrointestinal surgery, as these patients were excluded from pivotal trials.
• Discolored stool: Dark stool is an expected, harmless effect (see Side Effects) and should not be confused with gastrointestinal bleeding, though truly new or alarming gastrointestinal symptoms warrant evaluation.
• Drug spacing: Dephos may reduce absorption of certain oral medications (see Interactions); review the full medication list with a physician or pharmacist before starting.
• Administration technique: Tablets must be chewed or crushed, not swallowed whole, and taken with meals for adequate phosphate-binding effect.

Limited data are available on overdose with Dephos. Excessive intake could theoretically increase the risk of gastrointestinal side effects (such as diarrhea) or, with substantial excess, contribute to iron accumulation. If an overdose of Dephos is suspected, seek immediate medical attention or contact a poison control center / emergency services. Serum phosphorus and iron status should be monitored by a physician, and treatment should be supportive and directed by medical professionals; do not attempt specific home treatment for a suspected overdose.

Store at room temperature (below 30°C), away from light and moisture, in the original container. Keep out of reach of children.

Pediatric Use

Dephos is approved for children 9 years of age and older with CKD on dialysis, using a lower starting dose than adults (see Dosage and Administration). Safety and efficacy in children younger than 9 years have not been established.

Elderly

No overall differences in safety or effectiveness have been observed between elderly and younger adult patients; no dose adjustment is required based on age alone, though age-related organ function and concomitant medications should be considered.

Renal Impairment

Dephos is specifically indicated for patients with CKD who are already on dialysis; it has not been studied in CKD patients not on dialysis and is not recommended for that population.

Hepatic Impairment

Formal studies in hepatic impairment are limited; use with caution and closer monitoring in patients with significant liver disease, who were largely excluded from clinical trials.

Dephos is generally used long-term, for as long as the patient remains on dialysis and requires control of serum phosphorus levels. There is no fixed treatment duration; the dose is periodically reviewed and adjusted by the treating physician based on regular serum phosphorus monitoring, and treatment continues as part of ongoing chronic kidney disease and dialysis management.

Phosphate binder; iron-based (non-calcium, non-aluminum) phosphate-binding agent.

Sucroferric Oxyhydroxide releases its iron-oxyhydroxide component in the gastrointestinal tract, which binds dietary phosphate through ligand exchange to form insoluble iron-phosphate complexes. These complexes are not absorbed and are eliminated in the feces, thereby lowering the amount of phosphate available for absorption into the bloodstream and helping control serum phosphorus levels.

Dephos is approved for use in children 9 years of age and older with chronic kidney disease on dialysis. The recommended starting dose in children 9 to less than 12 years is one 500 mg tablet twice daily with meals; for children 12 years and older, adult dosing applies (one 500 mg tablet three times daily with meals, titrated as needed). Tablets must be chewed or crushed, not swallowed whole. Safety and efficacy of Dephos in children younger than 9 years have not been established, so it is not recommended for this age group.