Dephos

Approved Indications:

• Hyperphosphatemia in Chronic Kidney Disease (CKD):
• Indicated as a phosphate binder to reduce serum phosphorus levels in adult patients with chronic kidney disease on dialysis (both hemodialysis and peritoneal dialysis).
• Used in patients with serum phosphorus levels ≥5.5 mg/dL when dietary phosphorus restriction alone is insufficient.

Off-label (Clinically Accepted) Uses:

• None widely accepted or recommended beyond labeled use at this time.

Adult Dosage:

• Initial Dose: 500 mg (1 chewable tablet) orally three times daily with meals.
• Titration: Adjust dose in 500 mg increments every 2–4 weeks based on serum phosphorus levels.
• Maintenance Dose Range: Typically 1,500 mg to 3,000 mg/day in divided doses with meals.
• Maximum Dose: Up to 3,000 mg/day (6 tablets) may be required in some patients.

Pediatric Use:

• Safety and efficacy in patients under 18 years of age have not been established.

Elderly Patients:

• No dose adjustment is required; monitor phosphate levels and tolerance.

Renal Impairment:

• Designed for patients with end-stage renal disease; no additional adjustment needed.

Hepatic Impairment:

• No specific dosage adjustments recommended; use with caution.

Administration Guidelines:

• Tablets must be chewed or crushed completely before swallowing; do not swallow whole.
• Must be taken with meals to effectively bind dietary phosphate.
• Avoid taking within 1 hour of other oral medications with narrow therapeutic index.

Sucroferric oxyhydroxide is a non-calcium, iron-based phosphate binder that acts locally within the gastrointestinal tract. It binds dietary phosphate in the stomach and small intestine through ligand exchange between hydroxyl and/or water groups on the iron and phosphate ions, forming insoluble iron-phosphate complexes. These complexes are not absorbed and are excreted in the feces. By reducing phosphate absorption from the diet, the drug lowers serum phosphorus levels in patients with impaired renal phosphate excretion.

• Absorption: Minimal systemic absorption; acts locally in the GI tract.
• Bioavailability: Negligible systemic iron exposure (<0.02% of dose absorbed).
• Distribution: Not systemically distributed; localized to GI lumen.
• Metabolism: Not metabolized; remains chemically unchanged in the GI tract.
• Elimination:
• Fecal Excretion: Majority of the drug and phosphate complexes are excreted in feces.
• Renal Excretion: Negligible due to minimal systemic absorption.
• Onset of Action: Reduction in serum phosphate typically observed within 1–2 weeks.
• Half-life: Not applicable due to negligible systemic absorption.

• Pregnancy:
• Classified as Pregnancy Category B (US FDA). Animal studies have not shown fetal harm, but adequate, well-controlled studies in pregnant women are lacking.
• Use during pregnancy only if clearly needed and benefit outweighs potential risk.
• Lactation:
• Unknown whether the drug or its metabolites are excreted in human milk.
• Due to minimal systemic absorption, exposure in breastfed infants is unlikely.
• Caution is advised; consider potential benefits vs. theoretical risks.

• Primary Class: Phosphate Binder
• Subclass: Non-calcium, Iron-based Phosphate Binder

• Known hypersensitivity to sucroferric oxyhydroxide or any of its excipients.
• Iron overload syndromes (e.g., hemochromatosis) — risk of exacerbating iron accumulation.
• Severe GI disorders, such as bowel obstruction or severe constipation.

• Iron Overload Risk: Although systemic absorption is minimal, monitor ferritin and transferrin saturation periodically, especially in patients receiving IV iron.
• Gastrointestinal Effects: Risk of diarrhea, discolored stools, and nausea; monitor patients with pre-existing GI conditions.
• Drug Absorption Interference: May affect absorption of co-administered oral drugs with narrow therapeutic ranges (e.g., levothyroxine, doxycycline); stagger administration times.
• Aluminum Content: Avoid use in patients on chronic aluminum-based phosphate binders due to potential additive toxicity.
• Monitoring Requirements:
• Serum phosphorus (every 2–4 weeks initially)
• Iron parameters (ferritin, TSAT)
• GI symptoms

Common (≥5%)

• Gastrointestinal:
• Diarrhea
• Discolored (dark) stools
• Nausea
• Flatulence
• Abdominal discomfort

Less Common or Rare:

• Constipation
• Vomiting
• Iron overload (rare; minimal systemic absorption)
• Hypophosphatemia if overdosed or not monitored properly

Serious Adverse Effects:

• GI bleeding (rare)
• Severe diarrhea leading to dehydration
• Allergic reactions (rash, pruritus)

Onset of GI side effects is usually within the first few weeks of therapy and may be dose-related.

• Oral Medications with Narrow Therapeutic Index:
• Examples: Levothyroxine, doxycycline, ciprofloxacin — absorption may be reduced; separate dosing by at least 1 hour.
• Iron Supplements:
• Avoid concurrent use with oral iron supplements to prevent iron overload.
• No significant CYP450 enzyme interactions, as the drug is not systemically absorbed and does not inhibit or induce major CYP enzymes.

No known food or alcohol interactions of clinical significance.

• No major FDA label changes or new indications as of the latest updates in 2024–2025.
• KDIGO 2024 Update: Continues to recommend non-calcium-based phosphate binders like sucroferric oxyhydroxide in dialysis-dependent CKD patients with persistent hyperphosphatemia, especially those with vascular calcification risks.
• Monitoring guidance refined in recent nephrology guidelines for iron parameters during long-term therapy.

• Temperature: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C–30°C (59°F–86°F).
• Humidity & Light: Protect from moisture and excessive heat; store in original blister pack until use.
• Handling Precautions: Do not swallow tablets whole; must be chewed or crushed.
• Refrigeration/Reconstitution: Not required.