Velphoro Sucroferric Oxyhydroxide Chewable Tablets

1. Indications and Usage
Hyperphosphatemia in Chronic Kidney Disease (CKD):
Treatment of hyperphosphatemia in adult patients on dialysis (hemodialysis or peritoneal dialysis).
Note: Also indicated for CKD patients (stages 4–5) not on dialysis with serum phosphorus ≥ 5.5 mg/dL (≥ 1.78 mmol/L).
2. Dosage and Administration
Route of Administration:
Oral administration.
Recommended Dosage:
Initial Dose: 500 mg (1 tablet, corresponding to 150 mg Iron) three times daily with meals.
Titration: Dosage should be adjusted every 2–3 weeks based on serum phosphorus levels.
Maintenance Dose: Typically 1000 mg to 3000 mg per day, divided into three doses.
Maximum Dose: 3000 mg per day (6 tablets).
Critical Administration Instructions:
Chew or Crush: These are Chewable Tablets. They MUST be chewed thoroughly or crushedbefore swallowing. Do not swallow whole.
With Food: Must be taken with meals to effectively bind dietary phosphorus.
Flavor: The tablets have a chocolate-like flavor to improve palatability.
3. Mechanism of Action
Iron-Based Binding:
Sucroferric Oxyhydroxide contains a polynuclear iron (III)-hydroxide core stabilized by a carbohydrate shell (sucrose and starch).
Ligand Exchange:
In the acidic environment of the stomach, it binds to dietary phosphate via ligand exchange.
Therapeutic Result: It forms insoluble iron-phosphate complexes that are excreted in the feces, thereby reducing serum phosphorus levels.
Specificity: It is a non-calcium, non-aluminum binder.
4. Safety and Warnings
Gastrointestinal Obstruction:
Caution is advised in patients with severe gastrointestinal disorders (e.g., strictures).
Iron Accumulation:
A small amount of iron is absorbed systemically.
Action: Monitor iron status (Ferritin, Transferrin Saturation) periodically to avoid iron overload.
Contraindications:
Hypophosphatemia.
Hemochromatosis or other iron overload disorders.
Bowel obstruction.
5.Adverse Reactions
Most Common:
Fecal Discoloration: Darkening of the feces (black/dark brown) is very common and harmless.
Diarrhea: Occurs in a significant number of patients, usually mild and transient.
Nausea: Reported in approximately 10% of patients.
6.Drug Interactions
Absorption Interference:
May reduce the absorption of other concomitantly administered oral medications.
Action: Administer other oral drugs at least 1 hour before or 2 hours after Sucroferric Oxyhydroxide.
Specific Drugs:
Antacids: Avoid concomitant use with aluminum-containing antacids.
Fluoroquinolones/Thyroid Hormones: Separation of dosing is recommended.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Sucroferric Oxyhydroxide.
Appearance: Red-brown, round, film-coated chewable tablets (imprinted “PA500”).
Packaging: Blister packs (500 mg).
Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Protect from moisture.