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Velphoro

Velphoro Recall

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Manufacturer Warnings

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Uses

Velphoro (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

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History

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Other Information

Velphoro chewable tablets are brown, circular, bi-planar, and are embossed with “PA 500” on 1 side. Each tablet of Velphoro contains 500 mg iron (in 2,500 mg sucroferric oxyhydroxide). The Velphoro drug substance is a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. The active moiety, polynuclear iron(III)-oxyhydroxide, is practically insoluble and cannot be absorbed. The inactive ingredients are woodberry flavor, neohesperidin dihydrochalcone, magnesium stearate, and silica (colloidal, anhydrous).

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Velphoro Manufacturers

  • Fresenius Medical Care North America
    Velphoro | Fresenius Medical Care North America
    No Recall

    Velphoro | Fresenius Medical Care North America

    Velphoro | Fresenius Medical Care North America

    Velphoro tablets must be chewed and not swallowed whole. To aid with chewing and swallowing, the tablets may be crushed.

    Starting Dose

    The recommended starting dose of Velphoro is 3 tablets (1,500 mg) per day, administered as 1 tablet (500 mg) 3 times daily with meals.

    Titration and Maintenance

    Monitor serum phosphorus levels and titrate the dose of Velphoro 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.

    Based on clinical studies, on average patients required 3 to 4 tablets (1,500 mg to 2,000 mg) a day to control serum phosphorus levels.

    The highest daily dose studied in a Phase 3 clinical trial in ESRD patients was 6 tablets (3,000 mg) per day.

    Administration

    Velphoro 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 Velphoro are missed, the medication should be resumed with the next meal. Do not attempt to replace a missed dose.

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