sucroferric oxyhydroxide (Rx)

Brand and Other Names:Velphoro
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

chewable tablet

  • 500mg (amount of iron)
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Hyperphosphatemia

Indicated for control of serum phosphorus levels in patients with chronic kidney disease on hemodialysis

Initial: 500 mg PO TID with each meal

Titration and maintenance

  • Monitor serum phosphorus levels and titrate the dose in decrements or increments of 500 mg (ie, 1 tablet) per day as needed until an acceptable serum phosphorus level (≤5.5 mg/dL) is reached, with regular monitoring afterwards
  • Titration can be started as early as 1 week after treatment initiation and adjusted at weekly intervals thereafter if necessary
  • Based on clinical studies, on average patients required 3-4 tablets (1,500-2,000 mg/day)
  • The highest daily dose studied in a Phase 3 clinical trial in patients with ESRD was 6 tablets (3,000 mg/day)

Administration

Must be administered with meals (adsorbs dietary phosphate in the gut)

To maximize the dietary phosphate binding, the total daily dose should be divided across the meals of the day

Tablets must be chewed and not swallowed whole; to aid with chewing and swallowing, the tablets may be crushed

If 1 or more doses are missed, the medication should be resumed with the next meal; do not attempt to replace a missed dose

Safety and efficacy not established

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Interactions

Interaction Checker

and sucroferric oxyhydroxide

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Diarrhea (6-24%)

            Discolored feces (12-16%)

            1-10%

            Nausea (10%)

            Postmarketing Reports

            Tooth discoloration

            Rash

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            Warnings

            Contraindications

            None

            Cautions

            Monitor effect and iron homeostasis with patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal surgery, or with a history of hemochromatosis or other diseases with iron accumulation

            Do not prescribe with oral levothyroxine

            Do not administer alendronate or doxycycline at the same time; alendronate or doxycycline must be given at least 1 hr before sucroferric oxyhydroxide

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            Pregnancy & Lactation

            Pregnancy Category: b

            Lactation: Absorption of iron is minimal, and therefore excretion into to breast milk is unlikely

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Iron-based, calcium-free phosphate binder (stabilized polynuclear iron [III]-oxyhydroxide); when taken with meals, adsorbs dietary phosphate in the GI tract and prevents its uptake into the blood

            Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water in sucroferric oxyhydroxide and the phosphate in the diet; bound phosphate is eliminated with feces

            Pharmacokinetics

            Active moiety (polynuclear iron[III]-oxyhydroxide) is practically insoluble and therefore not absorbed and not metabolized

            The sucrose and starch components can be digested to glucose and fructose, and maltose and glucose, respectively; these compounds can be absorbed in the blood (1 tablet = 1.4 g of carbohydrates)

            Median iron update in patients with chronic kidney disease is 0.04% on Day 21 (based on 2,000 mg/day of sucroferric oxyhydroxide/day)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
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            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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