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Sucroferric Oxyhydroxide

Pronunciation

(soo kroe FER ik ox ee hye DROX ide)

Index Terms

  • PA21
  • Polynuclear Iron (III)-Oxyhydroxide (pn-FeOOH)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Chewable, Oral:

Velphoro: 500 mg [berry flavor]

Brand Names: U.S.

  • Velphoro

Pharmacologic Category

  • Phosphate Binder

Pharmacology

Binds phosphate in the aqueous environment of the GI tract via ligand exchange between hydroxyl groups and/or water in sucroferric oxyhydroxide and dietary phosphate. Reduced dietary phosphate absorption results in reduced serum phosphorus levels and calcium-phosphorus product levels.

Absorption

Not systemically absorbed

Metabolism

Not metabolized

Excretion

Feces (as bound phosphate)

Use: Labeled Indications

Hyperphosphatemia: For control of serum phosphorus levels in patients with chronic kidney disease (CKD) receiving dialysis

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Hyperphosphatemia: Oral: Initial: 500 mg iron 3 times daily with meals. May titrate weekly (beginning 1 week after initiation) in increments or decrements of 500 mg iron per day as needed to appropriate serum phosphorus levels (≤5.5 mg/dL); usual maintenance dose: 1.5 to 2 g iron daily; doses of up to 3 g iron daily have been evaluated.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; however, not systemically absorbed or metabolized.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; however, not systemically absorbed or metabolized.

Administration

Tablets must be chewed; do not swallow whole. Tablets may be crushed to aid with chewing and swallowing. Must administer with meals. The total daily dose should be divided among meals.

Storage

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.

Drug Interactions

Levothyroxine: Sucroferric Oxyhydroxide may decrease the serum concentration of Levothyroxine. Management: Avoid the use of oral/enteral levothyroxine and sucroferric oxyhydroxide in combination. No interaction is anticipated with parenteral levothyroxine administration. Avoid combination

Tetracycline Derivatives: Sucroferric Oxyhydroxide may decrease the serum concentration of Tetracycline Derivatives. Management: Administer oral/enteral doxycycline at least 1 h before sucroferric oxyhydroxide. Specific dose separation guidelines for other tetracyclines are not presently available. No interaction is anticipated with parenteral administration of tetracyclines. Consider therapy modification

Adverse Reactions

>10%: Gastrointestinal: Diarrhea (4% to 24%), darkening of stools (12% to 16%)

1% to 10%: Gastrointestinal: Nausea (2% to 10%), dysgeusia (2%)

Warnings/Precautions

Disease-related concerns:

• Gastrointestinal disorders: Patients with significant gastrointestinal (GI) disorders or post major GI surgery were not included in clinical studies; monitor effect and iron homeostasis in these patients.

• Hemochromatosis: Use in patients with a history of hemochromatosis or other conditions associated with iron accumulation has not be studied; monitor effect and iron homeostasis in these patients.

• Hepatic disease: Use in patients with significant hepatic disorders has not been studied; monitor effect and iron homeostasis in these patients.

• Peritonitis: Use in patients with peritonitis during peritoneal dialysis has not been studied; monitor effect and iron homeostasis in these patients.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Tablet: Chew thoroughly to decrease risk of adverse GI effects; do not swallow whole.

Monitoring Parameters

Serum phosphorus levels

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in most animal reproduction studies. Maternal systemic absorption of sucroferric oxyhydroxide is low

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience black stools. Have patient report immediately to prescriber severe nausea, severe vomiting, severe abdominal pain, or severe diarrhea (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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