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Sucroferric Oxyhydroxide

Generic name: sucroferric oxyhydroxide systemic

Brand names: Velphoro

Dosage Forms

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

Tablet Chewable, Oral:

Velphoro: 500 mg [berry flavor]

Pharmacology

Mechanism of Action

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.

Pharmacokinetics/Pharmacodynamics

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 US manufacturer's labeling.

Canadian labeling: Hypersensitivity to sucroferric oxyhydroxide or any component of the formulation; hemochromatosis or other iron accumulation disorders.

Dosage and Administration

Dosing: Adult

Note: One tablet contains 2.5 g of sucroferric oxyhydroxide which is equivalent to 500 mg of iron.

Hyperphosphatemia: Oral: Initial: One tablet (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: 3 to 4 tablets (1.5 to 2 g iron/day); doses of up to 6 tablets (3 g iron/day) have been evaluated.

Missed dose: If a dose is missed, resume with next meal; do not replace a missed dose.

Dosing: Geriatric

Refer to adult dosing.

Administration

Tablets must be chewed or crushed; do not swallow whole. Must administer with meals. The total daily dose should be divided among meals.

Dietary Considerations

One tablet contains ~1.4 g of carbohydrates.

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

Aspirin: Sucroferric Oxyhydroxide may decrease the serum concentration of Aspirin. Management: Administer aspirin at least 1 hour before administration of sucroferric oxyhydroxide. Consider therapy modification

Cephalexin: Sucroferric Oxyhydroxide may decrease the serum concentration of Cephalexin. Management: Administer cephalexin at least 1 hour before administration of sucroferric oxyhydroxide. Consider therapy modification

Levothyroxine: Sucroferric Oxyhydroxide may decrease the serum concentration of Levothyroxine. Management: Administer oral/enteral levothyroxine at least 4 hours before administration of sucroferric oxyhydroxide. No interaction is anticipated with parenteral levothyroxine administration. Consider therapy modification

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

Adverse Reactions

>10%: Gastrointestinal: Diarrhea (6% to 24%), darkening of stools (12% to 16%)

1% to 10%: Gastrointestinal: Nausea (10%)

<1%, postmarketing and/or case reports: Skin rash, dental discoloration

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.

Monitoring Parameters

Serum calcium, phosphorus, and parathyroid hormone (PTH): Frequency of measurement may be dependent upon the presence and magnitude of abnormalities, the rate of progression of chronic kidney disease (CKD), and the use of treatments for chronic kidney disease-mineral and bone disorder (CKD-MBD) (KDIGO 2017):

CKD stage G3a to G3b: Serum calcium and phosphate: Every 6 to 12 months; PTH: Frequency based on baseline level and progression of CKD

CKD stage G4: Serum calcium and phosphate: Every 3 to 6 months; PTH: Every 6 to 12 months

CKD stage G5 and G5D: Serum calcium and phosphate: Every 1 to 3 months; PTH: Every 3 to 6 months

Pregnancy

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

What is this drug used for?

  • It is used to lower high phosphate levels.

Frequently reported side effects of this drug

  • Dark stools

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

  • Severe nausea
  • Severe vomiting
  • Severe abdominal pain
  • Severe diarrhea
  • Signs of a significant reaction like 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. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated January 25, 2020.