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Sucroferric Oxyhydroxide

Medically reviewed by Drugs.com. Last updated on May 18, 2020.

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 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.

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.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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. Consider therapy modification

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>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.

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 Considerations

Sucroferric oxyhydroxide is not systemically absorbed and not expected to result in fetal exposure.

Patient Education

What is this drug used for?

• It is used to lower high phosphate levels.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nausea

• Diarrhea

• Dark stools

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.