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Sucroferric oxyhydroxide: Drug information

Sucroferric oxyhydroxide: Drug information
(For additional information see "Sucroferric oxyhydroxide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Velphoro
Brand Names: Canada
  • Velphoro
Pharmacologic Category
  • Phosphate Binder
Dosing: Adult

Note: Each 2,500 mg sucroferric oxyhydroxide tablet contains 500 mg of iron.

Hyperphosphatemia in chronic kidney disease, treatment

Hyperphosphatemia in chronic kidney disease (dialysis-dependent), treatment:

Note: Use in combination with dietary phosphate restriction (Ref). The majority of iron from sucroferric oxyhydroxide is not systemically absorbed, although small increases in transferrin saturation and ferritin have been observed (Ref).

Oral: Initial: 1 tablet (500 mg iron) 3 times daily with meals.

Dosage adjustment: Increase or decrease dose by 1 tablet (500 mg iron) per day at ≥1-week intervals as needed to obtain targeted serum phosphorus concentrations; usual maintenance dose: 3 to 4 tablets (1,500 to 2,000 mg iron) per day; maximum dose: 6 tablets (3,000 mg iron) per day.

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: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

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

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.

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.

Dosage Forms: US

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

Tablet Chewable, Oral:

Velphoro: Iron 500 mg (sucroferric oxyhydroxide 2.5 g) [berry flavor]

Generic Equivalent Available: US

No

Pricing: US

Chewable (Velphoro Oral)

500 mg (per each): $21.44

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Tablet Chewable, Oral:

Velphoro: Iron 500 mg (sucroferric oxyhydroxide 2.5 g) [contains corn starch]

Administration: Adult

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

Use: Labeled Indications

Hyperphosphatemia in chronic kidney disease (dialysis dependent), treatment: For control of serum phosphorus levels in patients with chronic kidney disease receiving dialysis.

Medication Safety Issues
Sound-alike/look-alike issues:

Sucroferric oxyhydroxide may be confused with iron sucrose (Venofer), sucrose.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

Roxadustat: Sucroferric Oxyhydroxide may decrease the serum concentration of Roxadustat. Management: Administer roxadustat at least 1 hour after the administration of sucroferric oxyhydroxide. Risk D: 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. Risk D: Consider therapy modification

Pregnancy Considerations

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

Breastfeeding Considerations

Sucroferric oxyhydroxide is not systemically absorbed.

Infant exposure via breast milk is not expected.

Dietary Considerations

One tablet contains ~1.4 g of carbohydrates.

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

Reference Range

Note: Due to the complexity and interdependency of the laboratory parameters used for therapeutic decisions in chronic kidney disease-mineral and bone disorder (CKD-MBD) patients, serial assessments of phosphate, calcium, and parathyroid hormone (PTH) levels should be considered together (KDIGO 2017).

Calcium (total): Normal range: Adults: 8.5 to 10.5 m/dL (2.12 to 2.62 mmol/L) (IOM 2011). Avoid hypercalcemia for CKD stages G3a to G5D (KDIGO 2017)

Phosphorus: 2.5 to 4.5 mg/dL (0.81 to 1.45 mmol/L). Lower elevated phosphorus levels toward the normal range for CKD stages G3a to G5D (KDIGO 2017)

PTH:

CKD stage G3a to G5: Optimal PTH level is unknown; evaluate patients with progressively elevated intact PTH levels or if levels are consistently above the normal range (assay-dependent) (KDIGO 2017)

Dialysis patients: Maintain iPTH within 2 to 9 times the upper limit of normal for the assay used (KDIGO 2017)

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 (Adult Data Unless Noted)

Absorption: Not systemically absorbed

Metabolism: Not metabolized

Excretion: Feces (as bound phosphate)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Velphoro;
  • (AT) Austria: Velphoro;
  • (AU) Australia: Velphoro;
  • (BE) Belgium: Velphoro;
  • (CH) Switzerland: Velphoro;
  • (CZ) Czech Republic: Velphoro;
  • (DE) Germany: Velphoro;
  • (ES) Spain: Velphoro;
  • (FI) Finland: Velphoro;
  • (FR) France: Velphoro;
  • (GB) United Kingdom: Velphoro;
  • (GR) Greece: Velphoro;
  • (HK) Hong Kong: Velphoro;
  • (HR) Croatia: Velphoro;
  • (IE) Ireland: Velphoro;
  • (IN) India: Dynulta | Sucrobind;
  • (IT) Italy: Velphoro;
  • (JP) Japan: P tol;
  • (KR) Korea, Republic of: Velphoro;
  • (KW) Kuwait: Velphoro;
  • (LU) Luxembourg: Velphoro;
  • (MX) Mexico: Velphoro;
  • (MY) Malaysia: Velphoro;
  • (NL) Netherlands: Velphoro;
  • (NO) Norway: Velphoro;
  • (PR) Puerto Rico: Velphoro;
  • (PT) Portugal: Velphoro;
  • (RU) Russian Federation: Velphoro;
  • (SA) Saudi Arabia: Velphoro;
  • (SE) Sweden: Velphoro;
  • (SG) Singapore: Velphoro;
  • (SI) Slovenia: Velphoro
  1. Institute of Medicine (IOM). Dietary Reference Intakes for Calcium and Vitamin D. The National Academies Press; 2011.
  2. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease—mineral and bone disorder (CKD-MBD). Kidney Int Suppl. 2017;7(1):1-59. doi:10.1016/j.kisu.2017.04.001 [PubMed 30675420]
  3. Locatelli F, Del Vecchio L. Iron-based phosphate binders: a paradigm shift in the treatment of hyperphosphatemic anemic CKD patients? J Nephrol. 2017;30(6):755-765. doi:10.1007/s40620-017-0421-y [PubMed 28717990]
  4. Velphoro (sucroferric oxyhydroxide) [prescribing information]. Waltham, MA: Fresenius Medical Care North America; February 2020.
  5. Velphoro (sucroferric oxyhydroxide) [product monograph]. Saint-Laurent, Quebec, Canada: Otsuka Canada Pharmaceutical Inc; August 2021.
Topic 91795 Version 115.0

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