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Sucroferric oxyhydroxide: Pediatric drug information

Sucroferric oxyhydroxide: Pediatric drug information
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For additional information see "Sucroferric oxyhydroxide: Drug information" and "Sucroferric oxyhydroxide: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Velphoro
Brand Names: Canada
  • Velphoro
Therapeutic Category
  • Phosphate Binder
Dosing: Pediatric

Dosage guidance:

Dosage form information: Each sucroferric oxyhydroxide 2,500 mg tablet contains 500 mg of iron. International considerations: Dosage form(s) and strengths to achieve daily dose may vary.

Hyperphosphatemia in chronic kidney disease, treatment

Hyperphosphatemia in chronic kidney disease, treatment: Note: Use evaluated in pediatric patients with either estimated GFR <30 mL/minute/1.73 m2 or on dialysis.

Initial dosing:

Children 6 to <9 years: Limited data available: Oral: Initial: 250 mg 3 times daily with meals (Ref).

Children ≥9 to <12 years: Oral: Initial: 500 mg twice daily with meals.

Children ≥12 years and Adolescents: Oral: Initial: 500 mg 3 times daily with meals.

Titration of dose: Monitor serum phosphorus levels (as often as weekly), adjust dose in 250 mg/day increments for ages <9 years and 500 mg/day increments for ages ≥9 years at ≥1-week intervals until an acceptable serum phosphorus level achieved; once serum phosphorus is stable, transition to regular monitoring (Ref).

Reported effective doses:

Children 6 to <9 years: Median: 1,000 mg/day in divided doses; maximum daily dose: 2,500 mg/day (Ref).

Children ≥9 to <12 years: Mean: 1,500 mg/day in divided doses; maximum daily dose: 3,000 mg/day.

Children ≥12 years and Adolescents: Mean: 1,500 to 2,000 mg/day in divided doses; maximum daily dose: 3,000 mg/day.

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: Pediatric

Children ≥9 years and Adolescents: Oral: No dosage adjustment necessary; sucroferric oxyhydroxide is indicated for use in chronic kidney disease.

Dosing: Liver Impairment: Pediatric

Children ≥9 years and Adolescents: Oral: There are no dosage adjustments provided in the manufacturer's labeling; however, not systemically absorbed or metabolized.

Dosing: Adult

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

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: Liver Impairment: Adult

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

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 been 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: Pediatric

Oral: Chewable tablets: Chew or crush tablets to administer dose; do not swallow whole. Administer with meals with the total daily dose divided among meals; if unable to divide equally among meals, administer the larger dose with largest meal of the day.

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

Administration: Adult

Oral: Tablets must be chewed or crushed; do not swallow whole. Must administer with meals. The total daily dose should be divided among meals; if the daily dose cannot be divided equally among meals, administer the larger dose with largest meal of the day.

Storage/Stability

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

Use

To control serum phosphorus levels in patients with chronic kidney disease receiving dialysis (FDA approved in ages ≥9 years and adults).

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

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 drug interactions program

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

Tecovirimat: Phosphate Binders may increase serum concentration of Tecovirimat. Risk C: Monitor

Tetracyclines: Sucroferric Oxyhydroxide may decrease 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

Vadadustat: Sucroferric Oxyhydroxide may decrease serum concentration of Vadadustat. Management: Administer vadadustat at least 1 hour before oral sucroferric oxyhydroxide. Risk D: Consider Therapy Modification

Dietary Considerations

One tablet contains ~1.4 g of carbohydrates.

Pregnancy Considerations

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

Monitoring Parameters

General recommendations: Serum chemistries (eg, bicarbonate, chloride, magnesium), creatinine, BUN, and albumin.

KDIGO 2017 guidelines: Note: 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 CKD-mineral and bone disorders.

Children and Adolescents:

CKD

Calcium

Phosphorous

Alkaline Phosphatase

PTH

G2 to G3b

Every 6 to 12 months

Every 6 to 12 months

Based on clinical condition

Based on baseline and progression of disease

G4

Every 3 to 6 months

Every 3 to 6 months

Every 12 months (more often in presence of elevated PTH)

Every 6 to 12 months

G5 and G5d

Every 1 to 3 months

Every 1 to 3 months

Every 12 months (more often in presence of elevated PTH)

Every 3 to 6 months

Reference Range

Corrected total serum calcium (Ref):

CKD stages 3a to 5D: Maintain in age-appropriate normal ranges.

Phosphorus (Ref):

CKD G3a to G5D: Lower elevated phosphorus levels toward the normal range.

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;
  • (RO) Romania: Velphoro;
  • (RU) Russian Federation: Velphoro;
  • (SA) Saudi Arabia: Velphoro;
  • (SE) Sweden: Velphoro;
  • (SG) Singapore: Velphoro;
  • (SI) Slovenia: Velphoro
  1. Greenbaum LA, Jeck N, Klaus G, et al. Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2021;36(5):1233-1244. doi:10.1007/s00467-020-04805-y [PubMed 33106892]
  2. Institute of Medicine (IOM). Dietary Reference Intakes for Calcium and Vitamin D. The National Academies Press; 2011.
  3. 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]
  4. 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]
  5. Refer to manufacturer's labeling.
  6. Velphoro (sucroferric oxyhydroxide) [prescribing information]. Waltham, MA: Fresenius Medical Care North America; August 2024.
  7. Velphoro (sucroferric oxyhydroxide) [prescribing information]. Waltham, MA: Fresenius Medical Care North America; July 2024.
  8. Velphoro (sucroferric oxyhydroxide) [product monograph]. Saint-Laurent, Quebec, Canada: Otsuka Canada Pharmaceutical Inc; August 2021.
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