Sucroferric Oxyhydroxide

In the aqueous environment of the GI tract, phosphate binding takes place by ligand exchange between hydroxyl groups and/or water in sucroferric oxyhydroxide and the phosphate in the diet. The bound phosphate is eliminated with feces.

• Velphoro is indicated for the control of serum phosphorus levels in adults and pediatric patients 9 years of age and older with chronic kidney disease (CKD) on dialysis. Velphoro is a phosphate binder indicated for the control of serum phosphorus levels in adult and pediatric patients 9 years of age and older with chronic kidney disease on dialysis.ICD-10: N18.9

• None.contraindicated

Chew or crush Velphoro tablets, do not swallow whole. ( 2.2 ) The recommended starting dose for adults and pediatric patients 12 years of age and older is one 500 mg tablet three times daily with meals. ( 2.1 ) The recommended starting dose for pediatric patients 9 to <12 years of age is one 500 mg tablet two times daily with meals. ( 2.1 ) Adjust dosage by one 500 mg tablet per day as needed until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. Titrate as often as weekly. ( 2.1 ) 2.1 General Dosing Information The recommended starting dose of Velphoro in adults and pediatric patients 12 years of age and older is one 500 mg tablet three times daily with meals. The recommended starting dose of Velphoro in pediatric patients 9 to <12 years of age is one 500 mg tablet two times daily with meals. Monitor serum phosphorus levels and titrate the dose of Velphoro in decrements or increments of one 500 mg tablet per day as needed until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. Titrate as often as weekly. If the recommended daily dose cannot be divided equally among meals, administer the larger dose with the largest meal of the day. In clinical studies, on average, adult patients and pediatric patients 12 years of age and older required 1,500 mg to 2,000 mg (3 to 4 tablets) a day to control serum phosphorus levels; pediatric patients 9 to <12 years of age required on average 1,500 mg (3 tablets) to control serum phosphorus levels.

Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, history of recent major gastrointestinal surgery, or with a history of hemochromatosis or other diseases with iron accumulation have not been included in clinical studies with Velphoro. Monitor effect and iron homeostasis in such patients. ( 5.1 ) 5.1 Monitoring in Patients with Gastrointestinal Disorders or Iron Accumulation Disorders Each chewable tablet contains 500 mg iron (equivalent to 2,500 mg sucroferric oxyhydroxide) [see Clinical Pharmacology (12.3) ] . Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal (GI) surgery, or with a history of hemochromatosis or other diseases with iron accumulation have not been included in clinical studies with Velphoro. Monitor effect and iron homeostasis in such patients.

The most common adverse drug reactions to Velphoro chewable tablets in clinical trials were discolored feces (12%) and diarrhea (6%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care Renal Therapies Group, LLC at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data derived from Velphoro clinical trials reflect exposure to Velphoro in 2 active-controlled clinical studies involving a total of 778 adult patients on hemodialysis and 57 adult patients on peritoneal dialysis exposed for up to 55 weeks. Dosage regimens ranged from 250 mg to 3,000 mg per day. In a parallel design, dose-finding study of Velphoro with a treatment duration of 6 weeks in hemodialysis patients, adverse reactions for Velphoro (N=128) were similar to those reported for the active-control group (sevelamer hydrochloride) (N=26), with the exception of discolored feces (12%) which did not occur in the active-control group. Diarrhea was reported in 6% of patients treated with Velphoro.

8.1 Pregnancy Velphoro is not systemically absorbed following oral administration and maternal use is not expected to result in fetal exposure to the drug. Data Animal Data In pregnant rats given up to 800 mg/kg/day Velphoro by oral gavage from Days 6 to 17 post-mating, no embryo-fetal development toxicity was observed. This dose corresponds to 16 times the maximum recommended clinical dose. In pregnant rabbits given 50, 100 or 200 mg/kg/day Velphoro by oral gavage, from Days 6 to 19 post-mating, the number of fetuses with incomplete/unossified epiphyses and metacarpals/phalanges was increased at the highest dose (corresponding to 4 times the recommended maximum clinical dose). Litter parameters were not adversely affected. In pregnant rats given Velphoro at 100, 280, or 800 mg/kg/day by oral gavage from Day 6 post-mating to lactation Day 20, offspring body weight gain was lower at age 5-13 weeks and neuromuscular function was delayed at the dose of 800 mg/kg/day. This dose represented 16 times the maximum recommended clinical dose. 8.2 Lactation Velphoro is not absorbed systemically following oral administration and breastfeeding is not expected to result in exposure of the child to Velphoro. 8.4 Pediatric Use Velphoro is indicated for the control of serum phosphorus levels in pediatric patients 9 years of age and older with CKD on dialysis.

Metabolism

The active moiety of Velphoro, polynuclear iron (III)-oxyhydroxide (pn-FeOOH), is practically insoluble in water and therefore not absorbed and not metabolized. Its degradation product, mononuclear iron species, can however be released from the surface of pn-FeOOH and be absorbed.

There are no reports of overdosage with Velphoro in patients. Since the absorption of iron from Velphoro is low [see Clinical Pharmacology (12.3) ] , the risk of systemic iron toxicity is low. Hypophosphatemia should be treated by standard clinical practice. Velphoro has been studied in doses up to 3,000 mg per day.

• Nov 27, 2013NDANDA205109Vifor Fresenius

1. 1Death1,14439%
2. 2Diarrhoea30110%
3. 3Nausea943.2%
4. 4Hospitalisation862.9%
5. 5Vomiting842.8%
6. 6Constipation822.8%
7. 7Faeces Discoloured802.7%
8. 8Drug Intolerance652.2%
9. 9Abdominal Discomfort582.0%
10. 10Product Taste Abnormal571.9%
11. 11End Stage Renal Disease511.7%
12. 12Off Label Use511.7%
13. 13Abdominal Pain501.7%
14. 14Chronic Kidney Disease491.7%
15. 15Haemoglobin Increased441.5%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Sucroferric Oxyhydroxide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women
  Completed · Phase 4 · Interventional · 60 enrolled · CMH Multan Institute of Medical Sciences
  NCT06911034updated 2025-04-06
• Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
  Completed · Phase 4 · Interventional · 44 enrolled · SIGA Technologies
  NCT04485039updated 2024-12-27
• Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
  Completed · Phase 2 · Phase 3 · Interventional · 236 enrolled · Ardelyx
  NCT03824587updated 2023-03-06
• Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
  Completed · Phase 4 · Interventional · 17 enrolled · University of Colorado, Denver
  NCT04046263updated 2022-08-31
• PA21 Safety and Efficacy in Adult Chinese Subjects
  Completed · Phase 3 · Interventional · 286 enrolled · Vifor Fresenius Medical Care Renal Pharma
  NCT03644264updated 2021-06-02
• Velphoro and Impact on the Oral Cavity and Gut Microbiome
  Terminated · Observational · 22 enrolled · RWTH Aachen University
  NCT03409757updated 2020-11-25
• Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis (HD) or Peritoneal Dialysis (PD)
  Completed · Observational · 1,400 enrolled · Vifor Fresenius Medical Care Renal Pharma
  NCT02687594updated 2019-10-01
• A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia
  Terminated · Phase 3 · Interventional · 85 enrolled · Vifor Fresenius Medical Care Renal Pharma
  NCT02688764updated 2019-09-10
• The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
  Completed · Phase 2 · Interventional · 40 enrolled · Prim. Priv. Doz. Dr. Daniel Cejka
  NCT03010072updated 2019-07-22

Frequently asked questions

How does Sucroferric Oxyhydroxide work?

In the aqueous environment of the GI tract, phosphate binding takes place by ligand exchange between hydroxyl groups and/or water in sucroferric oxyhydroxide and the phosphate in the diet. The bound phosphate is eliminated with feces.

What is Sucroferric Oxyhydroxide used for?

According to FDA labeling, Sucroferric Oxyhydroxide carries indications including: Velphoro is indicated for the control of serum phosphorus levels in adults and pediatric patients 9 years of age and older with chronic kidney disease (CKD) on dialysis. Velphoro is a phosphate binder indicated for the control of serum phosphorus levels in adult and pediatric patients 9 years of age and older with chronic kidney disease on dialysis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sucroferric Oxyhydroxide?

Sucroferric Oxyhydroxide is classified as Drugs for treatment of hyperkalemia and hyperphosphatemia, Phosphate Chelating Activity, Decreased Inorganic Ion Absorption, Inhibition Large Intestine Fluid/Electrolyte Absorption, Inhibition Small Intestine Fluid/Electrolyte Absorption.

What are the brand names for Sucroferric Oxyhydroxide?

Sucroferric Oxyhydroxide is marketed under brand names including Velphoro.

What are the contraindications for Sucroferric Oxyhydroxide?

Sucroferric Oxyhydroxide labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.