Sucroferric oxyhydroxide

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Sucroferric oxyhydroxide
Names
Trade namesVelphoro
Clinical data
Drug classPhosphate binder[1]
Main usesHigh phosphate due to chronic kidney disease[2]
Side effectsDiarrhea, discolored feces[1]
Pregnancy
category
  • US: B (No risk in non-human studies)
Routes of
use		By mouth (chewable tablets)
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
Chemical and physical data
FormulaVaries

Sucroferric oxyhydroxide, sold under the brand name Velphoro, is a medication used to treat high phosphate in those on dialysis due to chronic kidney disease (CKD).[2] It is taken by mouth as a chewable tablet.[2][1]

Common side effects include diarrhea and discolored feces.[1] It should not be used in people with hemochromatosis.[1] Use in pregnancy and breastfeeding appears safe.[2] It is a iron-based phosphate binder, which inhibits the gut from absorbing phosphate into the body.[1]

Sucroferric oxyhydroxide was approved for medical use in the United States in in 1957.[2] It was approved in Europe for high phosphate in 2014.[1] In the United Kingdom 500 mg three times per day costs the NHS about £180 as of 2021.[5] In the United States this costs about 1,500 USD.[6]

Medical uses

Sucroferric oxyhydroxide is used for the control of serum phosphorus levels in people with chronic kidney disease (CKD) on dialysis.[7][4][1]

Studies showed that sucroferric oxyhydroxide achieves and maintains phosphate levels in compliance with the KDOQI guidelines.[8][9] The reduction in serum phosphate levels of sucroferric oxyhydroxide-treated patients was non-inferior to that in sevelamer-treated patients. The required daily pill burden was lower with sucroferric oxyhydroxide.[8]

Sucroferric oxyhydroxide binds phosphate under empty and full stomach conditions and across the physiologically relevant pH range of the GI tract.[10]

In a retrospective, real-world study, hyperphosphatemic peritoneal dialysis patients who were prescribed to switch to sucroferric oxyhydroxide from sevelamer, lanthanum carbonate, or calcium acetate had significant reductions in serum phosphorus levels, along with a 53% decrease in the prescribed daily pill burden.[11]

Dosage

In adults the initial dose if 1 tablet of 2.5 gram (500 mg iron) three times per day.[2] This may be increased up to two tablets three times per day.[2]

The chewability of sucroferric oxyhydroxide compares well with that of Calcimagon, a calcium containing tablet used as a standard for very good chewability.[12] Tablets of sucroferric oxyhydroxide easily disintegrated in artificial saliva.

Side effects

The most frequently reported side effects were diarrhoea and discoloured faeces.[7][4] The vast majority of gastrointestinal adverse events occurred early during treatment and abated with time under continued dosing.[7]

Interactions

Drug-interaction studies and post hoc analyses of Phase III studies showed no clinically relevant interaction of sucroferric oxyhydroxide with the systemic exposures to losartan, furosemide, omeprazole, digoxin, and warfarin,[13] the lipid-lowering effects of statins,[14] and oral vitamin D receptor agonists.[15] According to the European label (Summary of Product Characteristics), medicinal products that are known to interact with iron (e.g. doxycycline) or have the potential to interact with Velphoro should be administered at least one hour before or two hours after Velphoro.[7] This allows sucroferric oxyhydroxide to bind phosphate as intended and be excreted without coming into contact with medications in the gut that it might interact with. According to the US prescribing information, Velphoro should not be prescribed with oral levothyroxine.[4] The combination of sucroferric oxyhydroxide and levothyroxine is contraindicated because sucroferric oxyhydroxide contains iron, which may cause levothyroxine to become insoluble in the gut, thereby preventing the intestinal absorption of levothyroxine.[16]

Mechanism of action

Sucroferric oxyhydroxide comprises a polynuclear iron(III)-oxyhydroxide core that is stabilised with a carbohydrate shell composed of sucrose and starch.[17][10] The carbohydrate shell stabilises the iron(III)-oxyhydroxide core to preserve the phosphate adsorption capacity.

Dietary phosphate binds strongly to sucroferric oxyhydroxide in the gastrointestinal (GI) tract. The bound phosphate is eliminated in the faeces and thereby prevented from absorption into the blood. As a consequence of the decreased dietary phosphate absorption, serum phosphorus concentrations are reduced.

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 "Velphoro". Archived from the original on 1 July 2020. Retrieved 15 October 2021.
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 "Sucroferric Oxyhydroxide Monograph for Professionals". Drugs.com. Archived from the original on 1 July 2020. Retrieved 15 October 2021.
  3. ↑ "Velphoro 500 mg chewable tablets - Summary of Product Characteristics (SmPC)". (emc). 9 April 2019. Archived from the original on 2 July 2020. Retrieved 1 June 2020.
  4. ↑ 4.0 4.1 4.2 4.3 "Velphoro- sucroferric oxyhydroxide tablet, chewable". DailyMed. 23 April 2020. Archived from the original on 1 July 2020. Retrieved 1 June 2020.
  5. ↑ BNF (80 ed.). BMJ Group and the Pharmaceutical Press. September 2020 – March 2021. p. 1116. ISBN 978-0-85711-369-6.{{cite book}}: CS1 maint: date format (link)
  6. ↑ "Velphoro Prices, Coupons & Patient Assistance Programs". Drugs.com. Archived from the original on 26 January 2021. Retrieved 15 October 2021.
  7. ↑ 7.0 7.1 7.2 7.3 "Velphoro Product Information" (PDF). European Medicines Agency (EMA). Archived (PDF) from the original on 29 August 2021. Retrieved 24 October 2014.
  8. ↑ 8.0 8.1 Floege J, Covic AC, Ketteler M, Rastogi A, Chong EM, Gaillard S, Lisk LJ, Sprague SM (September 2014). "A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients". Kidney International. 86 (3): 638–47. doi:10.1038/ki.2014.58. PMC 4150998. PMID 24646861.
  9. ↑ Floege J, Covic AC, Ketteler M, Mann JF, Rastogi A, Spinowitz B, Chong EM, Gaillard S, Lisk LJ, Sprague SM (June 2015). "Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients". Nephrology, Dialysis, Transplantation. 30 (6): 1037–46. doi:10.1093/ndt/gfv006. PMC 4438742. PMID 25691681.
  10. ↑ 10.0 10.1 Wilhelm M, Gaillard S, Rakov V, Funk F (April 2014). "The iron-based phosphate binder PA21 has potent phosphate binding capacity and minimal iron release across a physiological pH range in vitro". Clinical Nephrology. 81 (4): 251–8. doi:10.5414/cn108119. PMID 24656315.
  11. ↑ Kalantar-Zadeh K, Parameswaran V, Ficociello LH, Anderson L, Ofsthun NJ, Kwoh C, Mullon C, Kossmann RJ, Coyne DW (2018). "Real-World Scenario Improvements in Serum Phosphorus Levels and Pill Burden in Peritoneal Dialysis Patients Treated with Sucroferric Oxyhydroxide". American Journal of Nephrology. 47 (3): 153–161. doi:10.1159/000487856. PMC 5906196. PMID 29514139.
  12. ↑ Lanz M, Baldischweiler J, Kriwet B, Schill J, Stafford J, Imanidis G (December 2014). "Chewability testing in the development of a chewable tablet for hyperphosphatemia". Drug Development and Industrial Pharmacy. 40 (12): 1623–31. doi:10.3109/03639045.2013.838583. PMID 24010939. S2CID 21386803.
  13. ↑ Chong E, Kalia V, Willsie S, Winkle P (December 2014). "Drug-drug interactions between sucroferric oxyhydroxide and losartan, furosemide, omeprazole, digoxin and warfarin in healthy subjects". Journal of Nephrology. 27 (6): 659–66. doi:10.1007/s40620-014-0080-1. PMC 4242982. PMID 24699894.
  14. ↑ Levesque V, Chong EMF, Moneuse P (2013). "Post-hoc analysis of pharmacodynamic interaction of PA21 with statins in a Phase 3 study of PA21 in dialysis patients with hyperphosphatemia". J Am Soc Nephrol. 24: 758A.{{cite journal}}: CS1 maint: uses authors parameter (link)
  15. ↑ Floege J, Botha J, Chong E et al. (31 May 2014). PA21 does not interact with oral vitamin D receptor agonists: a post hoc analysis of a Phase 3 study. ERA-EDTA congress. Amsterdam, The Netherlands. Abstract no. SP257.{{cite conference}}: CS1 maint: uses authors parameter (link)
  16. ↑ Prescribing Information. Synthroid (levothyroxine). Chicago, IL: Abbott Laboratories. March 1, 2008.
  17. ↑ Vifor Fresenius Medical Care Renal Pharma. Product Monograph 2015.

External links

Identifiers:
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