Sucroferric Oxyhydroxide (Monograph)

Brand name: Velphoro
Drug class: Phosphate-reducing Agents
Chemical name: Ferric hydroxide oxide
Molecular formula: FeHO₂•xC₁₂H₂₂O₁₁•y(C₆H₁₀O₅)_n
CAS number: 20344-49-4

Medically reviewed by Drugs.com on Dec 4, 2023. Written by ASHP.

Introduction

Phosphate binder used to reduce the intestinal absorption of phosphates.

Uses for Sucroferric Oxyhydroxide

Hyperphosphatemia

Reduction of serum phosphorus in patients with chronic kidney disease (CKD) who are undergoing dialysis.

Sucroferric Oxyhydroxide Dosage and Administration

Administration

Oral Administration

Administer orally in divided doses with meals (in order to bind dietary phosphates efficiently).

No increase in the patient's usual fluid intake is required.

Tablets must be chewed before swallowing; do not swallow whole (intact) tablets. Tablets may be crushed to aid with chewing and swallowing.

If any doses are missed, resume usual dosage schedule with the next meal. Do not replace missed dose(s).

Dosage

Dosage expressed in terms of elemental iron. Each tablet contains 500 mg of iron (equivalent to 2.5 g of sucroferric oxyhydroxide).

Adults

Hyperphosphatemia

Oral

Initially, 500 mg of iron 3 times daily.

Monitor serum phosphorus concentrations and titrate dosage as often as weekly in decrements or increments of 500 mg of iron daily as needed, until target serum phosphorus concentrations are attained; monitor regularly thereafter.

Average dosage of 1.5–2 g of iron daily required to control serum phosphorus concentrations in clinical studies.

Prescribing Limits

Adults

Hyperphosphatemia

Oral

Highest dosage used in phase 3 clinical study was 3 g of iron daily.

Special Populations

No special population dosage recommendations.

Related/similar drugs

sucralfate, Carafate, sevelamer, Renvela, Auryxia, Velphoro

Cautions for Sucroferric Oxyhydroxide

Contraindications

• Manufacturer states none.

Warnings/Precautions

Digestive System and Iron Accumulation Disorders

Studies did not include patients with peritonitis during peritoneal dialysis, clinically important gastric or hepatic disorders, prior major GI surgery, or history of hemochromatosis or other diseases associated with iron accumulation. Monitor effects of sucroferric oxyhydroxide, as well as iron homeostasis, in such patients.

Specific Populations

Pregnancy

Sucroferric oxyhydroxide is not systemically absorbed following oral administration. Fetal exposure to the drug during maternal use not expected.

Lactation

Iron from sucroferric oxyhydroxide is not systemically absorbed; breast-feeding not expected to result in infant exposure to the drug.

Pediatric Use

Safety and efficacy not established in children <18 years of age.

Geriatric Use

No overall differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Diarrhea, discolored feces, nausea.

Drug Interactions

Effects on GI Absorption of Drugs

Possible decreased bioavailability of orally administered drugs given concomitantly; no empiric data concerning avoidance of interactions between sucroferric oxyhydroxide and most oral drugs.

Consider administering sucroferric oxyhydroxide and any concomitant drugs at different times if reduced bioavailability would have a clinically important effect on safety or efficacy. The spacing of doses depends on absorption characteristics of the concomitant drug (e.g., time to peak plasma concentration, formulation [i.e., immediate release or extended release]).

Consider monitoring clinical responses and/or blood concentrations of concomitant drugs with a narrow therapeutic index.

Specific Drugs

Sucroferric Oxyhydroxide Pharmacokinetics

No pharmacokinetic studies performed because of insolubility and degradation characteristics.

Absorption

Bioavailability

Active moiety, polynuclear iron(III)-oxyhydroxide, not absorbed. Degradation product, mononuclear iron species, can be absorbed.

Median uptake of radiolabeled iron in the blood was 0.43 and 0.04% on day 21 in healthy individuals with low iron stores and patients with CKD, respectively, who received radiolabeled sucroferric oxyhydroxide (2 g of iron in 1 day).

Elimination

Metabolism

Active moiety, polynuclear iron(III)-oxyhydroxide, not metabolized.

Sucrose and starch components are digested to absorbable sugars: sucrose to glucose and fructose, starch to maltose and glucose. Each 500-tablet provides 1.4 g of carbohydrates.

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C). Keep in original container and protect from moisture.

Actions

• Phosphate binding in the GI tract occurs via ligand exchange between hydroxyl groups and/or water in sucroferric oxyhydroxide and phosphate in diet ; bound phosphate is excreted in feces.

• Decreases serum phosphorus concentrations and calcium-phosphorus product.

• High phosphate-binding capacity over pH range of 1.2–7.5, with peak capacity at pH 2.5.

• No evidence of iron accumulation during one year of therapy.

• No clinically meaningful changes in concentrations of serum iron, ferritin, transferrin saturation (TSAT), and vitamins A, D, E, and K.

• Age, sex, race, or dialysis modality do not affect efficacy of sucroferric oxyhydroxide.

Advice to Patients

• Importance of adhering to instructions about diet.

• Importance of taking sucroferric oxyhydroxide as directed with meals.

• Importance of chewing sucroferric oxyhydroxide tablets and not swallowing them whole. Inform patients that the tablets may be crushed to aid with chewing and swallowing.

• Importance of instructing patients about any concomitantly used drugs that should be taken at a different time of day than when sucroferric oxyhydroxide is taken.

• Potential for sucroferric oxyhydroxide to cause discolored (dark) stools.

• Importance of informing patients that sucroferric oxyhydroxide may cause teeth discoloration.

• Importance of informing clinicians if a rash develops.

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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