Action and Spectrum

Actions and spectrum: 

sucroferric oxyhydroxide is an iron-based phosphate binder used in patients having chronic kidney disease (CKD) to treat hyperphosphatemia who are on dialysis. It works by binding to dietary phosphate in the gastrointestinal (GI) tract, thereby preventing its absorption and reducing the overall level of phosphate in the blood. It is typically used as a part of a comprehensive treatment plan that includes dietary changes and other medications. 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Discolored feces (12-16%) 

Diarrhea (6-24%)  

1-10% 

Nausea (10%)  

Post marketing Reports 

Rash 

Tooth discoloration 

Black Box Warning

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

sucroferric oxyhydroxide is contraindicated in patients having hypersensitivity to any of the ingredients in the formulation. It should not be used in patients who have iron overload syndrome, or with a history of iron hypersensitivity. Additionally, it should not be used concomitantly with oral iron supplements or non-absorbable oral preparations of divalent cations or trivalent cations such as magnesium, calcium, aluminum, or zinc, as these may decrease the absorption of sucroferric oxyhydroxide.  

Caution 

sucroferric oxyhydroxide should be used with caution in patients with gastrointestinal (GI) disorders such as inflammatory bowel disease, GI ulcers, or a history of GI surgery. Patients should also be monitored for GI adverse reactions, such as constipation, diarrhea, nausea, vomiting, and abdominal pain. Additionally, caution should be exercised in patients with iron overload, hemochromatosis, or other conditions that increase iron absorption, as Sucroferric oxyhydroxide may increase iron absorption and lead to iron overload.  

Comorbidities 

sucroferric oxyhydroxide may control the serum phosphorus levels in patients undergoing dialysis. It is safe and effective for patients with comorbidities such as hyperparathyroidism, hypertension, and diabetes mellitus, which are common in this patient population. However, caution should be exercised in patients with iron overload or known hypersensitivity to any of the components of Sucroferric oxyhydroxide. 

Pregnancy / Lactation

Pregnancy consideration: pregnancy category is unknown 

Lactation: safety and efficacy are not established  

Pregnancy category: 

• Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester. 
• Category B: There is no evidence of risk to the fetus found in animal reproduction studies and there are not enough studies on pregnant women. 
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women 
• Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh risks over benefits These category drugs should be prohibited for pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

sucroferric oxyhydroxide is an iron-based phosphate binder that works by binding to phosphate in the gastrointestinal tract and forming insoluble complexes that are excreted in the feces. 

The sucroferric oxyhydroxide molecule consists of a core of iron oxyhydroxide, surrounded by a shell of sucrose molecules. When taken orally, the sucrose shell is rapidly degraded by enzymes in the small intestine, releasing the iron oxyhydroxide core. The iron oxyhydroxide then binds to phosphate in the gastrointestinal tract, preventing its absorption and reducing serum phosphate levels.  

Pharmacodynamics: 

sucroferric oxyhydroxide is a phosphate binder that works by binding to dietary phosphate in the gastrointestinal tract, forming non-absorbable complexes that are excreted in the feces. This reduces the amount of phosphate that is absorbed into the bloodstream, which in turn helps to lower serum phosphate levels in patients who are on dialysis. 

sucroferric oxyhydroxide is unique in that it is an iron-based phosphate binder, which allows for an alternative option for patients who may not tolerate or respond to other types of phosphate binders. The iron component of sucroferric oxyhydroxide also provides supplemental iron to patients with CKD who are often iron deficient.  

Pharmacokinetics: 

Absorption 

sucroferric oxyhydroxide is not absorbed systemically after oral administration. 

Distribution 

sucroferric oxyhydroxide remains in the gastrointestinal tract and exerts its therapeutic effect locally by binding to dietary phosphate in the lumen of the intestine, thereby reducing the amount of phosphate that is available for absorption into the bloodstream. 

Metabolism 

As sucroferric oxyhydroxide is not absorbed, it does not undergo metabolism. 

Elimination and excretion 

The majority of sucroferric oxyhydroxide is eliminated in the feces. 

Adminstartion

Administration: 

sucroferric oxyhydroxide is administered orally in the form of chewable tablets. The tablets should be chewed thoroughly before swallowing and taken with meals. The recommended initial dose is 2 to 3 tablets per meal, depending on the serum phosphate level and the patient’s weight.

The dosage can be increased or decreased as necessary to achieve and maintain the target serum phosphate level, but the maximum daily dose should not exceed 15 tablets per day. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: sucroferric oxyhydroxide 

Pronounced: [ soo-kroe-fer-ik-ox-ee-hye-drox-ide]  

Why do we use sucroferric oxyhydroxide? 

sucroferric oxyhydroxide is a phosphate binder used to maintain serum phosphorus levels in patients with chronic kidney disease (CKD) who are on dialysis. It works by binding to dietary phosphate in the gastrointestinal tract, thereby reducing the amount of phosphate absorbed into the bloodstream.

By controlling serum phosphorus levels, sucroferric oxyhydroxide can help prevent complications of CKD, such as bone disease and cardiovascular disease.