Mechanism of action

^PrVELPHORO^® is a mixture of polynuclear iron (III)-oxyhydroxide (pn-FeOOH), sucrose, and starches.

Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the phosphate ions throughout the physiological pH range of the GI tract.

Pharmacodynamics

In vitro studies have demonstrated a robust phosphate binding capacity of VELPHORO over the physiological pH range of the GI tract.^1*†

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VOICEOVER:

The kidneys play an important role in the regulation of the body’s phosphate balance.

Excess phosphate is removed from the blood by the kidneys and excreted in the urine.

In people with end stage renal disease, particularly those on dialysis, the kidneys are unable to remove sufficient phosphate, leading to hyperphosphatemia…

^PrVELPHORO^® is indicated for the control of serum phosphorus levels in adult patients with end-stage renal disease on dialysis.

VELPHORO is an iron-based phosphate binder that does not contain calcium, comprised of iron(III)-oxyhydroxide, sucrose and starches.

It is a woodberry flavoured chewable tablet, taken orally with each meal.

VELPHORO binds phosphate in the GI tract and helps reduce phosphate absorption into the bloodstream.

Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the phosphate ions throughout the physiological pH range of the gastrointestinal tract.

Polynuclear iron(III)-oxyhydroxide (pn-FeOOH), the medical component of the product is practically insoluble and therefore not absorbed.

In vitro studies have demonstrated a robust phosphate binding capacity of VELPHORO over the physiological pH range of the gastrointestinal tract.

VELPHORO is a treatment option designed to help control serum phosphorous levels in adult patients with end-stage renal disease on dialysis.

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EFFICACY DATA

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SAFETY AND TOLERABILITY PROFILE

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DOSING AND ADMINISTRATION

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* Clinical significance has not been established.
† pH range of the GI tract: 1.2-7.5.
GI = gastrointestinal.

Reference:

1. VELPHORO Product Monograph. Otsuka Canada Pharmaceutical Inc.

Important Safety Information

Clinical use:

Efficacy and safety in pediatric population (<18 years of age) have not been evaluated.
No overall differences in safety or efficacy were observed between subjects ≥65 and younger subjects.

Contraindications:

Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Patients with hemochromatosis or any other iron accumulation disorders.

Relevant warnings and precautions:

Diabetes, hereditary fructose intolerance, glucose-galactose malabsorption, and sucrase-isomaltase insufficiency
Caution in patients with gastrointestinal issues
VELPHORO may cause black stools which may mask gastrointestinal bleeding
Patients with hepatic/biliary/pancreatic disorders/disease
Monitoring and laboratory tests regarding serum phosphorus and iron
Pregnant or nursing women

Less common clinical trial or post-market adverse reactions:

In the 6-week and 55-week clinical studies, tooth discolouration and product taste were some of the less common (<1%), treatment-related treatment emergent adverse events reported in more than one patient.
Eosinophilic peritonitis has been listed in post-market spontaneous reports.

For more information:

Please consult the Product Monograph at http://velphoromonograph.ca for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-877-341-9245.