Velphoro^® 500 (Tablets) Instructions for Use

ATC Code

V03AE05 (Iron (III) metahydroxide sucrose complex)

Clinical-Pharmacological Group

Drug for the treatment of hyperphosphatemia

Pharmacotherapeutic Group

Medicinal products for the treatment of hyperkalemia and hyperphosphatemia

Pharmacological Action

A polynuclear complex of β-iron (III) oxyhydroxide (pn-FeOOH), sucrose, and starch.

Phosphate binding occurs through ligand exchange between hydroxyl groups and/or water and phosphate ions within the physiological pH range in the gastrointestinal tract.

Serum phosphorus concentration, as well as the concentration of calcium/phosphorus-containing substance, decreases due to reduced absorption of dietary phosphate.

Pharmacokinetics

The active substance is practically insoluble and, therefore, is not absorbed from the gastrointestinal tract.

However, degradation products, monocyclic iron-containing compounds, may be released from the pn-FeOOH surface and absorbed.

The active substance does not undergo metabolic transformations.

However, degradation products of the β-iron (III) oxyhydroxide, sucrose, and starch complex (mononuclear iron-containing substances) may be released from the surface of the specified polynuclear complex and absorbed from the gastrointestinal tract.

Results from clinical studies indicate low systemic absorption of the iron contained in the active substance.

Data from in vitro studies suggest that the sucrose and starch included in the medicinal product may be broken down into glucose and fructose during digestion.

These substances can be absorbed into the blood.

Data were obtained from animal studies with oral administration of labeled ⁵⁹Fe β-iron (III) oxyhydroxide, sucrose, and starch complex to rats and dogs.

Radioactively labeled iron was detected in feces but not in urine.

Indications

For controlling serum phosphorus concentration in patients with end-stage chronic renal failure who are on hemodialysis or peritoneal dialysis.

Used as part of combination therapy aimed at preventing the development of renal osteodystrophy, in combination with calcium preparations, 1,25-dihydroxycholecalciferol (vitamin D₃) or its analogue, or with calcimimetics.

ICD codes

Dosage Regimen

Tablets

Take orally with meals.

If one dose or more is missed, the usual dose of Velphoro^® 500 should be taken with the next meal.

The recommended starting dose is 1500 mg/day, with a frequency of administration of 3 times/day.

The dose is adjusted under the control of serum phosphorus concentration until an acceptable blood phosphorus level is achieved, with subsequent regular monitoring of phosphorus concentration.

In clinical practice, treatment is based on the need to control serum phosphorus concentration.

The usual maintenance dose that achieves an optimal therapeutic effect is 1500-2000 mg/day.

The maximum recommended dose is 3000 mg/day.

The safety and efficacy of Velphoro^® 500 in children and adolescents under 18 years of age have not been established to date.

Clinical studies in elderly patients (over 65 years of age) using the approved dosage regimen did not reveal any significant problems.

Velphoro^® 500 is used to control blood phosphorus levels in patients with end-stage chronic renal failure who are on hemodialysis or peritoneal dialysis.

Data on the use of the drug in patients with early-stage renal failure are not available.

During clinical studies of the drug, no significant changes in liver transaminase activity or development of liver disorders were identified.

Adverse Reactions

Gastrointestinal system very common – diarrhea, discoloration of feces (observed as expected with oral iron-containing drugs); common – nausea, constipation, vomiting, dyspepsia, abdominal pain, flatulence, tooth enamel discoloration; uncommon – abdominal distension, gastritis, abdominal discomfort, dysphagia, GERD, tongue discoloration.

Metabolism uncommon – hypercalcemia; hypocalcemia.

Nervous system uncommon – headache.

Respiratory system uncommon – dyspnea.

Skin and subcutaneous tissues uncommon – pruritus, rash.

Other common – taste perversion; uncommon – fatigue.

Laboratory data significant deviations of safety laboratory test results from the norm were not registered.

Contraindications

Hypersensitivity to the active substance or excipients of the drug used; hemochromatosis and any other iron storage disorders; hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency; age under 18 years.

With caution

In patients with peritonitis during peritoneal dialysis, severe gastrointestinal or liver disorders, as well as in patients after extensive gastrointestinal surgery, use only after a thorough benefit/risk assessment.

Use in Pregnancy and Lactation

Data on use in pregnant women are not available.

In studies of reproductive toxicity in animals, no adverse effects of this agent on reproductive function and intrauterine development in animals, on the course of pregnancy and childbirth, development of the embryo/fetus or postnatal development were identified.

Use with caution during pregnancy.

Data on use during breastfeeding are not available.

Since the absorption of iron contained in the active substance is minimal, its excretion into breast milk is unlikely.

The decision to continue breastfeeding or treatment with this agent should be made taking into account the benefits of breastfeeding for the child and the benefits of treatment with the drug for the mother.

Use in Hepatic Impairment

During clinical studies, no significant changes in liver transaminase activity or development of liver disorders were identified.

Use in Renal Impairment

Used to control blood phosphorus levels in patients with end-stage chronic renal failure who are on hemodialysis or peritoneal dialysis.

Pediatric Use

Contraindicated in patients under 18 years of age.

Geriatric Use

Clinical studies in elderly patients (over 65 years of age) using the approved dosage regimen did not reveal any significant specific features.

Special Precautions

The use of this agent may visually mask gastrointestinal bleeding.

It may have a negative effect on teeth due to the sucrose content.

This agent contains starches, which should be considered when it is necessary to use it in patients with gluten allergy, celiac disease, or diabetes mellitus.

Drug Interactions

In vitro studies have established drug interaction (adsorptive effect of this agent) with the following drugs: doxercalciferol, paricalcitol, alendronate, cephalexin, doxycycline and levothyroxine, atorvastatin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazide, metformin, metoprolol, nifedipine, pioglitazone, simvastatin and quinidine.

When prescribing any drug that interacts with iron, such a drug should be taken no later than 1 hour before or 2 hours after taking Velphoro^® 500.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.