Sevelamer Velpharm (Tablets) Instructions for Use

Marketing Authorization Holder

Velpharm-M, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Or

Velpharm-M, LLC (Russia)

ATC Code

V03AE02 (Sevelamer)

Active Substance

Sevelamer (Rec.INN registered by WHO)

Dosage Form

Sevelamer Velpharm

Film-coated tablets 800 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

10 pcs. – blister packs (12 pcs.) – cardboard packs (120 pcs.) – By prescription
10 pcs. – blister packs (15 pcs.) – cardboard packs (150 pcs.) – By prescription
10 pcs. – blister packs (18 pcs.) – cardboard packs (180 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – blister packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
120 pcs. – jars – cardboard packs (120 pcs.) – By prescription
15 pcs. – blister packs (10 pcs.) – cardboard packs (150 pcs.) – By prescription
15 pcs. – blister packs (12 pcs.) – cardboard packs (180 pcs.) – By prescription
15 pcs. – blister packs (2 pcs.) – cardboard packs (30 pcs.) – By prescription
15 pcs. – blister packs (4 pcs.) – cardboard packs (60 pcs.) – By prescription
15 pcs. – blister packs (6 pcs.) – cardboard packs (90 pcs.) – By prescription
15 pcs. – blister packs (8 pcs.) – cardboard packs (120 pcs.) – By prescription
150 pcs. – jars – cardboard packs (150 pcs.) – By prescription
180 pcs. – jars – cardboard packs (180 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription
90 pcs. – jars – cardboard packs (90 pcs.) – By prescription

Clinical-Pharmacological Group

Drug for the treatment of hyperphosphatemia

Pharmacotherapeutic Group

Other therapeutic agents; agents for the treatment of hyperkalemia and hyperphosphatemia

Pharmacological Action

Agent for the treatment of hyperphosphatemia. It is a poly(allylamine hydrochloride) polymer that is not absorbed from the gastrointestinal tract.

By binding phosphates in the digestive tract, it reduces their concentration in the blood serum.

It does not contain calcium and therefore does not cause hypercalcemia, which is observed with the use of other phosphate-binding agents containing calcium.

The effect on blood phosphorus concentration is maintained when taken for 1 year.

Pharmacokinetics

It is not absorbed from the gastrointestinal tract.

Possible systemic absorption and accumulation with long-term use cannot be completely ruled out.

Indications

Prevention of hyperphosphatemia in chronic renal failure in patients on hemodialysis (as part of complex therapy, including calcium preparations, colecalciferol or its analogs).

ICD codes

Dosage Regimen

Take orally, with meals.

For patients not receiving phosphate-binding medications: 800 mg 3 times/day (with a phosphate concentration of 1.76-2.42 mmol/L); 1600 mg 3 times/day (with a phosphate concentration greater than 2.42 mmol/L).

For patients receiving phosphate-binding medications (calcium preparations): use in equivalent doses recalculated per 1 mg of calcium-containing preparations (by base) that the patient took previously. The dose of sevelamer varies from 800 to 4000 mg. The maximum daily dose is 7 g. The dose is selected taking into account the serum phosphate concentration (necessary reduction to 1.76 mmol/L and below).

Adverse Reactions

From the digestive system very common (> 1/10) – nausea, vomiting, abdominal pain, constipation, diarrhea, dyspepsia; common (> 1/100 and < 1/10) – flatulence. Intestinal obstruction has been very rarely observed in clinical practice.

From the CNS very common – headache.

From the cardiovascular system: very common (> 1/10) – increase or decrease in blood pressure.

Dermatological reactions: very common (> 1/10) – pruritus; common (> 1/100 and < 1/10) – rash.

Other very common (> 1/10) – pain of various localization; common (> 1/100 and < 1/10) – pharyngitis.

Contraindications

Hypophosphatemia, intestinal obstruction, simultaneous use with ciprofloxacin, children and adolescents under 18 years of age, hypersensitivity to sevelamer.

Use in Pregnancy and Lactation

Use with caution during pregnancy and during the lactation (breastfeeding) period.

Use in Renal Impairment

Adverse effects occur more frequently in patients with end-stage chronic renal failure.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Use with caution in inflammatory bowel diseases, gastrointestinal motility disorders (including constipation), and in cases of gastrointestinal surgery (in the medical history).

Phosphate concentration should be monitored every 2-3 weeks until stabilization is achieved.

Adverse effects occur more frequently in patients with end-stage chronic renal failure.

Medications for which a reduction in bioavailability may have clinical significance should be taken 1 hour before or 3 hours after taking sevelamer.

Drug Interactions

Sevelamer reduces the bioavailability of ciprofloxacin by 50%.

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.