Renagel, 800 mg 180 pcs

Renagel is hypophosphatemic.

Pharmacodynamics

Sevelamer is a polymer of poly(allylamine hydrochloride) that is not absorbed in the GI tract. By binding phosphate in the digestive tract, it reduces the concentration of phosphate in the blood serum.

Sevelamer does not contain calcium; therefore the incidence of episodes of hypercalcemia is lower when using this drug compared to that of patients using calcium-binding phosphate-binding medications.

In clinical studies, the effects on blood phosphorus and calcium levels have been shown to persist for up to one year while taking this medication.

Pharmacokinetics

It is not absorbed in the GI tract.

Indications

Renal disease

• prevention of hyperphosphatemia in adult patients with renal failure on hemodialysis
• hyperphosphatemia in adult patients on hemodialysis

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• as part of a comprehensive therapy to prevent bone damage due to kidney disease and include calcium supplements, 1,25-dihydroxyvitamin D₃ or one of its analogues.

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Active ingredient

Sevelamer

Composition

Active ingredient:

sevelamer 800 mg;

Supplementary substances:

colloidal silicon dioxide;

stearic acid;

Purified water;

Film coating:

Hypromellose low molecular weight E5; Hypromellose high molecular weight E15; diacetylated monoglycerides; purified water;

Composition of the inscription paint:

Iron oxide black (E172); hypromellose (E464); isopropyl alcohol; propylene glycol and purified water;

How to take, the dosage

To be taken by mouth, with meals, on a prescribed diet. The tablets should be swallowed whole, without chewing.

For patients who are not on a phosphate-binding regimen, the dose should be adjusted individually, based on serum phosphate measurements, as shown below.

The starting dose of Renagel tablets^® is 800 mg.

If serum phosphate levels are 1.76-2.42 mmol/L (5.5-7.5 mg/dL) in patients not receiving phosphate-binding agents, the drug should be used 3 times daily with 1 tablet; if >2.42 mmol/L (>7.5 mg/dL), 3 times daily with 2 tablets.

If Renagel^® is prescribed as an alternative phosphate-binding drug, it should be administered at approximately equivalent doses per 1 mg body weight compared to calcium phosphate-binding drugs the patient was previously taking. Serum phosphate concentration should be closely monitored and the dose of Renagel® should be adjusted so that serum phosphate levels decrease to 1.76 mmol/L (5.5 mg/dL) or lower. Serum phosphate levels should be monitored every 2 or 3 weeks until stable serum phosphate levels are achieved, after which regular monitoring of these levels should also be performed. The dosage can vary from 1 to 5 tablets of 800 mg at each meal. The average daily dose is 7 g of Sevelamer.

Interaction

There have been no interaction studies in patients on hemodialysis.

In drug interaction studies in healthy volunteers Renagel^® had no effect on the bioavailability of digoxin, warfarin, enalapril and metoprolol.

The bioavailability of ciprofloxacin was reduced by approximately 50% when coadministered with Renagel in a single-dose study. Therefore, Renagel^® should not be taken simultaneously with ciprofloxacin.

Renagel^® may affect the bioavailability of other drugs. When administering any drug for which decreased bioavailability may have a clinically significant effect on safety or efficacy, this drug should be used at least 1 h before or 3 h after administration of Renagel^®, or the doctor should consider blood levels of the drugs.

Special Instructions

The safety and efficacy of this drug in the treatment of patients under 18 years of age has not been established.

In patients undergoing peritoneal dialysis, the efficacy and safety of the drug have not been studied.

As there are no data on the use of svelamer for more than one year, we cannot completely rule out its possible absorption and accumulation with long-term administration.

The effect on the ability to drive a car or perform work requiring increased speed of physical and mental reactions. No effect detected.

Contraindications

• hypersensitivity to sevelamer or any other drug component;
• hypophosphatemia;
• intestinal obstruction;
• childhood (under 18 years).

With caution: inflammatory bowel disease, GI motility disorders (including constipation), and history of major GI surgery.

Side effects

Gastrointestinal organs: very often – nausea, vomiting, abdominal pain, constipation, diarrhea, dyspepsia; often – flatulence.

CNS disorders: very common – headache.

Systemic system disorders: very common – hypotension, hypertension.

General disorders: very often – pain of various localization.

Skin changes: very often – itching; often – rash.

Infectious complications: often – pharyngitis.

Pregnancy use

The safety of Renagel® in women during pregnancy and lactation has not been established.

In animal studies no embryotoxic or fetotoxic effects of sevelamer were found.

Renagel^® should be administered to pregnant or lactating women only when clearly necessary after careful analysis of the ratio of expected beneficial effects for the mother to risks to the fetus or child.