Renagel® (Renagel)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSevelamerSevelamer
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  • Renagel®
    pills inwards 
    Genzyme Europe BV     Netherlands
  • Celamex
    pills inwards 
    FarmSirma Soteks, ZAO     Russia
    • Dosage form: & nbspfilm coated tablets
    Composition:
    active substance: sevelamer - 800 mg;
    auxiliary substances: silicon colloidal dioxide - 3.2 mg,
    stearic acid - 3.2 mg, purified water - 64.2 mg;
    shell:
    low-molecular weight hypersensitivity E5 - 13.4-20.0 mg, hypromellose
    high molecular weight Е15 - 13.4-20.0 mg, diacetylated
    monoglycerides - 8.0 - 12.0 mg;
    ink for inscription (Opakoud WB NS-78-17715 black): iron oxide black E172 - 22%, hypromellose E464 - 7%, isopropyl alcohol - 12%, propylene glycol - 10%, purified water - 49%.

    Description:
    Oval tablets covered with a film shell, almost white, printed on one side with black ink "RENAGEL 800".

    Pharmacotherapeutic group:means for the treatment of hyperphosphatemia.
    ATX: & nbsp

    C.01.E.X   Other combination drugs for the treatment of heart disease

    Pharmacodynamics:
    The drug Renagel® contains sevelamer - a nonabsorbable phosphate-binding polymer of poly (allylamine hydrochloride), which does not contain metals or calcium. It contains multiple amines, separated by one carbon atom from the polymer chain. These amines undergo partial protonation in the intestine and establish ionic and hydrogen bonds with phosphate molecules.Binding phosphates in the digestive tract, the drug Renagel® reduces the phosphate content in the blood serum.
    In patients with chronic renal failure, phosphate accumulation occurs in the body and hyperphosphataemia may develop. The high content of phosphates in the serum contributes to the precipitation (precipitation) of serum calcium, which leads to the development of ectopic calcification (tissues and organs). The risk of developing ectopic calcification increases with an increase in the concentration of phosphates and calcium in the serum (Ca x R) of more than 55 mg / dL. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in renal failure. An increase in the concentration of parathyroid hormone (PTH) in the blood is characteristic of patients with chronic renal failure and may lead to the development of fibrous osteitis. Reducing the concentration of phosphate in the blood serum can help reduce the concentration of PTH in the blood.
    Treatment of hyperphosphatemia consists in reducing the intake of phosphates with food (compliance with the hypophosphate diet), suppressing the absorption of phosphate in the intestine by using phosphate binding drugs andremoval of phosphates by dialysis.
    In clinical studies, it was shown that sevelamer effectively reduces the concentration of phosphates in the blood serum in patients on hemodialysis or peritoneal dialysis.
    In clinical studies, it has also been shown that sevelamer reduces the incidence of episodes of hypercalcemia, compared with patients taking only calcium-containing phosphate binding
    preparations. It was proven that the effect on calcium and phosphate persisted throughout the observation period in a 1-year study.
    It was shown that sevelamer binds bile acids in vitro and in vivo in animal experiments. Bile acid binding by ion exchange resins is a well known method of lowering cholesterol concentration in the blood. In clinical studies, the concentration of total cholesterol and low density lipoprotein cholesterol (LDL) decreased by 15-31%. This effect was noted after 2 weeks and persisted with prolonged application of the sevelamer. The concentrations of triglycerides, high density lipoprotein cholesterol (HDL) and albumin did not change.
    In clinical trials involving patients on hemodialysis, sevelamer with an isolated admission did not have a permanent and clinically significant effect on intact parathyroid hormone (iPTG) serum. In patients with secondary hyperparathyroidism, Renagel® should be used as a combination therapy, which may include calcium-containing dietary supplements, 1,25-dihydroxyvitamin D3, or one of its analogues in order to reduce the concentration of IPPH.

    Pharmacokinetics:
    In a study of 16 healthy volunteers (male and female), it was shown that | 4C-labeled sevelamer not subject to systemic absorption. Studies to study the absorption of sevelamer in patients with kidney disease have not been conducted.

    Indications:
    Hyperphosphatemia in adult patients with chronic renal failure who are on hemodialysis or peritoneal dialysis (to reduce serum phosphate levels).
    The drug Renagel® should be used as part of complex therapy aimed at preventing bone damage due to kidney disease and including calcium-containing food additives, 1,25-dihydroxyvitamin D3 or one of its analogues.

    Contraindications:
    Hypersensitivity to sevelamer or any other component of the drug.
    Hypophosphatemia.
    Intestinal obstruction.
    Children under 18 years of age (safety and efficacy not established).

    Carefully:
    Inflammatory bowel diseases, dysphagia and swallowing difficulties, severe gastrointestinal motility disorders (including severe constipation), extensive surgical operations in the gastrointestinal tract in the anamnesis (see section "Special instructions").
    With simultaneous application with antiarrhythmic and
    antiepileptic drugs (see section "Interaction with other drugs").

    Pregnancy and lactation:
    Pregnancy
    The safety of the drug Renagel 'in women during pregnancy is not established. In studies on there were no embryotoxic or fetotoxic effects of the sevelamer. The drug Renagel1 'should be given to pregnant women only in case of obvious necessity after careful analysis of the ratio of the expected benefit to the mother and the risk to the fetus.
    Breastfeeding period
    The safety of the drug Renagel "in women during breastfeeding is not established.The drug Renagel "should be prescribed to women during the period of breastfeeding only in case of obvious necessity after careful analysis of the ratio of expected benefit and risk for both the mother and the baby." It is necessary to stop breastfeeding during the reception of the drug Renagel. "

    Dosing and Administration:
    Adults and elderly patients (over 65 years of age)
    Patients who do not receive phosphate binding agents
    The recommended initial dose for patients not receiving phosphate binders is 800 to 1600 mg (1 or 2 tablets) with each meal. The dose is selected individually based on the serum phosphate concentration, as shown in the following table:

    Serum phosphate concentration

    The initial dose of the drug Renagel "

    blood in patients not receiving

    800 mg

    phosphate binders


    > 5.5 and <7.5 mg / dL

    1 tablet 3 times a day

    (> 1.76 and <2.42 mmol / L)

    during a meal

    > 7.5 mg / dL

    2 tablets 3 times a day

    (> 2.42 mmol / L)

    during a meal




    Transfer of patients with calcium-containing phosphate binders If patients receiving calcium-containing phosphate binders,go to the reception of the drug Renagel ®, then it should be taken in equivalent doses (in terms of 1 mg of Renagel8 per 1 mg of the previous calcium-containing phosphate binding drug) with monitoring of serum phosphorus concentration to ensure optimal daily doses.
    Titration of the dose (regardless of the previous use of phosphate binding drugs)
    Serum phosphate concentrations should be carefully monitored and the dose of Renagel® R should be adjusted so that the serum phosphate concentration drops to 1.76 mmol / L (5.5 mg / dL) or lower. The concentration of phosphates in the blood serum should be determined every 2-3 weeks until a stable phosphate concentration is reached, then on a regular basis.
    The dose of the drug at each meal can vary from 1 to 5 tablets of 800 mg. The average daily dose is 7 g of sevelamer.
    Mode of application
    Inside, during a meal. Tablets should be swallowed whole, without chewing. Tablets can not be crushed and broken.
    Special patient groups
    Children
    The safety and efficacy of Renagel® in patients under 18 years of age have not been established (see "Contraindications").
    Elderly patients
    For elderly patients, the drug Renagel8 is administered in the same doses as for adult patients.


    Side effects:
    In a clinical study, treatment duration of 52 weeks with parallel groups involving 200 hemodialysis patients and a 12-week clinical trial involving 97 patients on peritoneal dialysis, most adverse events (> 5% of patients), possibly or probably associated with with the use of the drug Renagel®, were related to disorders from the gastrointestinal tract. Adverse reactions noted in these studies, as well as in other studies with a duration of 2 (n = 24) to 8 weeks (n = 82) and a long-term open-label study (n = 192), are presented in accordance with the following grades of incidence World Health Organization: very often (> 10%); often (> 1%, <10%); infrequently (> 0.1%, <1%); rarely (> 0.01%, <0.1%); very rarely (<0.01%); the frequency is unknown (it is not possible to determine the frequency of occurrence of an undesirable phenomenon from the available data).
    Disorders from the gastrointestinal tract
    Very often: nausea, vomiting.
    Often: dyspepsia, diarrhea, abdominal pain, flatulence, anorexia, constipation, gastrointestinal disorders.
    From the skin and subcutaneous tissues
    Often: itching.
    From the side of skeletal muscle tissue
    Often: arthralgia.
    General disorders
    Often: increased fatigue.
    Postmarketing application
    During the post-marketing application, the following side effects were reported (although a direct relationship with the administration of Renagel
    installed): skin itching, rash, abdominal pain, ileus, intestinal
    obstruction, intestinal perforation.

    Overdose:
    Cases of overdose are not described.
    When receiving a healthy volunteer drug in a daily dose of 14 g (equivalent to 17 tablets of 800 mg) for eight days, no undesirable effects were observed. When taking the drug in a daily dose of up to 13 g of patients on hemodialysis, there were no cases of overdose. Since Renagel "is not absorbed in the gastrointestinal tract, the risk of developing systemic toxicity is low.

    Interaction:
    Patients on dialysis did not undergo drug interaction studies.
    In studies of drug interactions involving healthy volunteers, the drug Renagel "did not affect the bioavailability of digoxin, warfarin, enalapril, metoprolol, or iron." The bioavailability of ciprofloxacin decreased by approximately 50% when combined with the drug Renagel "in a single dose study. Therefore, the drug Renagel "should not be taken at the same time as ciprofloxacin.
    In the post-marketing application, very rare cases of an increase in thyroid-stimulating hormone (TTG) in patients receiving both Renagel and levothyroxine sodium. In this regard, it is recommended to carefully monitor the concentration of TSH in patients receiving this combination.
    In the postmarketing application of Renagel, patients who underwent organ transplantation had a decrease in the concentrations of cyclosporine, mycophenolate mofetil and tacrolimus in the blood, which did not lead to any clinically relevant consequences (for example, transplant rejection), but the possibility of interaction,therefore, it is recommended to carefully monitor the concentrations of cyclosporine, mycophenolate mofetil and tacrolimus in the blood, while taking these drugs with the drug Renagel8 'and after its withdrawal.
    The drug Renagel8 can influence the bioavailability of other drugs. With concomitant administration with a drug for which a decrease in bioavailability may have a clinically significant effect on its safety or efficacy, it should be used at least 1 hour before or 3 hours after taking Renagel; otherwise the doctor should consider monitoring the concentration of the drug in the blood.
    Patients receiving antiarrhythmic drugs to treat cardiac arrhythmias and antiepileptic drugs to control convulsive seizures were excluded from clinical trials. The drug Renagel8 should be administered with extreme caution to patients receiving these medications.

    Special instructions:
    The safety and efficacy of Renagel® has not been studied in patients with dysphagia and difficulty swallowing,severe violations of the motility of the gastrointestinal tract (including severe constipation) or in patients after extensive abdominal surgery. In this regard, the drug Renagel8 should be used with caution in patients with listed diseases.
    There are reports (infrequently) of difficulty in swallowing tablets of the drug Renagel. Many of these cases relate to patients with concomitant diseases affecting the swallowing function: for example, swallowing disorders or oro-esophageal anomalies. Therefore, with caution should use Renagel® in this category of patients.
    In patients with renal insufficiency, hypocalcemia or hypercalcemia may develop. The drug Renagel® does not contain calcium. Patients on dialysis should be monitored regularly for serum calcium. In the case of hypocalcemia, the patient should additionally prescribe calcium preparations.
    Patients with chronic renal failure are predisposed to the development of metabolic acidosis. The drug "Renagel '" does not contain any bases, it is recommended to conduct regular monitoring of the concentration of bicarbonates and chlorides in the blood serum.
    Depending on the diet and the nature of chronic renal insufficiency in patients on dialysis, the concentrations of vitamins A, D, E and K can develop. Therefore, if the patient does not take these vitamins, it is necessary to monitor the levels of vitamins A, D and E, and also assess the level of vitamin K by determining the thromboplastin time, and, if necessary, prescribe these vitamins additionally.
    The efficacy and safety of the drug has not been studied in pre-dialysis patients.
    As long as the data on the long-term use of the sevelamer (for more than one year) are not yet available, its possible absorption and accumulation can not be completely ruled out with long-term admission.

    Effect on the ability to drive transp. cf. and fur:
    Influence on ability to driving motor transport and work with mechanisms is not established.

    Form release / dosage:coated tablets 800 mg
    Packaging:
    180 tablets in a vial of high-density polyethylene with a polypropylene lid with protection from children and a sealed coating that breaks down at the first opening.
    1 bottle with instructions for medical use in a cardboard box.
    Storage conditions:
    In a tightly closed vial at a temperature not exceeding 25 ° C.
    Keep out of the reach of children.

    Shelf life:
    3 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001457/08
    Date of registration:14.03.2008
    The owner of the registration certificate:Genzyme Europe BVGenzyme Europe BV Netherlands
    Manufacturer: & nbsp
    Information update date: & nbsp15.09.2015
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