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  • Renvela 800 mg Tablets
    / Sanofi


    Active Ingredient
    Sevelamer Carbonate (anhydrous) 800 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    180 X 800 mg

    partial basket chart 27620 18458

    Related information


    Dosage

    Starting dose: The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Renvela must be taken three times per day with meals. For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Renvela should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
    Titration and Maintenance: Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. Patients taking Renvela should adhere to their prescribed diets. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
    Paediatric population: The safety and efficacy of Renvela has not been established in children below the age of 18 years. Renvela is not recommended in children below the age of 18 years.


    recommended drugs

    Indications

    For the control of hyperphosphatemia in adult patients receiving hemodialysis or peritoneal dialysis.For the control of hyperphosphatemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/l. Should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogs to control the development of renal bone disease.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Hypophosphatemia. Bowel obstruction.


    Special Precautions

    Efficacy and safety of Renvela has not been studied in children below the age of 18 years. The safety and efficacy of Renvela have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l. Therefore Renvela is currently not recommended for use in these patients. The safety and efficacy of Renvela have not been established in patients with the following disorders: Dysphagia, Swallowing disorders, Severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion, Active inflammatory bowel disease, Major gastrointestinal tract surgery Therefore caution should be exercised when Renvela is used in these patients.
    Intestinal obstruction and ileus/subileus: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate. Constipation may be a preceding symptom. Patients who are constipated should be monitored carefully while being treated with Renvela. Renvela treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
    Fat-soluble vitamins: Patients with CKD may develop low levels of fat-soluble vitamins A, D, E and K, depending on dietary intake and the severity of their disease. It cannot be excluded that Renvela can bind fat-soluble vitamins contained in ingested food. In patients not taking supplemental vitamins but on sevelamer, serum vitamin A, D, E and K status should be assessed regularly. It is recommended that vitamin supplements be given if necessary. It is recommended that CKD patients not on dialysis are given vitamin D supplements (approximately 400 IU of native vitamin D daily) which can be part of a multivitamin preparation to be taken apart from their dose of Renvela. In patients undergoing peritoneal dialysis additional monitoring of fat-soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were not measured in a clinical study in these patients.
    Folate deficiency: There is at present insufficient data to exclude the possibility of folate deficiency during long term Renvela treatment. Hypocalcaemia/hypercalcaemia: Patients with CKD may develop hypocalcaemia or hypercalcaemia. Renvela does not contain any calcium. Serum calcium levels should therefore be monitored at regular intervals and elemental calcium should be given as a supplement if required.
    Metabolic acidosis: Patients with chronic kidney disease are predisposed to developing metabolic acidosis. As part of good clinical practice, monitoring of serum bicarbonate levels is therefore recommended.
    Peritonitis: Patients receiving dialysis are subject to certain risks for infection specific to dialysis modality. Peritonitis is a known complication in patients receiving peritoneal dialysis and in a clinical study with sevelamer hydrochloride, a greater number of peritonitis cases were reported in the sevelamer group than in the control group. Patients on peritoneal dialysis should be closely monitored to ensure the correct use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis. Swallowing and choking difficulties Uncommon reports of difficulty swallowing the Renvela tablet have been reported. Many of these cases involved patients with co-morbid conditions including swallowing disorders or oesophageal abnormalities. Caution should be exercised when Renvela is used in patients with difficulty swallowing. Consider using Renvela powder for oral suspension in patients with a history of difficulty swallowing.
    Anti-arrhythmic and anti-seizure medicinal products: Caution should be exercised when prescribing Renvela to patients also taking anti-arrhythmias and anti-seizure medicinal products.
    Hypothyroidism: Closer monitoring of patients with hypothyroidism co-administered with sevelamer carbonate and levothryroxine is recommended.
    Long-term chronic treatment: In a clinical trial of one year, no evidence of accumulation of sevelamer was seen. However the potential absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally excluded.
    Hyperparathyroidism:
    Renvela is not indicated for the control of hyperparathyroidism. In patients with secondary hyperparathyroidism Renvela should be used within the context of a multiple therapeutic approach, which could include calcium as supplements, 1,25 – dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
    For full details see prescribing information.


    Side Effects

    Very common: Nausea, vomiting, upper abdominal pain, constipation.
    Common: Diarrhea, dyspepsia, flatulence, abdominal pain.
    For full details see prescribing information.


    Drug interactions

    Interaction studies have not been conducted in patients on dialysis. In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as Renvela, decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with sevelamer hydrochloride in a single dose study. Consequently, Renvela should not be taken simultaneously with ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with sevelamer hydrochloride without any clinical consequences (i.e graft rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal. Very rare cases of hypothyroidism have been reported in patients co-administered sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, and levothyroxine. Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving sevelamer carbonate and levothyroxine. Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and antiseizure medicinal products for the control of seizure disorders were excluded from clinical trials. Caution should be exercised when prescribing Renvela to patients also taking these medicinal products. In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as Renvela, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. Renvela is not absorbed and may affect the bioavailability of other medicinal products. When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Renvela, or the physician should consider monitoring blood levels.


    Pregnancy and Lactation

    Pregnancy: There are no data from the use of sevelamer in pregnant women. Studies in animals have shown some reproductive toxicity when sevelamer was administered to rats at high doses. Sevelamer has also been shown to reduce the absorption of several vitamins including folic acid. The potential risk to humans is unknown. Renvela should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus.
    Lactation: It is unknown whether sevelamer is excreted in human breast milk. The non-absorbed nature of sevelamer indicates that excretion of sevelamer in breast milk is unlikely. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Renvela should be made taking into account the benefit of breast-feeding to the child and the benefit of Renvela therapy to the woman.
    Fertility: There are no data from the effect of sevelamer on fertility in humans. Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative body surface area.


    Overdose

    No cases of overdose have been reported. Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no undesirable effects. In CKD patients, the maximum average daily dose studied was 14.4 grams of sevelamer carbonate in a single daily dose.


    Manufacturer
    Genzyme Europe
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