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  • Renvela Powder
    / Sanofi


    Active Ingredient
    Sevelamer Carbonate (anhydrous) 2.4 g/Sachet

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Sachets

    60 x 2.4 g

    partial basket chart 21577 40717

    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 powder for oral suspension must be taken three times per day with meals.
    Titration and Maintenance: Serum phosphorus should 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.
    Method of administration: For oral use. Each sachet of 2.4 g of powder is to be dispersed in 60 ml of water prior to administration. The suspension should be ingested within 30 minutes after being prepared.
    See prescribing information for full details.


    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 have not been studied in children below the age of 18 years. The safety and efficacy have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l. Therefore, treatment is curently not recommended in these patients. The safety and efficacy have not been established in patients with the following disorders: dysphagia; swallowing disorders; severe GI motility disorders, including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion; active inflammatory bowel disease; major GI tract surgery. Fat-soluble vitamins: Serum vitamin A, D, E and K status should be assessed regularly. Serum calcium levels should be monitored at regular intervals and elemental calcium should be given as a supplement if required. Patients with chronic kidney disease are predisposed to developing metabolic acidosis. Monitoring of serum bicarbonate levels is therefore recommended. Patients on peritoneal dialysis should be closely monitored with the prompt recognition and management of any signs and symptoms associated with peritonitis. Caution should be exercised when prescribing to patients also taking anti-arrhytmias and anti-seizure medicdbations. Closer monitoring of patients with hypothyroidism is recommended. Renvela is not indicated for the control of hyperparathyroidism. Treatment should be within the context of multiple therapeutic approach, which could include calcium as supplements, 1,25 – dihydroxy vitamin D3 or one of its analogs to lower the intact parathyroid hormone levels. Pregnancy and lactation: The potential risk to humans is unknown. 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 fetus. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
    See prescribing information for full details.


    Side Effects

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

     


    Drug interactions

    Interaction studies have not been conducted in patients on dialysis. Ciprofloxacin, ciclosporin, mycophenolate mofetil and tacrolimus. Levothyroxine, anti-arrhythmic medicdbinal products.
    See prescribing information for full details.


    Manufacturer
    Genzyme Europe
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