Renvela Powder for Oral Suspension Dosage/Direction for Use

General: Starting dose: The recommended starting dose is 2.4 to 4.8 g for adults per day based on clinical needs and phosphorus level. Sevelamer carbonate (Renvela) must be taken three times per day with meals.
The recommended starting dose for pediatric patients is based on the patient's Body Surface Area (BSA) category. Sevelamer carbonate (Renvela) must be taken three times per day with meals and/or snacks. If a pediatric patient eats less than 3 meals/snacks per day, Sevelamer carbonate (Renvela) should only be given per meal/snack and not on an empty stomach. For example, if the patient's Screening BSA is ≥0.75 to <1.2 m² and the patient eats 2 meals/snacks per day that patient will take 0.8 g BID per meal. (See Table 1.)

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For patients previously on phosphate binders (Sevelamer hydrochloride or calcium base), Sevelamer carbonate (Renvela) should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily dose.
Titration and Maintenance: Serum phosphorus levels must be monitored and the dose of Sevelamer carbonate (Renvela) titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Patients taking Sevelamer carbonate (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 adult daily dose is expected to be an average of approximately 6 g per day.
Special Populations: Children: The safety and efficacy of Sevelamer carbonate (Renvela) has not been established in children below the age of 6 years of in children with a BSA below 0.75 m². Sevelamer carbonate (Renvela) is not recommended for use in children below the age of 6 years.
Elderly: There is no evidence for special considerations when Sevelamer carbonate (Renvela) is administered to elderly patients.
Administration: Route of administration is oral.
Sevelamer carbonate (Renvela) powder sachet can be taken three times per day with meals individually or in combination at a dosage based on individual patient requirements to control phosphate levels.
The powder should be dispersed in water (30 ml for 0.8 g powder sachet, 40 ml for 1.6 g powder sachet and 60 ml for 2.4 g powder sachet) prior to administration. Multiple sachets may be mixed together, as long as the appropriate amount of water is used. Patient should drink the preparation within 30 minutes.
As an alternative to water, the powder may be pre-mixed with a small amount of beverage or food (e.g. 4 ounces/120 ml) and consumed within 30 minutes. Do not heat Sevelamer carbonate (Renvela) (e.g., microwave) or add to hot foods or liquids.
Food effect: In all clinical studies patients were instructed to take Sevelamer with meals.