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Renvela Tablet

Renvela Tablet Dosage/Direction for Use

sevelamer

Manufacturer:

Sanofi Winthrop

Distributor:

sanofi-aventis

Marketer:

Globo Asiatico
Full Prescribing Info
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.)

Click on icon to see table/diagram/image

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 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) is available as tablets or powder for oral suspension.
Sevelamer carbonate (Renvela) 800 mg tablets can be taken three times per day with meals at a dosage based on individual patient requirements to control phosphate levels. Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration.
Food effect: In all clinical studies patients were instructed to take Sevelamer with meals.
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