Renvela
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Uses
Renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same.
Renvela (sevelamer carbonate) is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.
Figure 1. Chemical Structure of Sevelamer Carbonate
a, b = number of primary amine groups a + b = 9
c = number of crosslinking groups c = 1
m = large number to indicate extended polymer network
Renvela® Tablets: Each film-coated tablet of Renvela contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglycerides, microcrystalline cellulose, sodium chloride and zinc stearate. The tablet imprint contains iron oxide black ink.
Sources
Renvela Manufacturers
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Kaiser Foundation Hospitals
![Renvela (Sevelamer Carbonate) Tablet, Film Coated [Kaiser Foundation Hospitals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Renvela | Kaiser Foundation Hospitals
Because of the rapid reaction with the hydrochloric acid in the stomach, the dosing of Renvela powder or tablet is anticipated to be similar to that of the sevelamer hydrochloride salt or tablet.
2.1 General Dosing InformationRenvela should be given three times a day with meals.
Patients Not Taking a Phosphate Binder. The recommended starting dose of Renvela is 0.8 to 1.6 g with meals based on serum phosphorus level. Table1 provides recommended starting doses of Renvela for patients not taking a phosphate binder.
Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Renvela® 800 mg Tablet Renvela Powder > 5.5 and < 7.5 mg/dL 1 tablet three times daily with meals 0.8 g three times daily with meals ≥ 7.5 mg/dL 2 tablets three times daily with meals 1.6 g three times daily with mealsSwitching from Sevelamer Hydrochloride Tablets. For patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels. The highest daily dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.
Switching between Sevelamer Carbonate Tablets and Powder. Use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels.
Switching from Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride and calcium acetate. Table 2 gives recommended starting doses of Renvela based on a patient’s current calcium acetate dose.
Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renvela Calcium Acetate 667 mg
(Tablets per meal) Renvela® 800 mg Tablet
(Tablets per meal) Renvela Powder 1 tablet 1 tablet 0.8 g 2 tablets 2 tablets 1.6 g 3 tablets 3 tablets 2.4 gDose Titration for All Patients Taking Renvela. Titrate the Renvela dose by 0.8 g TID with meals at two-week intervals as necessary with the goal of controlling serum phosphorus within the target range.
Based on clinical studies, the average prescribed daily dose of sevelamer carbonate is approximately 7.2 g per day.
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Cardinal Health
Renvela | Cardinal Health
Because of the rapid reaction with the hydrochloric acid in the stomach, the dosing of Renvela powder or tablet is anticipated to be similar to that of the sevelamer hydrochloride salt or tablet.
2.1 General Dosing InformationRenvela should be given three times a day with meals.
Patients Not Taking a Phosphate Binder. The recommended starting dose of Renvela is 0.8 to 1.6 g with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for patients not taking a phosphate binder.
Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Renvela® 800 mg Tablet Renvela Powder > 5.5 and < 7.5 mg/dL 1 tablet three times daily with meals 0.8 g three times daily with meals ≥ 7.5 mg/dL 2 tablets three times daily with meals 1.6 g three times daily with mealsSwitching from Sevelamer Hydrochloride Tablets. For patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels. The highest daily dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.
Switching between Sevelamer Carbonate Tablets and Powder. Use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels.
Switching from Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride and calcium acetate. Table 2 gives recommended starting doses of Renvela based on a patient’s current calcium acetate dose.
Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renvela Calcium Acetate 667 mg
(Tablets per meal) Renvela® 800 mg Tablet
(Tablets per meal) Renvela Powder 1 tablet 1 tablet 0.8 g 2 tablets 2 tablets 1.6 g 3 tablets 3 tablets 2.4 gDose Titration for All Patients Taking Renvela. Titrate the Renvela dose by 0.8 g three times per day with meals at two-week intervals as necessary with the goal of controlling serum phosphorus within the target range.
2.2 Sevelamer Carbonate Powder Preparation InstructionsThe entire contents of each 0.8 or 2.4 g packet should be placed in a cup and mixed thoroughly with the amount of water described in Table 3.
Table 3. Sevelamer Carbonate Powder Preparation Instructions Renvela Powder
Packet Strength Minimum amount of water for dose preparation
(either ounces, mL or teaspoon/Tablespoon) ounces mL tsp/Tbsp 0.8 g 1 30 6 teaspoons/2 Tablespoons 2.4 g 2 60 4 TablespoonsMultiple packets may be mixed together with the appropriate amount of water. Patients should be instructed to stir the mixture vigorously (it does not dissolve) and drink the entire preparation within 30 minutes and resuspend the preparation right before drinking.
Based on clinical studies, the average prescribed daily dose of sevelamer carbonate is approximately 7.2 g per day.
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Carilion Materials Management
Renvela | Carilion Materials Management
Because of the rapid reaction with the hydrochloric acid in the stomach, the dosing of Renvela powder or tablet is anticipated to be similar to that of the sevelamer hydrochloride salt or tablet.
2.1 General Dosing InformationRenvela should be given three times a day with meals.
The recommended starting dose of Renvela is 0.8 to 1.6 g with meals based on serum phosphorus level. provides recommended starting doses of Renvela for patients not taking a phosphate binder. Patients Not Taking a Phosphate Binder.Table 1
Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Renvela 800 mg Tablet ® Renvela Powder > 5.5 and < 7.5 mg/dL 1 tablet three times daily with meals 0.8 g three times daily with meals ≥ 7.5 mg/dL 2 tablets three times daily with meals 1.6 g three times daily with mealsFor patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels. The highest daily dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis. Switching from Sevelamer Hydrochloride Tablets.
Use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels. Switching between Sevelamer Carbonate Tablets and Powder.
In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride and calcium acetate. gives recommended starting doses of Renvela based on a patient’s current calcium acetate dose. Switching from Calcium Acetate.Table 2
Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renvela Calcium Acetate 667 mg (Tablets per meal)
Renvela 800 mg Tablet (Tablets per meal) ®
Renvela Powder 1 tablet 1 tablet 0.8 g 2 tablets 2 tablets 1.6 g 3 tablets 3 tablets 2.4 gTitrate the Renvela dose by 0.8 g three times per day with meals at two-week intervals as necessary with the goal of controlling serum phosphorus within the target range. Dose Titration for All Patients Taking Renvela.
2.2 Sevelamer Carbonate Powder Preparation InstructionsThe entire contents of each 0.8 or 2.4 g packet should be placed in a cup and mixed thoroughly with the amount of water described in . Table 3
Table 3. Sevelamer Carbonate Powder Preparation Instructions Renvela Powder Packet Strength
Minimum amount of water for dose preparation (either ounces, mL or teaspoon/Tablespoon)
ounces mL tsp/Tbsp 0.8 g 1 30 6 teaspoons/2 Tablespoons 2.4 g 2 60 4 TablespoonsMultiple packets may be mixed together with the appropriate amount of water. Patients should be instructed to stir the mixture vigorously (it does not dissolve) and drink the entire preparation within 30 minutes and resuspend the preparation right before drinking.
Based on clinical studies, the average prescribed daily dose of sevelamer carbonate is approximately 7.2 g per day.
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Genzyme Corporation
Renvela | Genzyme Corporation
Because of the rapid reaction with the hydrochloric acid in the stomach, the dosing of Renvela powder or tablet is anticipated to be similar to that of the sevelamer hydrochloride salt or tablet.
2.1 General Dosing InformationRenvela should be given three times a day with meals.
Patients Not Taking a Phosphate Binder. The recommended starting dose of Renvela is 0.8 to 1.6 g with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for patients not taking a phosphate binder.
Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Renvela® 800 mg Tablet Renvela Powder > 5.5 and < 7.5 mg/dL 1 tablet three times daily with meals 0.8 g three times daily with meals ≥ 7.5 mg/dL 2 tablets three times daily with meals 1.6 g three times daily with mealsSwitching from Sevelamer Hydrochloride Tablets. For patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels. The highest daily dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.
Switching between Sevelamer Carbonate Tablets and Powder. Use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels.
Switching from Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride and calcium acetate. Table 2 gives recommended starting doses of Renvela based on a patient's current calcium acetate dose.
Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renvela Calcium Acetate 667 mg
(Tablets per meal) Renvela® 800 mg Tablet
(Tablets per meal) Renvela Powder 1 tablet 1 tablet 0.8 g 2 tablets 2 tablets 1.6 g 3 tablets 3 tablets 2.4 gDose Titration for All Patients Taking Renvela. Titrate the Renvela dose by 0.8 g three times per day with meals at two-week intervals as necessary with the goal of controlling serum phosphorus within the target range.
2.2 Sevelamer Carbonate Powder Preparation InstructionsThe entire contents of each 0.8 or 2.4 g packet should be placed in a cup and mixed thoroughly with the amount of water described in Table 3.
Table 3. Sevelamer Carbonate Powder Preparation Instructions Renvela Powder
Packet Strength Minimum amount of water for dose preparation
(either ounces, mL or teaspoon/Tablespoon) ounces mL tsp/Tbsp 0.8 g 1 30 6 teaspoons/2 Tablespoons 2.4 g 2 60 4 TablespoonsMultiple packets may be mixed together with the appropriate amount of water. Patients should be instructed to stir the mixture vigorously (it does not dissolve) and drink the entire preparation within 30 minutes and resuspend the preparation right before drinking.
Based on clinical studies, the average prescribed daily dose of sevelamer carbonate is approximately 7.2 g per day.
![Renvela (Sevelamer Carbonate) Tablet, Film Coated [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=970da28b-04e4-4ec8-9d7b-1b74a0ec411d&name=d5e0d75f-5d81-4c05-85ee-71b4651773bf-04.jpg)
![Renvela (Sevelamer Carbonate) Tablet, Film Coated [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=56ccbfc1-4763-46cd-b71c-d6753a4ad23e&name=68151-5113.jpg)
![Renvela (Sevelamer Carbonate) Tablet, Film Coated Renvela (Sevelamer Carbonate) Powder, For Suspension [Genzyme Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e6328460-a57b-450b-a48c-6dcd4b476360&name=renvela-05.jpg)
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