Renvela

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 Information

Renvela 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 meals

Switching 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 g

Dose 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.

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 Information

Renvela 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 meals

Switching 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 g

Dose 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 Instructions

The 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 Tablespoons

Multiple 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.

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 Information

Renvela 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 meals

 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 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 g

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. Dose Titration for All Patients Taking Renvela.

2.2 Sevelamer Carbonate Powder Preparation Instructions

The 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 Tablespoons

Multiple 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.

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 Information

Renvela 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 meals

Switching 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 g

Dose 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 Instructions

The 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 Tablespoons

Multiple 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.