DOSAGE AND ADMINISTRATION
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.
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.
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.
DOSAGE FORMS AND STRENGTHS
Tablets: 800 mg white oval, film-coated, compressed tablets imprinted
with “RENVELA 800”
Powder: 0.8 g and 2.4 g pale yellow powder packaged in an opaque, foil
lined, heat sealed packet
|