"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
- Patient Information:
Details with Side Effects
Renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
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.
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
|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.
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)|
|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
Storage And Handling
Tablets: Renvela® 800 mg Tablets are supplied as white oval, film-coated, compressed tablets, imprinted with “RENVELA 800”, containing 800 mg of sevelamer carbonate on an anhydrous basis, microcrystalline cellulose, hypromellose, diacetylated monoglycerides, sodium chloride, and zinc stearate.
1 Bottle of 30 ct 800 mg Tablets (NDC 58468-0130-2)
1 Bottle of 270 ct 800 mg Tablets (NDC 58468-0130-1)
Powder: Renvela® for Oral Suspension is supplied as opaque, foil lined, heat sealed, packets containing 0.8 g or 2.4 g of sevelamer carbonate on an anhydrous basis, natural and artificial citrus flavor, propylene glycol alginate, sodium chloride, sucralose, and ferric oxide (yellow).
1 Box (NDC 58468-0131-2) of 90 ct 2.4 g packets (NDC 58468-0131-1)
1 Box (NDC 58468-0132-2) of 90 ct 0.8 g packets (NDC 58468-0132-1)
1 Sample Box (NDC 58468-0131-4) of 90 ct 2.4 g packets (NDC 58468-0131-3)
1 Sample Box (NDC 58468-0131-5) of 15 ct 2.4 g packets (NDC 58468-0131-3)
Storage: Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).
[See USP controlled room temperature]
Protect from moisture.
Distributed by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 USA. Revised: 05/2011
Last reviewed on RxList: 8/3/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Renvela Information
Renvela - User Reviews
Renvela User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.