Renvela
(sevelamer carbonate)Dosage & Administration
By using PrescriberAI, you agree to the AI Terms of Use.
Renvela Prescribing Information
Renvela ®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
General Dosing Information
Starting Dose for Adult Patients Not Taking a Phosphate Binder.The recommended starting dose of Renvela is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for adult patients not taking a phosphate binder.
| Serum Phosphorus | Renvela |
|---|---|
| >5.5 and <7.5 mg/dL | 0.8 g three times daily with meals |
| ≥7.5 mg/dL | 1.6 g three times daily with meals |
Dose Titration for Adult Patients Taking Renvela. Titrate the Renvela dose by 0.8 g three times per day with meals at two-week intervals as necessary to achieve target serum phosphorus levels. Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 g per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.
Starting Dose for Pediatric Patients Not Taking a Phosphate Binder.The recommended starting dose for pediatric patients 6 years of age and older is 0.8 to 1.6 g taken three times per day with meals based on the patient's body surface area (BSA) category; see Table 2.
| BSA (m 2) | Starting Dose Per Meal/Snack | Titration Increases/Decreases Per Dose |
|---|---|---|
| ≥0.75 to <1.2 | 0.8 g | Titrate by 0.4 g |
| ≥1.2 | 1.6 g | Titrate by 0.8 g |
Dose Titration for Pediatric Patients Taking Renvela.Titrate the Renvela dose as needed to achieve target levels at two-week intervals based on BSA category, as shown in Table 2.
Switching from Sevelamer Hydrochloride Tablets.For adult patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams.
Switching between Sevelamer Carbonate Tablets and Powder.Use the same dose in grams.
Switching from Calcium Acetate. Table 3 gives recommended starting doses of Renvela based on a patient's current calcium acetate dose.
| Calcium Acetate 667 mg (Tablets per meal) | Renvela |
|---|---|
| 1 tablet | 0.8 g |
| 2 tablets | 1.6 g |
| 3 tablets | 2.4 g |
Sevelamer Carbonate Powder Preparation Instructions
Sevelamer carbonate powder is available in 0.8 or 2.4 g packets. For dose increments of 0.4 g, use one half of a 0.8 g packet. Place the sevelamer carbonate powder in a cup and suspend in the amount of water described in Table 4.
| Amount of Renvela Powder | Minimum Amount of Water for Dose Preparation (either ounces, mL, or tablespoon) | ||
|---|---|---|---|
| Ounces | mL | Tablespoons | |
| 0.4 g | 1 | 30 | 2 |
| 0.8 g | 1 | 30 | 2 |
| 2.4 g | 2 | 60 | 4 |
Instruct patients to stir the mixture vigorously (it does not dissolve), resuspend, if necessary, right before administration, and drink the entire preparation within 30 minutes.
As an alternative to water, the entire contents of the packet may be pre-mixed with a small amount of food or beverage and consumed immediately (within 30 minutes) as part of the meal. Do not heat Renvela powder (e.g., microwave) or add to heated foods or liquids.
Tablets: 800 mg white oval, film-coated, compressed tablets, engraved with RV800 on one side
Powder: 0.8 g and 2.4 g pale-yellow powder packaged in an opaque, foil-lined, heat-sealed packets
Pregnancy
Risk Summary
Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug.
Clinical Considerations
Sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2)] . Consider supplementation.
Data
Animal data
In pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred in mid and high-dose groups (human equivalent doses approximately equal to 3–4 times the maximum clinical trial dose of 13 g). In pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose).
Lactation
Risk Summary
Renvela is not absorbed systemically by the mother following oral administration, andbreastfeeding is not expected to result in exposure of the child to Renvela.
Clinical Considerations
Sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2)] . Consider supplementation.
Pediatric Use
The safety and efficacy of Renvela in lowering serum phosphorus levels was studied in patients 6 years of age and older with CKD. In this study, Renvela was apparently less effective in children with a low baseline serum phosphorus, which described children <13 years of age and children not on dialysis. Given its mechanism of action, Renvela is expected to be effective in lowering serum phosphorus levels in pediatric patients with CKD. Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. No new risks or safety signals were identified with the use of sevelamer carbonate in the trial.
Renvela has not been studied in pediatric patients below 6 years of age.
Geriatric Use
Clinical studies of Renvela did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
Renvela is contraindicated in patients with bowel obstruction.
Renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
Gastrointestinal Adverse Events
Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders, including severe constipation, or major GI tract surgery were not included in the Renvela clinical studies.
Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders.
Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have also been reported with sevelamer use [see Adverse Reactions (6.2)] . Inflammatory disorders may resolve upon Renvela discontinuation. Treatment with Renvela should be re-evaluated in patients who develop severe gastrointestinal symptoms.
Reductions in Vitamins D, E, K (clotting factors) and Folic Acid Levels
In preclinical studies in rats and dogs, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, reduced vitamins D, E, and K (coagulation parameters) and folic acid levels at doses of 6–10 times the recommended human dose. In short-term clinical trials, there was no evidence of reduction in serum levels of vitamins. However, in a one-year clinical trial, 25-hydroxyvitamin D (normal range 10 to 55 ng/mL) fell from 39 ± 22 ng/mL to 34 ± 22 ng/mL (p<0.01) with sevelamer hydrochloride treatment. Most (approximately 75%) patients in sevelamer hydrochloride clinical trials were receiving vitamin supplements.