RENVELA- sevelamer carbonate tablet, film coated
Atlantic Biologicals Corps
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.
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.
|> 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 g 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 (m2)||Starting dose per meal/snack||Titration increases/decreases per doseTitrate by 0.4 gTitrate by 0.8 g|
|≥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 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.
|Renvela Powder Packet Strength||Minimum amount of water for dose preparation(either ounces, mL or Tablespoon)|
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 sachet 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: 0.8 g 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
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.
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 and perforation have also been reported with sevelamer use.
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.
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 received vitamin supplements.
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