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.

3 DOSAGE FORMS AND STRENGTHS
Tablets: 800 mg white oval, film-coated, compressed tablets imprinted with “RENVELA 800”

4 CONTRAINDICATIONS
Renvela is contraindicated in patients with bowel obstruction.

5 WARNINGS AND PRECAUTIONS
5.1 Use Caution in Patients with Gastrointestinal Disorders
The safety of Renvela has not been established in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery. Uncommon cases of bowel obstruction and perforation have been reported.

5.2 Monitor Serum Chemistries
Bicarbonate and chloride levels should be monitored.

5.3 Monitor for Reduced 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 received vitamin supplements, which is typical of patients on dialysis.

6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the cl