Fosbind Special Precautions

Use Caution in Patients with Gastrointestinal Disorders: The safety of Sevelamer Carbonate has not been established in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery. Use caution in patients with these GI disorders.
Monitor Serum Chemistries: Bicarbonate and chloride levels should be monitored.
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.