RENVELA for ORAL SUSPENSION Rx
Generic Name and Formulations:
Sevelamer carbonate 0.8g, 2.4g; per packet; pwd for oral susp.
Sanofi Genzyme Company
Indications for RENVELA for ORAL SUSPENSION:
Control of serum phosphorus in patients ≥6yrs with chronic kidney disease on dialysis.
Take with meals. Mix with 30mL (0.8g packet) or 60mL (2.4g packet) of water; drink mixture within 30mins. Patients not taking a phosphate binder: serum phosphorus >5.5 and <7.5mg/dL: 800mg 3 times daily; ≥7.5mg/dL: 1.6g 3 times daily. Titrate by 800mg/meal at 2-week intervals to serum phosphorus target range; average max 7.2g/day. Switching from sevelamer HCl or switching between sevelamer carbonate tabs and pwd: use same dose in grams. Switching from calcium acetate: sevelamer carbonate 800mg approximates calcium acetate 667mg (see full labeling).
<6yrs: not established. ≥6yrs: Take with meals. Mix with 30mL (0.4g or 0.8g packet) or 60mL (2.4g packet) of water; drink mixture within 30mins. Patients not taking a phosphate binder: BSA: ≥0.75–<1.2m2: 800mg 3 times daily; titrate by 400mg/dose at 2-week intervals to achieve target levels; ≥1.2m2: 1.6g 3 times daily; titrate by 800mg/dose at 2-week intervals to achieve target levels.
Dysphagia. Swallowing disorders (use susp. form). Severe GI motility disorders. Major GI tract surgery. Pregnancy.
Concomitant with drugs that have a narrow therapeutic index; monitor. Consider separation of administration with cyclosporine, tacrolimus, or levothyroxine. Separate dosing of ciprofloxacin by ≥2hrs before or 6hrs after sevelamer; mycophenolate mofetil by ≥2hrs before sevelamer.
Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, constipation; rare: bowel obstruction, perforation.
Tabs—30, 270; Packets—90