RENAGEL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENAGEL (RENAGEL).
Sevelamer is a phosphate-binding polymer that binds dietary phosphate in the gastrointestinal tract, preventing its absorption and reducing serum phosphate levels.
| Metabolism | Sevelamer is not absorbed systemically; it is excreted unchanged in feces. |
| Excretion | Renal: 0%; Fecal: >99% (as intact drug, due to non-absorbable polymer). Biliary: negligible. |
| Half-life | Not applicable (non-absorbable polymer; systemic absorption <0.01%). |
| Protein binding | Negligible (<1%) for any absorbed fraction; not bound to plasma proteins. |
| Volume of Distribution | Not applicable (non-absorbable; no systemic distribution; Vd <0.1 L/kg for any trace absorbed). |
| Bioavailability | Oral: <0.01% (essentially 0%); acts locally in GI tract. |
| Onset of Action | Oral: 1-2 weeks for serum phosphate reduction; maximal effect by 2-4 weeks. |
| Duration of Action | Duration corresponds to transit time in the GI tract (approximately 24-48 hours); require continuous daily dosing for sustained effect. |
| Molecular Weight | Sevelamer: >1063.0 Da (polymer, average Mn ~2300 Da) |
Initial dose: 800-1600 mg orally three times daily with meals. Titrate by 1 tablet/capsule per meal based on serum phosphorus levels. Maintenance: typically 2-4 tablets/capsules per meal.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for renal impairment. Recommended for use in patients with chronic kidney disease on dialysis. |
| Liver impairment | No specific guidelines. Caution in severe hepatic impairment due to lack of data. |
| Pediatric use | Not established for children <6 years. For ages ≥6 years: initial dose 800-1600 mg/day divided with meals. Titrate based on serum phosphorus. |
| Geriatric use | No specific dose adjustment. Use lowest effective dose and monitor serum phosphorus levels. |
| 1st trimester | Animal reproduction studies have shown no risk to the fetus; no adequate human studies available. Use only if clearly needed. |
| 2nd trimester | Caution: limited human data; may cause fetal hypophosphatemia or osteomalacia if maternal phosphate depletion occurs. |
| 3rd trimester | Caution: may cause fetal hypophosphatemia or osteomalacia; consider monitoring maternal phosphate and supplementing if needed. |
Clinical note
Comprehensive clinical and safety monograph for RENAGEL (RENAGEL).
| Placental transfer | Unlikely due to high molecular weight and non-absorbed nature; no specific data on placental transfer. |
| Breastfeeding | Not absorbed systemically; unlikely to be present in breast milk. Considered compatible with breastfeeding. |
■ FDA Black Box Warning
None.
| Serious Effects |
Bowel obstructionHypersensitivity to sevelamer or any component
| Precautions | Bowel obstruction, perforation, or impaction (especially in patients with gastrointestinal disorders or prior surgery), Dysphagia and esophageal discomfort, Reduced absorption of fat-soluble vitamins (A, D, E, K) and folic acid, Drug interactions: decreased absorption of mycophenolate mofetil, ciprofloxacin, and levothyroxine |
| Food/Dietary | Must be taken with food to bind dietary phosphate. Avoid high-phosphorus foods (e.g., dairy, nuts, beans, organ meats, cola) to optimize efficacy. Do not take with antacids containing calcium or magnesium; separate by at least 1 hour. May reduce absorption of fat-soluble vitamins; consider supplementation if deficient. |
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| Lactation Rating |
| L1 (Safe) |
| Teratogenic Risk | Renagel (sevelamer hydrochloride) is not absorbed systemically, thus no direct fetal exposure is expected. Animal studies show no teratogenicity at doses up to 16 times the human dose. However, there are no adequate human studies. Use only if clearly needed. |
| Fetal Monitoring | Monitor serum phosphate, calcium, and bicarbonate levels regularly. Assess renal function and electrolyte balance. Fetal monitoring per routine obstetrical care. |
| Fertility Effects | No known effects on fertility. Animal studies showed no impairment at doses up to 16 times the human dose. |
| Clinical Pearls | Renagel (sevelamer hydrochloride) is a non-absorbed phosphate binder used in chronic kidney disease (CKD) patients on dialysis. It does not contain calcium or aluminum, making it preferred for patients with hypercalcemia or vascular calcification risk. Administer with meals to bind dietary phosphate. Monitor serum phosphate, calcium, and bicarbonate levels. May reduce serum bicarbonate; consider co-administration with bicarbonate supplements if metabolic acidosis develops. Tablet formulation can cause dysphagia; consider powder form if needed. |
| Patient Advice | Take this medication exactly as prescribed with each meal or snack to control phosphorus levels. · Swallow tablets whole; do not crush, chew, or cut them. If you have trouble swallowing, ask your doctor about the powder form. · Stick to a low-phosphorus diet as advised by your dietitian; this medicine works best when combined with dietary restrictions. · Common side effects include nausea, vomiting, diarrhea, or constipation. Report severe or persistent symptoms. · Avoid taking other medications at the same time; separate by at least 1 hour before or 3 hours after taking Renagel. |