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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENAGEL (RENAGEL).
| Breastfeeding | Sevelamer is not absorbed systemically, so excretion into breast milk is negligible. M/P ratio is not applicable. It is considered compatible with breastfeeding. |
| 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 |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to sevelamer or any component","Bowel obstruction","Severe gastrointestinal motility disorders"]
| 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"] |
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| 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. |