RENVELA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENVELA (RENVELA).
Renvela (sevelamer carbonate) is a phosphate-binding polymer that binds dietary phosphate in the gastrointestinal tract, inhibiting phosphate absorption and reducing serum phosphate levels. It also binds bile acids, leading to decreased LDL cholesterol.
| Metabolism | Not metabolized; eliminated unchanged in feces as a non-absorbed polymer. |
| Excretion | Sevelamer carbonate is not absorbed systemically; excretion is entirely fecal as the parent compound. Less than 0.01% is absorbed and excreted renally. |
| Half-life | Not applicable as sevelamer is not absorbed. No systemic half-life; local gastrointestinal transit time is approximately 3-4 hours. |
| Protein binding | Not applicable as sevelamer is not absorbed; therefore, no plasma protein binding occurs. |
| Volume of Distribution | Not applicable as sevelamer is not absorbed; Vd is negligible for systemic distribution. |
| Bioavailability | Oral bioavailability is <0.01% due to lack of absorption; it acts locally in the gastrointestinal tract. |
| Onset of Action | Phosphate binding begins within minutes to hours after oral administration; maximal effect on serum phosphate occurs within 2-4 weeks of consistent dosing. |
| Duration of Action | Duration of phosphate binding persists for 4-6 hours after a dose, corresponding to gastrointestinal transit time. Dosing with each meal is required. |
| Action Class | Phosphorous binder |
| Brand Substitutes | Phoscut 400 Tablet, Revlamer 400 Tablet, Acutrol C 400 Tablet, Forsemer 400mg Tablet, Acutrol 400 Tablet, Phoscut 800 Tablet, Revlamer 800 Tablet, Acutrol C 800 Tablet, Acutrol 800 Tablet, Sevenox 800mg Tablet |
Adults: 800 mg orally three times daily with meals; titrate based on serum phosphorus levels up to 2400 mg per meal (7200 mg/day maximum).
| Dosage form | TABLET |
| Renal impairment | Not required; sevelamer is not absorbed systemically and is used specifically for hyperphosphatemia in chronic kidney disease. GFR-based adjustments are not applicable. |
| Liver impairment | No specific guidelines for Child-Pugh based modifications; use caution in severe hepatic impairment due to potential for decreased clearance of sevelamer. |
| Pediatric use | Children (not established): Safety and efficacy not established; off-label use: initial dose 400-800 mg with meals based on body weight, titrate to serum phosphorus levels. |
| Geriatric use | No specific dose adjustment; monitor renal function and serum phosphorus levels; consider lower starting doses due to potential decreased renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENVELA (RENVELA).
| Breastfeeding | Sevelamer is not absorbed systemically, so excretion into breast milk is minimal to none. M/P ratio is not applicable due to lack of systemic absorption. It is generally considered compatible with breastfeeding, but monitor maternal nutritional status as it may reduce absorption of fat-soluble vitamins. Infant exposure via milk is negligible. |
| Teratogenic Risk | RENVELA (sevelamer hydrochloride) is not systemically absorbed, so direct fetal exposure is negligible. No teratogenic effects have been observed in animal studies; however, because it binds phosphate and may reduce absorption of fat-soluble vitamins (A, D, E, K) and folic acid, there is a theoretical risk of fetal harm from maternal vitamin deficiency, particularly vitamin D and K, which could affect bone development and coagulation. Use during pregnancy only if clearly needed. |
■ FDA Black Box Warning
None
| Serious Effects |
["Bowel obstruction","Hypersensitivity to sevelamer or any component"]
| Precautions | ["Bowel obstruction, perforation, and impaction (rare but serious); monitor for gastrointestinal symptoms","May reduce absorption of fat-soluble vitamins (A, D, E, K) and folic acid; consider supplementation","Hypophosphatemia risk with prolonged use","May cause metabolic acidosis due to bicarbonate loss (sevelamer carbonate may mitigate vs hydrochloride form)","Caution in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, or major gastrointestinal surgery"] |
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| Fetal Monitoring | Monitor serum phosphate, calcium, and parathyroid hormone levels regularly to ensure adequate control of hyperphosphatemia. Assess maternal nutritional status including levels of vitamins A, D, E, K and folic acid, especially with long-term use. Consider fetal monitoring for growth and development if prolonged use during pregnancy. |
| Fertility Effects | No known direct effects on fertility. By improving phosphate control in patients with chronic kidney disease, it may indirectly improve overall health and reproductive function. However, no specific studies on fertility have been conducted. |