Renvela

• Approved Indications:
• Management of hyperphosphatemia in adult and pediatric patients with chronic kidney disease (CKD) undergoing dialysis.
• Reduction of serum phosphate levels to prevent secondary hyperparathyroidism and vascular calcification associated with CKD.
• Off-label/Clinically Accepted Uses:
• Treatment of hyperphosphatemia in non-dialysis-dependent CKD patients (use guided by clinical judgment).
• Adjunctive therapy aimed at controlling phosphate balance to reduce cardiovascular risk in CKD.

• Adults:
• Initial dose typically 800 mg to 1600 mg orally three times daily with meals.
• Dose titrated in 800 mg to 1600 mg increments based on serum phosphate levels.
• Maximum daily dose usually up to 12 grams, divided across meals.
• Pediatrics (≥6 years):
• Starting dose 400 mg to 800 mg orally three times daily with meals.
• Adjust dose according to serum phosphate concentrations.
• Elderly:
• Use standard adult dosing; monitor renal function and tolerability.
• Special Populations:
• No specific dosage adjustments required for mild to moderate hepatic impairment.
• Caution in severe gastrointestinal disorders.
• Administration Route:
• Oral tablets should be swallowed whole with meals; not to be crushed or chewed.
• Oral powder form may be dispersed in water and taken immediately.
• Duration:
• Treatment duration is chronic and dependent on ongoing control of serum phosphate.

Sevelamer carbonate is a non-absorbed, non-calcium, polymeric phosphate binder. It binds phosphate ions in the gastrointestinal tract via ionic and hydrogen bonding, forming insoluble complexes that are excreted in feces. This binding reduces intestinal phosphate absorption, thereby lowering serum phosphate concentrations. Unlike calcium-based phosphate binders, sevelamer carbonate does not increase serum calcium levels, decreasing the risk of hypercalcemia and vascular calcification. The reduction in phosphate helps control secondary hyperparathyroidism in CKD.

• Absorption:
  Not systemically absorbed; remains localized in the gastrointestinal lumen.
• Distribution:
  Confined to the GI tract; no systemic distribution.
• Metabolism:
  Not metabolized.
• Elimination:
  Excreted unchanged in feces as phosphate-bound complexes.
• Onset of Action:
  Serum phosphate levels typically decrease within days of treatment initiation.
• Half-life:
  Not applicable due to lack of systemic absorption.

• Pregnancy:
  Classified as FDA Pregnancy Category B. Animal reproduction studies show no harm to fetus; human data limited. Use only if clearly needed.
• Lactation:
  Minimal systemic absorption suggests low risk during breastfeeding. Use with caution.

• Primary: Phosphate binder
• Subclass: Non-calcium, non-metal polymeric phosphate binder

• Known hypersensitivity to sevelamer carbonate or any excipients.
• Bowel obstruction or severe gastrointestinal motility disorders.

• Use cautiously in patients with gastrointestinal motility disorders, constipation, or risk of bowel obstruction.
• Monitor for signs of bowel obstruction, such as severe abdominal pain or constipation.
• Periodic monitoring of serum phosphate, calcium, and bicarbonate levels is recommended.
• Monitor for metabolic acidosis, especially in patients with underlying acid-base disorders.
• Tablet formulation not recommended in patients with swallowing difficulties.

• Common:
  Nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence.
• Rare but Serious:
  Intestinal obstruction or impaction.
  Severe metabolic acidosis.
  Hypocalcemia when used without calcium supplementation.
• Side effects are generally dose-dependent and often improve with dose adjustment.

• May reduce absorption of concomitant oral medications such as ciprofloxacin, levothyroxine, and mycophenolate mofetil.
• Recommend administering other oral medications at least 1 hour before or 3 hours after sevelamer carbonate.
• No known significant effects on CYP450 enzymes.

• KDIGO 2020 guidelines recommend non-calcium phosphate binders like sevelamer to manage hyperphosphatemia to reduce vascular calcification risk.
• Emphasis on individualized dosing titration based on serum phosphate levels.
• Safety monitoring protocols for metabolic acidosis emphasized in recent renal care guidelines.

• Store at controlled room temperature: 20°C to 25°C (68°F to 77°F).
• Protect from moisture and heat.
• Keep container tightly closed.
• Do not freeze.
• Protect from light exposure.