Renvela (Sevelamer) for hyperphosphatemia - Drug information

Renvela or Sevelamer inhibits phosphate absorption from the intestinal lumen. It is, therefore, used to treat hyperphosphatemia (high phosphate levels in the blood) in patients with chronic kidney disease. It is specifically useful in patients with normal or high calcium levels since it does not affect serum calcium, bicarbonate and aluminum levels. Sevelamer/ Renvela has a phosphate binding capacity as follows:

  • 400 mg of sevelamer (Renvela) binds to 32 mg of phosphate
  • 800 mg of sevelamer (Renvela) binds to 64 mg of phosphate

Sevelamer Dose in Adults

Renvela / Sevelamer Dose in hyperphosphatemia:

  • 800 to 1,600 mg thrice daily with meals.
  • The dose may be based on serum phosphate levels as follows:
    • Serum phosphate levels of more than 5.5 mg/dL to less than 7.5 mg/dL:
      • 800 mg thrice daily
    • Levels greater than 7.5 mg/dL to less than 9 mg/dL:
      • 1,200 to 1,600 mg thrice daily
    • Levels greater than 9 mg/dL:
      • 1,600 mg thrice daily

The target serum phosphate levels should be maintained between 3.5 to 5.5 mg/dL.

The maximum dose is 13 gms/day of sevelamer hydrochloride or 14 gms/day sevelamer carbonate. The maintenance dose should be adjusted as follows:

  • Levels of more than 5.5 mg/dL:
    • Increase by 400 to 800 mg thrice daily at 2-week intervals
  • 3.5 to 5.5 mg/dL:
    • Continue the same dose
  • Less than 3.5 mg/dL:
    • Reduce the dose by 400 to 800 mg thrice daily

Switching from other phosphate binders:

  • Calcium acetate 667 mg is equivalent to 800 mg Renagel/Renvela
  • Calcium acetate 1,334 mg is equivalent to 1,600 mg as Renagel/Renvela
  • Calcium acetate 2,001 mg is equivalent to 2,400 mg as Renagel/Renvela.

Sevelamer Dose in Childrens

Renvela for Hyperphosphatemia in children:

  • Children older than 6 years and Adolescents:
    • Body surface area of more than 0.75 to less than1.2 m2:
      • 800 mg thrice daily with meals. Titrate the dose by 400 mg per dose at 2 week intervals if needed.
    • BSA more than 1.2 m2 :
      • 1,600 mg thrice daily with meals. Titrate the dose by 800 mg thrice daily at two weeks interval if needed.
  • Infants older than 10 months and Children less than 2 years (limited data available):
    • 140 ± 86 mg/kg/day (5.38 ± 3.24 gms/day)
  • Children older than 2 years and Adolescents:
    • 400 or 800 mg thrice daily with meals

Pregnancy Risk Factor C

  • Sevelamer cannot be absorbed systemically. It can impair the absorption and metabolism of fat-soluble vitamins and folic acid. 
  • Pregnant women should be informed about the need to supplement these vitamins.

Sevelamer use during breastfeeding

  • Breastfeeding does not expose infants to sevelamer.
  • Sevelamer can reduce maternal absorption fat-soluble vitamins, and folic acid. Supplementation may be necessary.

Sevelamer Dose in Renal Disease:

  • Sevelamer has not been studied in patients with renal disease. Dose adjustment is not recommended.

Sevelamer Dose in Liver Disease:

  • No dose adjustment is recommended in patients with liver disease.

Common side effects of sevelamer (Renvela):

  • Endocrine & metabolic:
    • Metabolic acidosis
  • Gastrointestinal: Vomiting, nausea, diarrhea, and dyspepsia.

Less common side effects:

  • Gastrointestinal:
    • Abdominal pain, constipation, flatulence, and peritonitis

Contraindications to Sevelamer (Renvela) include:

  • Severely allergic reactions to sevelamer and any component of this formulation
  • Bowel obstruction
  • Hypophosphatemia
  • Active mucosal injury (necrosis and perforation), ulcerative colitis (ulcerative colitis), and GI bleeding

Warnings and Precautions

  • Gastrointestinal Disease:
    • Patients suffering from the following conditions should take care when using sevelamer.
      • Dysphagia
      • Swallowing disorders
      • Grave gastrointestinal motility disorders
      • Major gastrointestinal surgery.
  • Sevelamer may impair the absorption of fat-soluble vitamins like Vitamin D, E, K, or folic acid absorption.
  • Choking can result from swallowing crushed tablets rapidly expanding in the mouth. You should swallow it whole.
  • Metabolic acidosis should be closely monitored in children

Monitor Serum chemistries including the following:

Frequency of monitoring depends on the severity of the underlying disease and the baseline serum phosphate levels.

  • Patients with CKD stage G3a to G3b:
    • Monitor serum calcium and phosphate every 6 to 12 months
    • Serum PTH levels should be monitored based on baseline levels and bone mineral profile.
  • CKD stage G4:
    • Serum calcium and phosphate every 3 to 6 months;
    • Monitor PTH every 6 to 12 months
  • CKD stage G5 and G5D:
    • Monitor Serum calcium and phosphate every 1 to 3 months
    • PTH every 3 to 6 months.
    • 24-hour urinary calcium and phosphorus
    • Serum Magnesium and alkaline phosphatase every 12 months in the presence of elevated Parathyroid hormone levels.
    • Creatinine, BUN, albumin, and intact parathyroid hormone every 3 to 12 months depending on CKD severity.

How to take Sevelamer?

  • Take the drug with meals.
  • The powder for oral suspension is prepared by mixing it in water, food or a beverage.
  • Do not heat or add to heated foods or liquids and administer it immediately or within 30 minutes of mixing it.
  • The tablets should be swallowed as a whole. It should not be crushed, chewed or broken.
  • It may reduce the absorption of other medications like cyclosporin, levothyroxine, and tacrolimus.
  • Drug levels of these medicines should be monitored. Furthermore, these medicines should be taken hours apart.

Mechanism of action of Sevelamer:

Sevelamer

  • It reduces plasma phosphate levels and binds to dietaryphosphates in the intestinal lumen.
  • This inhibits their absorption. It lowers blood phosphate levels without affecting serum calcium, bicarbonate and aluminum.

The onset of action: It reduced serum phosphate concentrations in a week o two

. It is not absorbed systemically. Excretion is via Feces

Sevelamer International brands:

  • ACCEL-Sevelamer
  • Eurolamer
  • Inophos
  • Invela
  • Lameraseve
  • Postiline
  • Renagel
  • Renosev
  • Renvela
  • Sevel
  • Tasermity

Sevelamer Brands in Pakistan:

Sevelamer HCl [Tabs 400 mg]

Renavel Genome Pharmaceuticals (PVT) LTD.