Drugs List

Therapeutic Indications

Uses

Hyperphosphataemia equal or > 1.78mmol/l in non dialysed patients
Hyperphosphataemia in >6yrs and BSA >0.75sq m with chronic kidney disease
Hyperphosphataemia in chronic renal failure patients on haemodialysis
Hyperphosphataemia in patients on continuous ambulatory peritoneal dialysis

Contraindications

Children under 6 years
Gastrointestinal obstruction
Hypophosphataemia

Precautions and Warnings

Acute severe inflammatory gastrointestinal disorder
Breastfeeding
Decreased gastrointestinal motility
Dysphagia
Gastrointestinal hypermotility
History of major gastrointestinal surgery
Inflammatory bowel disease
Pregnancy

Re-evaluate therapy in patients who develop gastrointestinal symptoms
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Supplements of trace elements and vitamins may be required
Some formulations contain propylene glycol
Monitor lipid-soluble vitamin levels in patients with renal dysfunction
Monitor patients experiencing constipation
Monitor patients on prolonged therapy
Monitor serum calcium levels
Monitor serum phosphate levels
Monitor serum sodium bicarbonate
Folate deficiency may occur on prolonged therapy

Not all brands are licensed for all indications. Sevelamer hydrochloride is only licensed in patients on haemodialysis and peritoneal dialysis.

The oral suspension should be administered to paediatric patients as the tablet formulation is not suitable.

Serum phosphate levels should be closely monitored and the dose of sevelamer adjusted accordingly with the goal of lowering serum phosphate to 1.76mmol/L (5.5mg/dl) or less.

Patients with renal impairment may develop hypocalcaemia or hypercalcaemia. Sevelamer does not contain calcium. Serum calcium levels should be monitored as is done in normal follow-up of a dialysis patient. Elemental calcium should be given as a supplement in case of hypocalcaemia.

Worsening of acidosis has been reported in patients switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in sevelamer-treated patients compared to patients treated with calcium based binders was observed.

Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels. Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and the vitamins should be supplemented if necessary. Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis.

Monitoring of thyroid stimulating hormone levels is recommended in patients receiving sevelamer and levothyroxine.

Cases of serious inflammatory disorders of the gastrointestinal tract associated with the presence of sevelamer crystals have been reported in literature. When sevelamer is discontinued, the inflammatory disorders may resolve.

Serum chloride may increase during treatment with sevelamer hydrochloride as chloride may be exchanged for phosphorus in the intestinal lumen. Although no clinically significant serum chloride increase has been observed in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a dialysis patient. One gram of sevelamer hydrochloride contains approximately 180mg (5.1mEq) chloride.

Patients receiving peritoneal dialysis are at risk of infection. Peritonitis is a known risk, therefore patients on peritoneal dialysis should be closely monitored for signs and symptoms of peritonitis.

Sevelamer is not recommended in patients with chronic kidney disease not on dialysis with serum phosphorus greater than 1.78mmol/L.

Pregnancy and Lactation

Pregnancy

Use sevelamer with caution during pregnancy.

The manufacturer advises caution if sevelamer is used during pregnancy. At the time of writing there is limited published information regarding the use of sevelamer during pregnancy. Sevelamer inhibits intestinal phosphate absorption by binding phosphorus. The drug is not absorbed into the systemic circulation. The limited animal data suggest a risk of toxicity that may be partially due to a deficiency of fat-soluble vitamins such as vitamin D. The effect of sevelamer on the absorption of vitamins in pregnant women has not been studied. However, supplementation with high oral doses of vitamins, especially fat-soluble vitamins (except vitamin A), might be required, or IV vitamins should be considered.

Lactation

Use sevelamer with caution during breastfeeding.

The manufacturer advises caution if sevelamer is used when breastfeeding. At the time of writing there is limited published information regarding the use of sevelamer during breastfeeding. The drug is not absorbed into the systemic circulation, but it may cause vitamin deficiencies in the mother by preventing intestinal vitamin absorption, especially of fat-soluble vitamins. Because vitamins are excreted into breast milk, thereby further reducing maternal vitamin concentrations, women who are taking sevelamer might have to take higher oral doses of vitamins, especially fat-soluble vitamins (except vitamin A) or IV vitamin administration should be considered.

Side Effects

Abdominal pain
Acidosis
Colitis
Constipation
Crystal deposition in the gastrointestinal tract
Diarrhoea
Diverticulitis
Dyspepsia
Flatulence
Gastro-intestinal perforation
Gastro-intestinal ulceration
Gastrointestinal bleeding
Gastrointestinal tumours
Hyperchloraemia
Hypersensitivity reactions
Ileus
Intestinal necrosis
Intestinal obstruction
Nausea
Peritonitis
Pruritus
Rash
Sub-ileus
Vomiting

Presentation

Oral formulations of sevelamer (hydrochloride and carbonate).

Drugs List

Therapeutic Indications

Uses

Hyperphosphataemia equal or > 1.78mmol/l in non dialysed patients
Hyperphosphataemia in >6yrs and BSA >0.75sq m with chronic kidney disease
Hyperphosphataemia in chronic renal failure patients on haemodialysis
Hyperphosphataemia in patients on continuous ambulatory peritoneal dialysis

Dosage

Sevelamer should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.

Patients taking sevelamer should adhere to their prescribed diets.

Adults

Children

Contraindications

Children under 6 years
Gastrointestinal obstruction
Hypophosphataemia

Precautions and Warnings

Acute severe inflammatory gastrointestinal disorder
Breastfeeding
Decreased gastrointestinal motility
Dysphagia
Gastrointestinal hypermotility
History of major gastrointestinal surgery
Inflammatory bowel disease
Pregnancy

Re-evaluate therapy in patients who develop gastrointestinal symptoms
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Supplements of trace elements and vitamins may be required
Some formulations contain propylene glycol
Monitor lipid-soluble vitamin levels in patients with renal dysfunction
Monitor patients experiencing constipation
Monitor patients on prolonged therapy
Monitor serum calcium levels
Monitor serum phosphate levels
Monitor serum sodium bicarbonate
Folate deficiency may occur on prolonged therapy

Not all brands are licensed for all indications. Sevelamer hydrochloride is only licensed in patients on haemodialysis and peritoneal dialysis.

The oral suspension should be administered to paediatric patients as the tablet formulation is not suitable.

Serum phosphate levels should be closely monitored and the dose of sevelamer adjusted accordingly with the goal of lowering serum phosphate to 1.76mmol/L (5.5mg/dl) or less.

Patients with renal impairment may develop hypocalcaemia or hypercalcaemia. Sevelamer does not contain calcium. Serum calcium levels should be monitored as is done in normal follow-up of a dialysis patient. Elemental calcium should be given as a supplement in case of hypocalcaemia.

Worsening of acidosis has been reported in patients switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in sevelamer-treated patients compared to patients treated with calcium based binders was observed.

Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels. Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and the vitamins should be supplemented if necessary. Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis.

Monitoring of thyroid stimulating hormone levels is recommended in patients receiving sevelamer and levothyroxine.

Cases of serious inflammatory disorders of the gastrointestinal tract associated with the presence of sevelamer crystals have been reported in literature. When sevelamer is discontinued, the inflammatory disorders may resolve.

Serum chloride may increase during treatment with sevelamer hydrochloride as chloride may be exchanged for phosphorus in the intestinal lumen. Although no clinically significant serum chloride increase has been observed in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a dialysis patient. One gram of sevelamer hydrochloride contains approximately 180mg (5.1mEq) chloride.

Patients receiving peritoneal dialysis are at risk of infection. Peritonitis is a known risk, therefore patients on peritoneal dialysis should be closely monitored for signs and symptoms of peritonitis.

Sevelamer is not recommended in patients with chronic kidney disease not on dialysis with serum phosphorus greater than 1.78mmol/L.

Pregnancy and Lactation

Pregnancy

Use sevelamer with caution during pregnancy.

The manufacturer advises caution if sevelamer is used during pregnancy. At the time of writing there is limited published information regarding the use of sevelamer during pregnancy. Sevelamer inhibits intestinal phosphate absorption by binding phosphorus. The drug is not absorbed into the systemic circulation. The limited animal data suggest a risk of toxicity that may be partially due to a deficiency of fat-soluble vitamins such as vitamin D. The effect of sevelamer on the absorption of vitamins in pregnant women has not been studied. However, supplementation with high oral doses of vitamins, especially fat-soluble vitamins (except vitamin A), might be required, or IV vitamins should be considered.

Lactation

Use sevelamer with caution during breastfeeding.

The manufacturer advises caution if sevelamer is used when breastfeeding. At the time of writing there is limited published information regarding the use of sevelamer during breastfeeding. The drug is not absorbed into the systemic circulation, but it may cause vitamin deficiencies in the mother by preventing intestinal vitamin absorption, especially of fat-soluble vitamins. Because vitamins are excreted into breast milk, thereby further reducing maternal vitamin concentrations, women who are taking sevelamer might have to take higher oral doses of vitamins, especially fat-soluble vitamins (except vitamin A) or IV vitamin administration should be considered.

Counselling

Advise the patient that each sachet (2.4g) of powder should be dispersed in 60ml of water prior to administration. Alternatively, the powder can be mixed with a small amount of cold beverage or unheated food. The suspension should be ingested within 30 minutes of being prepared.

Advise the patient that the tablets should be swallowed whole. Do not chew or crush the tablets.

Advise the patient that the medicine should be taken with meals.

Advise the patient that the medicine should be taken 3 hours before or 1 hour after other medications.

Side Effects

Abdominal pain
Acidosis
Colitis
Constipation
Crystal deposition in the gastrointestinal tract
Diarrhoea
Diverticulitis
Dyspepsia
Flatulence
Gastro-intestinal perforation
Gastro-intestinal ulceration
Gastrointestinal bleeding
Gastrointestinal tumours
Hyperchloraemia
Hypersensitivity reactions
Ileus
Intestinal necrosis
Intestinal obstruction
Nausea
Peritonitis
Pruritus
Rash
Sub-ileus
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2020

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Renagel 800 mg film-coated tablets. Genzyme Europe B.V. Revised August 2019.

Summary of Product Characteristics: Renvela 800 mg film-coated tablets. Genzyme Europe B.V. Revised August 2019.

Summary of Product Characteristics: Renvela 0.8g powder for oral suspension. Genzyme Europe B.V. Revised February 2019.

Summary of Product Characteristics: Renvela 2.4 g powder for oral suspension. Genzyme Europe B.V. Revised August 2019.

Summary of Product Characteristics: Sevelamer Hydrochloride 400mg film-coated tablets. Sovereign Medical. Revised September 2019.

Summary of Product Characteristics: Sevelamer Hydrochloride 800mg film-coated tablets. Sovereign Medical. Revised September 2019.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 March 2021