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Phosphate Binder Pregnancy: Safety has not been established in pregnant women — should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis for both mother and fetus; in animal studies there was no evidence that sevelamer induced embryo-fetal toxicity (§4.6). Breast-feeding: safety has not been established in breast-feeding women — give only if clearly needed after a careful risk/benefit analysis for both mother and infant. Fertility: no human data; sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 2 times the maximum clinical trial dose of 13 g/day.

Sevelamer

Brand names: Renagel, Renvela

Sevelamer is a non-absorbed phosphate-binding agent used to control hyperphosphataemia in patients with chronic kidney disease, particularly those on dialysis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Sevelamer hydrochloride 2.4 g or 4.8 g per day as a starting dose, based on clinical needs and serum phosphorus level, taken three times per day with meals. Using 800 mg tablets: serum phosphate 1.76-2.42 mmol/L (5.5-7.5 mg/dL) — 1 tablet three times per day; serum phosphate > 2.42 mmol/L (> 7.5 mg/dL) — 2 tablets three times per day
Route: Oral — take with meals; tablets must be swallowed whole and not crushed, chewed or broken into pieces
Frequency: Three times per day with meals
Max: No absolute maximum is stated; the SPC states 'The dose range may vary between 1 and 5 tablets of 800 mg per meal', and the average actual daily dose used in the chronic phase of a one-year clinical study was 7 g of sevelamer
Source: UK SPC (eMC) for Renagel 800 mg film-coated tablets (sevelamer HYDROCHLORIDE), §4.2 (https://www.medicines.org.uk/emc/product/207/smpc). Note the salt: this SPC covers sevelamer hydrochloride; sevelamer carbonate (e.g. Renvela) is a separate product with its own SPC — confirm which salt and product the page refers to before publishing. SWITCHING: for patients previously on phosphate binders, Renagel should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses. TITRATION AND MAINTENANCE: serum phosphate levels should be closely monitored and the dose titrated by 0.8 g three times per day (2.4 g/day) increments, with the goal of lowering serum phosphate to 1.76 mmol/L (5.5 mg/dL) or less; serum phosphate should be tested every two to three weeks until a stable level is reached and on a regular basis thereafter. Patients should adhere to their prescribed diets. PAEDIATRIC: safety and efficacy have not been established in patients below the age of 18 years (UK SPC). The US label for sevelamer carbonate states safety and efficacy were studied in patients 6 years of age and older with CKD, that it was apparently less effective in children with a low baseline serum phosphorus (children < 13 years and children not on dialysis), and that it has not been studied in paediatric patients below 6 years of age — no per-kg dose is stated in either, hence paedDose is null; verify any under-18 use against a children's formulary. The eMC bundle did not include §4.5, so the interactions listed below are taken from the US sevelamer CARBONATE label §7 (openFDA) — verify against the UK SPC §4.5 for the correct salt.

Dose adjustments

Renal

The safety and efficacy of this product have not been established in predialysis patients (§4.2). No dose adjustment by renal function is given — the product is used in dialysis patients for hyperphosphataemia.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to sevelamer or to any of the excipients listed in section 6.1
  • Hypophosphataemia
  • Bowel obstruction

Side effects

  • Nausea and vomiting (very common)
  • Diarrhoea, dyspepsia, flatulence, upper abdominal pain and constipation (common)
  • Acidosis and increased serum chloride levels (frequency not known)
  • Abdominal pain, intestinal obstruction, ileus/sub-ileus, diverticulitis and intestinal perforation (uncommon to rare per the SPC table; see the inflammatory gastrointestinal disorders warning in §4.4)
  • Post-marketing: hypersensitivity, gastrointestinal haemorrhage, intestinal ulceration, gastrointestinal necrosis, colitis, intestinal mass, crystal deposit in intestine; pruritus and rash

Interactions

  • Ciprofloxacin — demonstrated interaction with sevelamer; dose separately, taking ciprofloxacin at least 2 hours before or 6 hours after sevelamer (US label Table 5)
  • Mycophenolate mofetil — demonstrated interaction; take at least 2 hours before sevelamer (US label Table 5)
  • Oral medicines where reduced bioavailability would have a clinically significant effect on safety or efficacy (e.g. ciclosporin, tacrolimus, levothyroxine) — consider separating the timing of administration, and where possible monitor clinical response and/or blood levels of concomitant drugs with a narrow therapeutic range
  • Digoxin, enalapril, iron, metoprolol and warfarin — sevelamer did not alter their pharmacokinetics when administered concomitantly (US label Table 5)

Clinical monograph

How it works

Its polymeric structure binds dietary phosphate in the gut, preventing absorption and lowering serum phosphate without adding a calcium load.

Prescribing in practice

  • Take with meals so the binder is present with dietary phosphate; doses taken away from food are ineffective.
  • Use cautiously in gastrointestinal disorders and bowel obstruction, and be alert to constipation and other gastrointestinal effects.
  • Separate administration of certain other medicines, as sevelamer may reduce their absorption; the carbonate form also helps buffer metabolic acidosis.

Monitoring

Monitor serum phosphate, calcium and bicarbonate periodically to guide dose adjustment.

Counselling the patient

  • Always take this medicine with your meals.
  • Tell your clinician if you become constipated or have persistent stomach upset.

Evidence & guidelines

Sevelamer is an established phosphate binder in renal practice, supported by guidelines on chronic kidney disease-mineral and bone disorder.

Reference: KDIGO CKD-MBD Guidelines 2017; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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