Sevelamer (Renagel) was listed on the Pharmaceutical Benefits Scheme (PBS) on 1 December 2007 for the treatment of hyperphosphataemia in adults with chronic kidney disease who are on dialysis*.1 Until this listing, sevelamer had been available only on private prescription.
Sevelamer is a polymer that reduces serum phosphate concentration by binding phosphate in the gut.2,3 Calcium-based phosphate binders are first line for the treatment of hyperphosphataemia (unless serum calcium concentration is > 2.4 mmol/L).4 Sevelamer may be an alternative for people taking calcium carbonate (Caltrate, Cal-Sup) for whom hypercalcaemia is a problem.2,4
Monitor serum phosphate concentrations every 2–3 weeks until stable, then at regular intervals.2,3 As with any new drug, the full toxicity profile and long-term effects of sevelamer are unknown.
Other available phosphate binders include aluminium hydroxide (Alu-tab) and lanthanum (Fosrenol) but these are not PBS-listed.2,5
Randomised trials have found no difference in efficacy between sevelamer and calcium (acetate or carbonate) or aluminium hydroxide in reducing serum phosphate concentrations.6-8 However, these trials were small (n = 36-200), unblinded, and short (8-52 weeks). While another trial showed no difference between sevelamer and calcium-based phosphate binders in reducing all-cause mortality (hazard ratio 0.93, 95% confidence interval 0.79 to 1.10, p = 0.40), only half of the randomised patients completed the trial.9
* Hyperphosphataemia in an adult with chronic kidney disease who is on dialysis and whose serum phosphate is not controlled with other products and when: (a) serum phosphate is > 1.6 mmol/L, or
(b) the serum calcium (mmol/L) times phosphate (mmol/L) product is > 4.0 mmol2/L2
- Pharmaceutical Benefits Advisory Committee. Positive Recommendations made by the PBAC — July 2007. Canberra: Australian Government Department of Health and Ageing, 2007. http://www.health.gov.au/internet/wcms/publishing.nsf/Content/pbacrec-july07-positive (accessed 20 August 2007).
- Rossi S, ed. Australian Medicines Handbook 2007. Adelaide: Australian Medicines Handbook Pty Ltd, 2007.
- Genzyme Australasia Pty Ltd. Renagel product information. 30 June 2005. http://www.genzyme.com.au/prod/rena/REN%20ANZ%20PI_Com_%20A0507-01.pdf (accessed 6 September 2007).
- Caring for Australians with renal impairment (CARI). Use of phosphate binders in chronic kidney disease. The CARI Guidelines. Sydney: CARI, 2006. http://www.cari.org.au/The%20use%20of%20phosphate%20binders%20in%20CKD.pdf (accessed 17 September 2007).
- Department of Health and Ageing. PBS for Health Professionals. Canberra, 2007. www.pbs.gov.au (accessed 6 September 2007).
- Manns B, Stevens L, Miskulin D, et al. A systematic review of sevelamer in ESRD and an analysis of its potential economic impact in Canada and the United States. Kidney Int 2004;66:1239-47.
- Qunibi WY, Hootkins RE, McDowell LL, et al. Treatment of hyperphosphataemia in haemodialysis patients: the calcium acetate renagel evaluation (CARE) study. Kidney Int 2004;65:1914-26.
- Katopodis KP, Andrikos EK, Gouva CD, et al. Sevelamer hydrochloride versus aluminum hydroxide: Effect on serum phosphorus and lipids in CAPD patients. Perit Dial Int 2006;26:320-7.
- Suki WN, Zabaneh R, Cangiano JL, et al. Effect of sevelamer and calcium-based phosphate binders on mortality in haemodialysis patients. Kidney Int 2007;doi:10.1038/sj.ki.5002466.