Sevelamer (Renagel) 800 mg tablets PBS listed for adults with chronic kidney disease who are on dialysis Sevelamer (Renagel) 800 mg tablets PBS listed for adults with chronic kidney disease who are on dialysis

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

References

1. 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).
2. Rossi S, ed. Australian Medicines Handbook 2007. Adelaide: Australian Medicines Handbook Pty Ltd, 2007.
3. 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).
4. 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).
5. Department of Health and Ageing. PBS for Health Professionals. Canberra, 2007. www.pbs.gov.au (accessed 6 September 2007).
6. 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.
7. 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.
8. 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.
9. 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.