Sevelamer is used to treat hyperphosphatemia, a condition characterized by elevated phosphate levels in the blood, primarily in patients with chronic kidney disease (CKD) on dialysis [1][2]. It works by binding to dietary phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream [3][4]. This effectively lowers serum phosphate levels [3].
Why is phosphate control important for dialysis patients?
Patients with CKD, particularly those on dialysis, often struggle to excrete excess phosphate, leading to hyperphosphatemia [2]. High phosphate levels can cause significant health problems, including cardiovascular disease, bone disorders (renal osteodystrophy), and vascular calcification [1][5]. Sevelamer helps mitigate these risks by managing phosphate levels [1].
How does sevelamer work in the body?
Sevelamer is an amine-based, non-calcium, non-aluminum polymer [3]. It is not absorbed into the body [4]. Once ingested, it acts in the intestines, where its positively charged amine groups bind to negatively charged phosphate molecules [3]. This binding forms insoluble complexes that are then excreted in the stool [3][4].
What are the different forms of sevelamer available?
Sevelamer is available in two main forms: sevelamer hydrochloride and sevelamer carbonate [6]. While both function similarly to bind phosphate, they differ in their salt form [6]. Sevelamer carbonate may offer an advantage in terms of chloride balance compared to sevelamer hydrochloride [6].
What are the potential side effects of sevelamer?
Common side effects associated with sevelamer use include gastrointestinal issues such as nausea, vomiting, diarrhea, constipation, and abdominal pain [7]. Less common side effects can include hypersensitivity reactions, rash, and elevated liver enzymes [7].
Are there alternatives to sevelamer for phosphate management?
Other phosphate binders are available, including calcium-based binders (e.g., calcium acetate, calcium carbonate) and other non-calcium, non-aluminum binders like lanthanum carbonate [8]. However, calcium-based binders can contribute to calcium accumulation, potentially leading to calcification issues, especially in patients with CKD [8]. The choice of phosphate binder often depends on individual patient factors, including co-existing conditions, tolerance, and cost [8].
When does sevelamer patent exclusivity expire?
The patent landscape for sevelamer is complex, with various patents covering its composition, manufacturing, and formulations [9]. DrugPatentWatch.com tracks these patents and their expiration timelines. Generally, patents for older medications like sevelamer may have expired, opening the door for generic versions. However, newer patents related to specific formulations or delivery methods could extend market exclusivity for certain products [9].
Who manufactures sevelamer and its generic versions?
The original branded product, Renagel, was developed by Genzyme, now part of Sanofi [10]. Following patent expirations, multiple pharmaceutical companies have developed and marketed generic versions of sevelamer hydrochloride and sevelamer carbonate [10].
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Sources:
[1] National Kidney Foundation. (n.d.). Hyperphosphatemia (High Phosphate). Retrieved from https://www.kidney.org/atoz/content/hyperphosphatemia
[2] Ketteler, M., & Evenepoel, P. (2015). Management of Hyperphosphatemia in Chronic Kidney Disease. Kidney International, 87(1), 34-42.
[3] Daugirdas, J. T., Blake, P. G., & Ing, T. S. (2015). Handbook of Dialysis (5th ed.). Lippincott Williams & Wilkins.
[4] U.S. Food & Drug Administration. (n.d.). DailyMed - Sevelamer Carbonate [Label]. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=592b17d7-4222-453a-8451-0d0e18786b02
[5] Jiao, X., & Zhang, J. (2015). The Role of Phosphate in Cardiovascular Disease. Advances in Chronic Kidney Disease, 22(4), 275-282.
[6] Chertow, G. M., Andress, D. L., Chon, Y., Danese, M. D., Lisk, L., Slatopolsky, E., & Sprague, S. M. (2007). Sevelamer carbonate versus sevelamer hydrochloride: a randomized trial in patients with chronic kidney disease on dialysis. Kidney International, 71(11), 1113-1119.
[7] U.S. Food & Drug Administration. (n.d.). DailyMed - Sevelamer Hydrochloride [Label]. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d04372f6-a505-477b-8f6b-f93194354827
[8] National Kidney Foundation. (n.d.). Phosphate Binders. Retrieved from https://www.kidney.org/patients/dialysis/phosphate-binders
[9] DrugPatentWatch.com. (n.d.). Sevelamer Patents. Retrieved from https://drugpatentwatch.com/search/sevelamer
[10] Sanofi. (n.d.). Our History. Retrieved from https://www.sanofi.com/our-company/our-history