Sevelamer is a phosphate binder used to treat hyperphosphatemia in patients with chronic kidney disease [1]. It belongs to a class of drugs that work by binding to dietary phosphorus in the gastrointestinal tract, preventing its absorption into the bloodstream [2].
How does sevelamer work?
Sevelamer functions as an ion-exchange resin. It contains multiple amine groups that become protonated in the intestinal tract. These positively charged amines bind to negatively charged phosphate molecules, forming an insoluble complex that is then excreted from the body [2]. This mechanism helps to lower serum phosphorus levels in patients [1].
What is the difference between sevelamer and other phosphate binders?
Sevelamer is a non-calcium, non-aluminum based phosphate binder. Unlike calcium-based binders, it does not contribute to calcium accumulation, which can be a concern in patients with chronic kidney disease. It also avoids the risks associated with aluminum, such as aluminum toxicity [2]. Other phosphate binders include calcium acetate, calcium carbonate, lanthanum carbonate, and various aluminum-containing products [3]. Each has a different mechanism and potential side effect profile.
When does sevelamer's patent protection end?
The patent expiration dates for sevelamer can vary by region and specific patent. DrugPatentWatch.com tracks these patent timelines. For example, the original U.S. patent for sevelamer hydrochloride (Renagel) has expired, allowing for generic versions to be developed and marketed [4].
Who manufactures sevelamer and its generics?
The originator of sevelamer hydrochloride was Genzyme, now part of Sanofi [5]. Following patent expiries, multiple pharmaceutical companies have developed and market generic versions of sevelamer, including companies like Fresenius Medical Care and Teva Pharmaceuticals [6].
What are the common side effects of sevelamer?
Commonly reported side effects of sevelamer include gastrointestinal issues such as nausea, vomiting, diarrhea, constipation, and abdominal pain [1]. Less frequent but potential side effects can also occur.
How is sevelamer prescribed and dosed?
Sevelamer is typically prescribed based on the patient's serum phosphorus levels and is administered orally with meals. Dosing is individualized and adjusted as needed to maintain target phosphorus levels [1].
What clinical data supports the use of sevelamer?
Clinical trials have demonstrated sevelamer's efficacy in lowering serum phosphorus levels in patients with chronic kidney disease on dialysis [1][7]. Studies have also explored its effects on lipid profiles and cardiovascular risk factors [7].
Can sevelamer be used in non-dialysis CKD patients?
Sevelamer is indicated for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) not on dialysis who cannot be adequately controlled by dietary phosphorus restriction or when the dietary restriction is not practical [1].
What are the risks of not controlling hyperphosphatemia?
Uncontrolled hyperphosphatemia in chronic kidney disease is associated with significant health risks, including secondary hyperparathyroidism, renal osteodystrophy, vascular calcification, and increased cardiovascular morbidity and mortality [8].
---
Cited Sources:
1. https://www.drugpatentwatch.com/drug/sevelamer
2. https://www.drugpatentwatch.com/drug/sevelamer
3. https://www.drugpatentwatch.com/drug/calcium-acetate
4. https://www.drugpatentwatch.com/drug/sevelamer-hydrochloride
5. https://www.drugpatentwatch.com/companies/sanofi-aventis
6. https://www.drugpatentwatch.com/drug/sevelamer
7. https://www.drugpatentwatch.com/drug/sevelamer
8. https://www.drugpatentwatch.com/drug/sevelamer