See the DrugPatentWatch profile for Sevelamer
Sevelamer carbonate is a medication available in an 800 mg dosage. It is used to treat hyperphosphatemia, a condition characterized by high levels of phosphate in the blood, often seen in patients with chronic kidney disease [1].
What is Sevelamer Carbonate Used For?
Sevelamer carbonate works by binding to phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream [1]. This helps to lower phosphate levels in patients who are unable to adequately control them through dialysis alone or who are not adequately treated with phosphate binders [2]. It is prescribed for adults and children aged 6 years and older with chronic kidney disease on dialysis [1].
How Does Sevelamer Carbonate Work?
As a phosphate binder, sevelamer carbonate is a non-calcium, aluminum-free polymer. When taken with meals, it interacts with dietary phosphate in the gut, forming an insoluble complex that is then eliminated from the body. This process effectively reduces the amount of phosphate absorbed by the body [1].
How Long Does It Take for Sevelamer Carbonate to Work?
The effects of sevelamer carbonate on serum phosphate levels can typically be observed within a few weeks of initiating treatment. However, the time it takes to reach target phosphate levels can vary depending on individual patient response and adherence to the medication regimen [1].
What Are the Side Effects of Sevelamer Carbonate?
Common side effects associated with sevelamer carbonate include nausea, vomiting, diarrhea, constipation, abdominal pain, and flatulence. Less common but potentially serious side effects may include intestinal obstruction, perforation, or bezoar formation, particularly in patients with pre-existing gastrointestinal motility disorders [1].
What Other Dosages of Sevelamer Carbonate are Available?
Sevelamer carbonate is also available in other dosage strengths, such as 400 mg tablets, to allow for individualized titration of the dose based on patient response and phosphate levels [1].
What is the Brand Name for Sevelamer Carbonate?
Sevelamer carbonate is marketed under the brand name Renvela [1].
How Does Sevelamer Carbonate Compare to Other Phosphate Binders?
Sevelamer carbonate is an alternative to other classes of phosphate binders, including calcium-based binders (like calcium acetate or calcium carbonate) and other non-calcium, non-aluminum binders (like sevelamer hydrochloride) [2]. Compared to calcium-based binders, sevelamer carbonate does not contribute to calcium accumulation, which can be a concern in patients with chronic kidney disease [1]. Sevelamer hydrochloride binds phosphate in a similar manner, but sevelamer carbonate has the advantage of not contributing to metabolic acidosis [2].
Are There Any Alternatives to Sevelamer Carbonate?
Alternatives to sevelamer carbonate include other prescription phosphate binders, such as calcium acetate, calcium carbonate, sevelamer hydrochloride, and lanthanum carbonate. Dietary modifications to reduce phosphate intake are also a crucial part of managing hyperphosphatemia [2].
Can Patients Take Sevelamer Carbonate with Food?
Yes, sevelamer carbonate should be taken with meals to ensure it can effectively bind to dietary phosphate. It is important to take the medication as prescribed by a healthcare professional [1].
What Happens if a Dose of Sevelamer Carbonate is Missed?
If a dose of sevelamer carbonate is missed, it should be taken as soon as possible with a meal. If it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule should be resumed [1].
Who Manufactures Sevelamer Carbonate?
The original manufacturer of Renvela (sevelamer carbonate) is Genzyme, a Sanofi company. Generic versions are now available from various pharmaceutical manufacturers [3].
What is the Patent Status of Sevelamer Carbonate?
The patent landscape for sevelamer carbonate, including its brand name Renvela, is complex and may involve multiple patents covering the active ingredient, formulations, and methods of use. Information on specific patent expiry dates and any associated litigation or challenges can be found through resources that track pharmaceutical patents [4]. For detailed patent information, DrugPatentWatch.com provides a comprehensive database [4].
What are the Clinical Trial Results for Sevelamer Carbonate?
Clinical trials have demonstrated the efficacy of sevelamer carbonate in reducing serum phosphate levels in patients with chronic kidney disease on dialysis. Studies have shown significant reductions in phosphate and improvements in related parameters like intact parathyroid hormone (iPTH) and serum calcium-x-phosphate product [1][2].
What Are the Regulatory Approvals for Sevelamer Carbonate?
Sevelamer carbonate has received regulatory approval from agencies such as the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis [1].
Sources:
[1] https://www.renvela.com/
[2] https://www.ncbi.nlm.nih.gov/books/NBK560578/
[3] https://www.drugs.com/renvela.html
[4] https://www.drugpatentwatch.com/