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Cambridge, MA (November 9, 2009) — Genzyme Corp. today announced the U.S. launch of Renvela® (sevelamer carbonate) for oral suspension, a powder dosing option for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renvela is the only phosphate binder available in both tablet and powder dosing options.
"The launch of Renvela powder demonstrates our ongoing commitment to providing new alternatives for kidney disease patients," said Dan Regan, senior vice president and general manager of Genzyme's renal business. "Providing an alternate dosing option is one part of our larger effort to ensure that everyone who can benefit from our therapies has access to them, including those patients who may find it easier to take their treatment in a powder form."
Renvela is a next-generation version of Renagel® (sevelamer hydrochloride), the world's most-prescribed phosphate binder. Like Renagel, Renvela is calcium-free, metal-free, non-absorbed, and does not accumulate. In a clinical study comparing Renvela powder to Renagel tablets, both drugs controlled serum phosphorus within KDOQI recommended ranges when dosed three times a day. This study demonstrated that Renvela powder was an effective, generally well-tolerated phosphate binder that was equivalent to Renagel tablets in controlling serum phosphorus.
At launch, Renvela powder will be available in a 2.4 g packet which is equivalent to three Renvela 800 mg tablets and should be given three times daily with meals. Each 2.4 g packet should be mixed with at least 2 oz of water, an amount that is similar to that which is typically used to take tablets. Based on clinical studies, the average prescribed daily dose of Renvela powder is approximately 7.2 g per day.
Renvela is an effective first-line monotherapy for controlling serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Controlling serum phosphorus is an important element in the care of dialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular morbidity and mortality. Sevelamer provides the added benefit of significant LDL cholesterol reduction.
Sevelamer is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal accumulation. Sevelamer is currently used by more than 350,000 patients worldwide.
Renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with CKD on dialysis. Renvela is contraindicated in patients with bowel obstruction. Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery. Uncommon cases of bowel obstruction and perforation have been reported. Serum bicarbonate and chloride levels should be monitored. Vitamins D, E, K (coagulation parameters), and folic acid levels should be monitored. The most frequently occurring adverse reactions in a short-term study with sevelamer carbonate tablets were nausea and vomiting. In a short-term study of sevelamer carbonate powder dosed three times daily, adverse events were similar to those reported for sevelamer carbonate tablets. In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included: vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation. Cases of fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation have been reported. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renvela. Patients should be informed to take Renvela with meals and to adhere to their prescribed diets. Please see full Prescribing Information at www.renvela.com
Renagel® (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with CKD on dialysis. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation or major GI tract surgery. Common adverse events reported with Renagel include vomiting, nausea, diarrhea, dyspepsia, abdominal pain, and constipation. Other events reported include pruritus, rash, fecal impaction, and intestinal obstruction. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renagel. Patients should be informed to take Renagel with meals and to adhere to their prescribed diets. Please see full Prescribing Information at www.renagel.com
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
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