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Renvela® (sevelamer carbonate) is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Important Safety Information
Do not use Renvela if you have a history of bowel obstruction or if you are allergic to sevelamer carbonate, sevelamer hydrochloride, or to any of the ingredients in Renvela.
Click here for additional Important Safety Information.
Please see Full Prescribing Information for Renvela (PDF).
Please see Full Prescribing Information for Sevelamer Carbonate (PDF).
Glossary
Blood pressure
The measure of pressure of the blood within your arteries. High blood pressure is when the force of the blood against your artery walls is high enough that it may lead to problems like heart disease.
Calcium
There is more calcium than any other mineral in the body. It is an important part of your diet, and works with phosphorus to keep bones and teeth strong. Calcium also plays a role in maintaining normal heart, nerve, and muscle function in the body.
Chronic kidney disease (CKD)
The loss of kidney function over the course of a few years. CKD Stage 5 is severely reduced kidney function, also called end-stage renal disease (ESRD). People with CKD Stage 5 need dialysis or a transplant to do the work that their kidneys can not.
Dialysis
The process of cleaning waste from the blood artificially. The kidneys normally do this job, but if they aren’t working, the blood must be cleaned with special equipment. The 2 major forms of dialysis are hemodialysis and peritoneal dialysis.
Hemodialysis
The removal of excess fluids and waste from the blood by a machine. This helps to do the work of the kidneys after they have failed. Hemodialysis is the most common form of dialysis and is generally done at a dialysis center.
Kidneys
Most people have two kidneys. These organs clean the excess fluid and waste from your blood. The excess fluids and waste then leave the body in the form of urine. The kidneys also regulate the amount of important chemicals and minerals in your body.
Metabolic
This refers to the many chemical processes related to metabolism. Metabolism consists of the buildup and breakdown of substances in the body.
Parathyroid hormone (PTH)
PTH plays an important role in the absorption of calcium in your body.
Peritoneal dialysis
A process that uses dialysate (a cleansing liquid) and the lining of the your abdominal cavity to clean waste and excess fluid from the blood. Peritoneal dialysis can be done at home.
Phosphate binders
A type of medicine that binds to phosphorus in your digestive system.
Phosphorus
A mineral that plays an important role in maintaining healthy bones. It is found in all tissues in your body and is an important part of metabolic processes in the body.
Sevelamer
The active ingredient of Renvela® (sevelamer carbonate). Sevelamer can help control phosphorus in your blood to help get your minerals in balance. It does not contain calcium or metal and is not absorbed, so it does not build up in your body.
Renvela®
Indication
Renvela® (sevelamer carbonate) is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Important Safety Information
- Do not use Renvela if you have a history of bowel obstruction or if you are allergic to sevelamer carbonate, sevelamer hydrochloride, or to any of the ingredients in Renvela.
- Talk to your doctor if you have had difficulty swallowing or swallowing disorders; or if you have had digestive tract surgery or other digestive disorders, including severe constipation.
- The most common side effects with sevelamer include vomiting, nausea, diarrhea, indigestion, abdominal pain, flatulence, and constipation.
- Cases of hypersensitivity, itching, rash, stomach pain, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, fecal impaction and less commonly, slow bowel activity, bowel obstruction, and bowel perforation have been reported.
- Cases of difficulty swallowing the Renvela tablet have been reported. Talk to your doctor if you have difficulty swallowing medicines in tablet form. Renvela powder for oral suspension may be considered by your doctor if you have a history of difficulty swallowing.
- Your doctor should monitor bicarbonate and chloride blood levels.
- Reduced vitamins D, E, and K (clotting factors) and folic acid blood levels may be followed by your doctor.
- Talk to your doctor when taking sevelamer with other medications.
- Promptly contact your doctor if you experience severe abdominal pain, new or worsening constipation, or other severe intestinal symptoms while on sevelamer.
- Take sevelamer with meals and adhere to your prescribed diet
Sevelamer Carbonate
Indication
Sevelamer carbonate is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Important Safety Information
- Do not use sevelamer carbonate if you have a history of bowel obstruction or if you are allergic to sevelamer carbonate, sevelamer hydrochloride or to any of the ingredients.
- Talk to your doctor if you have had difficulty swallowing or swallowing disorders; or if you have had digestive tract surgery or other digestive disorders, including severe constipation.
- The most common side effects with sevelamer include vomiting, nausea, diarrhea, indigestion, abdominal pain, flatulence, and constipation.
- Cases of itching, rash, fecal impaction and, less commonly, slow bowel activity, bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis and bowel perforation have been reported.
- Uncommon cases of difficulty swallowing the sevelamer carbonate tablet have been reported. Talk to your doctor if you have difficulty swallowing medicines in tablet form. Sevelamer carbonate for oral suspension may be considered by your doctor if you have a history of difficulty swallowing.
- Your doctor should monitor your bicarbonate and chloride blood levels.
- Reduced vitamins D, E, and K (clotting factors) and folic acid blood levels may be followed by your doctor.
- Talk to your doctor when taking sevelamer carbonate with other medications.
- Promptly contact your doctor if you experience severe abdominal pain, new or worsening constipation, or other severe intestinal symptoms while on sevelamer carbonate.
- Take sevelamer carbonate with meals and adhere to your prescribed diet.
Please see Full Prescribing Information for Renvela (PDF).
Please see Full Prescribing Information for Sevelamer Carbonate (PDF).
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