Important Safety Information

• Do not use Renvela if you have a history of bowel obstruction. • 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. View additional Important Safety Information.

Glossary

Calcium
The most abundant mineral in the body. Calcium is an important part of your diet and, combined with phosphorus, keeps bones and teeth strong. Calcium also plays an important part in maintaining normal heart, nerve, and muscle function in the body.1
Cardiovascular
Having to do with the heart and the blood vessels.1
Chronic kidney disease (CKD)
The loss of kidney function over the course of a few years, often resulting in end stage renal disease (ESRD). People with ESRD have kidneys that no longer work, so they need dialysis or a transplant to do the work that their kidneys cannot do.2
Diabetes
A disease in which pancreas function is lost and insulin isn’t produced properly. This results in polyuria, which is the passage of a large amount of urine in a given period.1
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 two major forms of dialysis are hemodialysis and peritoneal dialysis.2
End Stage Renal Disease (ESRD)
Total chronic kidney failure. When the kidneys fail, the body retains fluids and harmful waste. A person with ESRD needs dialysis or a kidney transplant to take over the work of the failed kidneys.2
Glomerular filtration rate (GFR)
A measure of how well the kidneys are working.2
Hemodialysis
The removal of excess fluids and waste from the blood by a machine. This helps to replace the work of the kidneys after they have failed. Hemodialysis is the most common form of dialysis.2
High blood pressure
Also known as hypertension, high blood pressure can range from 140 mm Hg systolic and 90 mm Hg diastolic to as high as 200 mm Hg systolic and 110 mm Hg diastolic.1
Inherited and congenital conditions
Referring to conditions that are present at or before birth.1
Kidneys
Two bean-shaped organs that are responsible for filtering excess fluids and waste from the blood. The excess fluids and waste leave the body in the form of urine. The kidneys are also responsible for regulating the concentrations of hydrogen, sodium, potassium, and phosphorus in the body.1
Obesity
An increase in body weight beyond one’s physical limitations as a result of excessive accumulation of fat in the body.1
Parathyroid glands
Small bodies near the posterior surface of the thyroid gland. The parathyroid glands secrete a hormone that regulates the metabolism of calcium and phosphorus.1
Parathyroid hormone (PTH)
A hormone secreted by the parathyroid glands. It indirectly promotes increased absorption of calcium.1
Peritoneal dialysis
A process that uses dialysate and the membrane of the patient’s abdominal cavity to clean wastes and extra fluid from the blood.2
Phosphate binders
A substance that binds phosphorus in the blood, removing it from circulation. It is used to treat hyperphosphatemia, as in patients with end stage renal disease or hypoparathyroidism.1
Phosphorus
An essential dietary element that plays a critical role in maintaining healthy bones. It is abundant in all tissues and is an important component in almost all metabolic processes.1
Sevelamer
The active ingredient of Renvela® (sevelamer carbonate). A non-calcium, non-metallic phosphate binder that is used to reduce levels of serum phosphorus in the body.1,3

Indication

Renvela is used to control phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

Important Safety Information

  • Do not use Renvela if you have a history of bowel obstruction.
  • 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 frequently occurring side effects observed with Renvela tablets include nausea and vomiting.
  • Side effects with Renvela powder taken three times a day are similar to those reported for Renvela tablets
  • The most common side effects with Renagel, which contains the same active ingredient as Renvela, include vomiting, nausea, diarrhea, indigestion, abdominal pain, flatulence, and constipation.
  • Cases of itching, rash, fecal impaction and, less commonly, slow bowel activity, bowel obstruction, and bowel perforation have been reported.
  • Uncommon cases of difficulty swallowing the Renvela tablet have been reported. Talk to your doctor if you have difficulty swallowing medicines in tablet form. Renvela 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, K (clotting factors), and folic acid blood levels may be followed by your doctor.
  • Talk to your doctor when taking Renvela with other medications.
  • Promptly contact your doctor if you experience severe abdominal pain, new or worsening constipation, or other severe intestinal symptoms while on Renvela.
  • Take Renvela with meals and adhere to your prescribed diet.

Please see full Prescribing Information (PDF).

References

  1. Dorland's Illustrated Medical Dictionary. 31st ed. Philadelphia, PA: Saunders Elsevier; 2007. 2. The kidney disease dictionary. American Kidney Fund. http://www.kidneyfund.org. Updated December 18, 2007. Accessed April 21, 2011. 3. Renvela [package insert]. Cambridge, MA: Genzyme Corp; 2010.