"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same.
Renvela (sevelamer carbonate) is known chemically as poly(allylamine-co-N,N'-diallyl199 1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.
Figure 1: Chemical Structure of Sevelamer Carbonate
a, b = number of primary amine groups a + b = 9
c = number of crosslinking groups c = 1
m = large number to indicate extended polymer network
Renvela ® Tablets: Each film-coated tablet of Renvela contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglycerides, microcrystalline cellulose, sodium chloride and zinc stearate. The tablet imprint contains iron oxide black ink.
Renvela ® Powder: Each packet of Renvela Powder contains 0.8 g or 2.4 g of sevelamer carbonate on an anhydrous basis. The inactive ingredients are natural and artificial citrus flavor, propylene glycol alginate, sodium chloride, sucralose, and ferric oxide (yellow).
What are the possible side effects of sevelamer (Renagel, Renvela)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using sevelamer and call your doctor at once if you have a serious side effect such as:
- black, bloody, or tarry stools;
- constipation that gets worse or does not clear up;
- severe constipation with stomach pain; or
- fever, chills, body aches, flu symptoms.
Less serious side effects may include:
- nausea, vomiting, stomach pain, loss of appetite;
What are the precautions when taking sevelamer carbonate (Renvela)?
Before taking sevelamer, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood phosphorus levels, stomach/intestinal problems (such as blockage, constipation), stomach/intestinal surgeries, swallowing problems (dysphagia).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits...
Last reviewed on RxList: 8/3/2011
This monograph has been modified to include the generic and brand name in many instances.
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