Renvela

DRUG DESCRIPTION

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

Chemical Structure of Sevelamer Carbonate - Illustration

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; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe stomach pain or constipation; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • upset stomach;
  • stomach pain, gas;
  • nausea, vomiting;
  • diarrhea; or
  • ...

Read All Potential Side Effects and See Pictures of Renvela »

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: low blood phosphorus levels, bowel blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (e.g., constipation), stomach/intestinal surgeries, swallowing problems (dysphagia).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits...

Read All Potential Precautions of Renvela »


Renvela Consumer (continued)

SIDE EFFECTS: Headache, diarrhea, stomach upset, nausea, vomiting, cough, gas, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if these unlikely but serious side effects occur: problems with your dialysis access site, severe constipation/inability to have a bowel movement, stomach/abdominal pain or swelling.

Seek immediate medical attention if any of these rare but very serious side effects occur: trouble breathing, chest pain, pain/redness/swelling in the lower legs.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: low blood phosphorus levels, bowel blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (e.g., constipation), stomach/intestinal surgeries, swallowing problems (dysphagia).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Renvela Patient Information Including Side Effects

Brand Names: Renagel, Renvela

Generic Name: sevelamer (Pronunciation: se VEL a mer)

  • What is sevelamer (Renvela)?
  • What are the possible side effects of sevelamer (Renvela)?
  • What is the most important information I should know about sevelamer (Renvela)?
  • What should I discuss with my healthcare provider before taking sevelamer (Renvela)?
  • How should I take sevelamer (Renvela)?
  • What happens if I miss a dose (Renvela)?
  • What happens if I overdose (Renvela)?
  • What should I avoid while taking sevelamer (Renvela)?
  • What other drugs will affect sevelamer (Renvela)?
  • Where can I get more information?

What is sevelamer (Renvela)?

Sevelamer is a phosphate binder. Sevelamer helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.

Sevelamer is used to reduce blood levels of phosphorus in people with chronic kidney disease who are on dialysis.

Sevelamer may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sevelamer (Renvela)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe stomach pain or constipation; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • upset stomach;
  • stomach pain, gas;
  • nausea, vomiting;
  • diarrhea; or
  • constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sevelamer (Renvela)?

You should not take this medication if you are allergic to sevelamer, or if you have a low blood level of phosphorus (hypophosphatemia), or a blockage in your intestines.

Before taking sevelamer, tell your doctor if you have trouble swallowing, severe constipation, a digestive disorder of your stomach or intestines, or if you have recently had stomach or intestinal surgery.

Avoid taking any other medicines within 1 hour before or 3 hours after you take sevelamer. Sevelamer can bind to other medications and make them less effective.

Before taking sevelamer, tell your doctor if you are taking ciprofloxacin (Cipro), a heart rhythm medication, or a seizure medication.

Do not take calcium or other mineral supplements without your doctor's advice. Use only the specific type of calcium or mineral supplement your doctor recommends.

Related Drug Centers
  • Renvela
  • Renagel


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