Renagel

DRUG DESCRIPTION

The active ingredient in Renagel Tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonated. It is known chemically as poly(allylamine-co-N,N'-diallyl 1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1.

Figure 1: Chemical Structure of Sevelamer Hydrochloride

Renagel (sevelamer hydrochloride) Structural Formula Illustration

The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin.

Renagel Tablets: Each film-coated tablet of Renagel contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. The tablet imprint contains iron oxide black ink.

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 Renagel

What are the precautions when taking sevelamer hcl (Renagel)?

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 Renagel


Renagel 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.


Renagel Patient Information Including Side Effects

Brand Names: Renagel, Renvela

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

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

What is sevelamer (Renagel)?

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 (Renagel)?

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 (Renagel)?

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.

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