Renagel

Name: Renagel

What side effects can this medication cause?

Sevelamer may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea
  • vomiting
  • nausea
  • stomach pain
  • gas
  • heartburn
  • new or worsening constipation

Sevelamer may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Patient information

Dosing Recommendations

The prescriber should inform patients to take Renagel with meals and adhere to their prescribed diets. Instructions should be given on concomitant medications that should be dosed apart from Renagel.

Adverse Reactions

Renagel may cause constipation that if left untreated, may lead to severe complications. Patients should be cautioned to report new onset or worsening of existing constipation promptly to their physician.

What happens if i miss a dose (renagel, renvela)?

Take the missed dose as soon as you remember. Be sure to take the missed dose with food. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should i avoid while taking sevelamer (renagel, renvela)?

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.

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.

  • Kidney Failure

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sevelamer in the pediatric population. Safety and efficacy have not been established.

RenaGel Drug Class

RenaGel is part of the drug class:

  • Drugs for treatment of hyperkalemia and hyperphosphatemia

RenaGel Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • ciprofloxacin (Cipro)
  • levothyroxine

This is not a complete list of RenaGel drug interactions. Ask your doctor or pharmacist for more information.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sevelamer?

You may be taking other medicines that should not be taken at the same time. Taking sevelamer can make it harder for your body to absorb certain drugs, making them less effective:

  • ciprofloxacin (Cipro) should be taken at least 2 hours before or 6 hours after you take sevelamer;

  • mycophenolate mofetil (CellCept) should be taken at least 2 hours before you take sevelamer.

What other drugs will affect sevelamer?

Other drugs may interact with sevelamer, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Drug interactions

There are no empirical data on avoiding drug interactions between Renagel® and most concomitant oral drugs. For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology (12.3)]. The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product. Where possible consider monitoring clinical responses and/or blood levels of concomitant drugs that have a narrow therapeutic range.

Table 4. Sevelamer Drug Interactions
Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly
Digoxin
Enalapril
Iron
Metoprolol
Warfarin
Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from Renagel
Dosing Recommendations
Ciprofloxacin Take at least 2 hours before or 6 hours after sevelamer
Mycophenolate mofetil Take at least 2 hours before sevelamer

During postmarketing experience, cases of increased phosphate levels have been reported in patients taking proton pump inhibitors co-administered with sevelamer hydrochloride.

What is Renagel?

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

Renagel is used to control phosphorus levels in people with chronic kidney disease who are on dialysis.

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

Before taking this medicine

You should not take Renagel if you are allergic to sevelamer, or if you have a bowel obstruction.

To make sure Renagel is safe for you, tell your doctor if you have:

  • trouble swallowing;

  • severe constipation;

  • a blockage in your intestines;

  • slow digestion;

  • a stomach or intestinal disorder; or

  • if you have recently had stomach or intestinal surgery.

It is not known whether Renagel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Your dose needs may be different during pregnancy.

Taking Renagel while you are pregnant can lower your blood levels of certain vitamins or folic acid. Follow your doctor's instructions about taking vitamins or mineral supplements during pregnancy.

Because sevelamer is not absorbed into the bloodstream, it is not expected to be harmful to a nursing baby.

Renagel is not approved for use by anyone younger than 6 years old.

How should I take Renagel?

Take Renagel exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take Renagel tablets with meals.

While using Renagel, you may need frequent blood tests.

Call your doctor if you have have trouble swallowing the tablet, or if it feels like it gets stuck in your esophagus after you swallow it.

Renagel may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Be sure to take the missed dose with food. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

For the Consumer

Applies to sevelamer: oral capsule, oral powder for suspension, oral tablet

Along with its needed effects, sevelamer (the active ingredient contained in Renagel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sevelamer:

Incidence not known
  • Bloody, black, or tarry stools
  • heartburn
  • indigestion
  • nausea
  • severe abdominal or stomach pain, cramping, or burning
  • severe constipation
  • severe vomiting
  • trouble with breathing
  • vomiting
  • vomiting of material that looks like coffee grounds, severe and continuing

Some side effects of sevelamer may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • bloating
  • constipation
  • diarrhea
  • excess air or gas in the stomach or intestines
  • full feeling
  • passing gas
  • stomach discomfort or upset
Incidence not known
  • Itching skin
  • rash

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