sevelamer

Pronunciation

Generic Name: sevelamer (se VEL a mer)
Brand Name: Renagel, Renvela

What is sevelamer?

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

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

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

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

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

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

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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.

What should I discuss with my healthcare provider before taking sevelamer?

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

To make sure you can safely take sevelamer, tell your doctor if you have any of these other conditions:

  • trouble swallowing;

  • severe constipation;

  • a blockage in your intestines;

  • a stomach or intestinal disorder; or

  • if you have recently had stomach or intestinal surgery.

FDA pregnancy category C. It is not known whether sevelamer will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether sevelamer passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sevelamer?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take sevelamer with meals.

Do not crush, chew, or break the sevelamer tablet. Swallow the pill whole. Sevelamer tablets expand when they are wet, and breaking or crushing the pill may make it harder to swallow.

Sevelamer powder must be dissolved in water before you take it. The 0.8-gram packet should be mixed with at least 1 ounce (2 tablespoons) of water. The 2.4-gram packet should be mixed with at least 2 ounces (4 tablespoons) of water.

Stir the powder in water until it is completely dissolved. Drink all of this mixture right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Sevelamer 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.

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?

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.

Sevelamer side effects

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;

  • upset stomach, gas, bloating;

  • diarrhea, mild constipation;

  • tired feeling;

  • itching; or

  • joint pain.

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.

See also: Side effects (in more detail)

Sevelamer dosing information

Usual Adult Dose for Hyperphosphatemia of Renal Failure:

Initial:
Dialysis patients not taking a phosphate binder:

Sevelamer carbonate:
800 mg to 1600 mg orally three times daily with each meal based on serum phosphorus level:
Phosphorus greater than 5.5 and less than 7.5 mg/dL = 800 mg
Phosphorus greater than or equal to 7.5 and less than 9.0 mg/dL = 1600 mg
Phosphorus greater than or equal to 9.0 mg/dL = 1600 mg

Sevelamer hydrochloride: Renagel(R):
Phosphorus greater than 5.5 and less than 7.5 mg/dL = One 800 mg tablet or two 400 mg tablets orally 3 times daily with meals
Phosphorus greater than or equal to 7.5 and less than 9.0 mg/dL = Two 800 mg tablets or three 400 mg tablets orally 3 times daily with meals
Phosphorus greater than or equal to 9.0 mg/dL = Two 800 mg tablets or four 400 mg tablets orally 3 times daily with meals

Patients switching from calcium acetate to sevelamer:

Sevelamer carbonate: For each calcium acetate 667 mg tablet used per meal, give sevelamer carbonate 800 mg per meal.

Sevelamer hydrochloride: Renagel(R):
One calcium acetate 667 mg tablet per meal: Substitute one sevelamer hydrochloride 800 mg or two sevelamer hydrochloride 400 mg tablets per meal.
Two calcium acetate 667 tablets mg per meal: Substitute two sevelamer hydrochloride 800 mg or three sevelamer hydrochloride 400 mg tablets per meal.
Three calcium acetate 667 tablets mg per meal: Substitute three sevelamer hydrochloride 800 mg or five sevelamer hydrochloride 400 mg tablets per meal.

Patients switching from sevelamer hydrochloride to sevelamer carbonate: Dosage should be prescribed on a gram per gram basis.

Maximum daily dose studied for sevelamer hydrochloride is 13,000 mg and for carbonate is 14,000 mg.

Usual Pediatric Dose for Hyperphosphatemia of Renal Failure:

In a small pilot study of 17 pediatric patients aged 11.8 plus or minus 3.7 years on hemodialysis (n=3) or peritoneal dialysis (n=14), initial doses of 121 plus or minus 50 mg/kg/day (4.5 plus or minus 5 g/day) were used. Doses were adjusted based on the serum phosphorus with final doses of 163 plus or minus 46 mg/kg (6.7 plus or minus 2.4 gm/day) without any adverse effects (Mahdavi, 2003). In a study of 18 patients aged 0.9 to 18 years with chronic kidney disease, a mean dose of 140 plus or minus 86 mg/kg/day (5.38 plus or minus 3.24 g/day) resulted in good phosphorus control with minimal adverse effects. Initial doses were based on prior phosphate binder dose and were adjusted based on the serum phosphorus (Pieper, 2006).

What other drugs will affect sevelamer?

Tell your doctor about all other medicines you use, especially:

  • ciprofloxacin (Cipro);

  • levothyroxine (Synthroid, Levothroid, Levoxyl);

  • a heart rhythm medication; or

  • a seizure medication.

This list is not complete and other drugs may interact with sevelamer. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about sevelamer.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.02. Revision Date: 2012-07-27, 10:08:48 AM.

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