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.

You should not take sevelamer if you have a bowel obstruction.

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 sevelamer in larger or smaller amounts or for longer than recommended.

Take sevelamer with meals.

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. Stir and drink this mixture right away. To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

While using sevelamer, 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.

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.

Usual Adult Dose for Hyperphosphatemia of Renal Failure:

Initial Dosing for patients not on a phosphate binder: 800 mg to 1600 mg orally 3 times a day with meals
Based on serum phosphorus level:
-Phosphorus greater than 5.5 to less than 7.5 mg/dL: 800 mg 3 times a day with meals
-Phosphorus greater than or equal to 7.5 mg/dL: 1600 mg 3 times a day with meals
-Titrate in increments of 800 mg 3 times a day at 2-week intervals with the goal of controlling serum phosphorus within target range.
Average prescribed dose: 7.2 g/day (2.4 g with each meal)
Maximum studied dose: 14 g per day (carbonate); 13 g per day (hydrochloride)

Switching from the hydrochloride salt to carbonate: Use the same dose, however further titration may be necessary to achieve desired phosphorus levels.

Switching from calcium acetate: Substitute approximately mg for mg

Comment: Treatment of hyperphosphatemia includes reduction in dietary intake of phosphate, inhibition of intestinal phosphate absorption with phosphate binders, and removal of phosphate with dialysis.

Use: To control serum phosphorus levels in patients with chronic kidney disease on dialysis.

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

To make sure sevelamer 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 this medicine 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 sevelamer 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.

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

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.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Your doctor may instruct you to follow a low-phosphorus diet. Follow these directions carefully. Talk to your doctor about foods that contain high amounts of phosphorus.

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.

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

Sevelamer may cause serious side effects. Stop using sevelamer and call your doctor at once if you have:

• choking, or trouble swallowing;

• black, bloody, or tarry stools;

• severe constipation with stomach pain; or

• constipation that gets worse or does not clear up.

Common side effects of sevelamer may include:

• nausea, vomiting, stomach pain, loss of appetite;

• upset stomach, gas, bloating;

• diarrhea, 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to determine your response to sevelamer.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.