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

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

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

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

Before taking Renvela, 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.

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

Before taking this medicine, 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.

Before taking this medicine

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

To make sure Renvela 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 Renvela 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.

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

Take Renvela 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 Renvela with meals.

Renvela 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.

Renvela 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 to less than 9 mg/dL: 1200 to 1600 mg 3 times a day with meals
-Phosphorus greater than or equal to 9 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 Renvela if you are allergic to sevelamer, or if you have a bowel obstruction.

To make sure Renvela 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 Renvela 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.

Renvela 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.

You may be taking other medicines that should not be taken at the same time. Taking Renvela 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 Renvela;

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

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

Stop using Renvela 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 Renvela side effects 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 Renvela, 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.