Renvela

Renvela

What is Renvela?

Renvela is used to control phosphorus levels in dialysis patients with chronic kidney disease.

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

Warnings

You should not take Renvela if you have an intestinal blockage.

Before taking Renvela, tell your doctor if you have severe constipation, intestinal obstruction, stomach or intestinal disease, difficulty swallowing, or have recently had stomach or intestinal surgery.

Avoid taking other medicines within one hour before or three hours after taking Renvela. Sevelamer can bind to other medications and make them less effective.

Before taking this medication, 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 type of calcium or mineral supplements recommended by your doctor.

Before you take this medicine

You should not take Renvela if you are allergic to sevelamer or have an intestinal blockage.

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

• difficulty 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 planning to become pregnant. Your dosage needs may vary during pregnancy.

Taking Renvela during pregnancy may lower 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 breastfed baby.

Renvela is not approved for use by people under 6 years of age.

How should I take Renvela?

Take Renvela exactly as your doctor has told you. Follow all instructions on your prescription label. Your doctor may occasionally change your dose to ensure 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 taking. The 0.8 gram packet should be mixed with at least 2 tablespoons of water. The 2.4 gram packet should be mixed with at least 2 ounces (4 tablespoons) of water.

Stir the powder into water until completely dissolved. Stir and drink this mixture immediately. To get the full dose, add a little more water to the same glass, swirl gently, and drink immediately.

Frequent blood tests may be necessary while using sevelamer.

Call your doctor if you have trouble swallowingtabletor if you feel like it gets stuck in your esophagus after swallowing.

Renvela may only be part of a complete treatment program that also includes a special diet. It is very important that you follow the diet plan designed for you by your doctor or nutritionist. You should familiarize yourself with the list of foods you need to eat or avoid to control your condition.

Store at room temperature, protected from moisture and heat.

Dosage information

Usual Adult Dose for Hyperphosphatemia in Renal Failure:

Initial dosage for patients not taking a phosphate binder: 800 mg to 1600 mg orally three times daily with meals.
Based on serum phosphate levels:
-Phosphorus above 5.5 to below 7.5 mg/dl: 800 mg 3 times daily with meals
-Phosphorus greater than or equal to 7.5 to less than 9 mg/dL: 1200 to 1600 mg 3 times daily with meals
-Phosphorus greater than or equal to 9 mg/dl: 1600 mg 3 times daily with meals
– Titrate in 800 mg increments three times daily at 2-week intervals with the goal of maintaining serum phosphate levels within the target range.
Average prescribed dose: 7.2 g/day (2.4 g with each meal)
Maximum dose studied: 14 g per day (carbonate); 13 g per day (hydrochloride)

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

Switching from calcium acetate: Replace approximately mg with mg

Comment: Treatment of hyperphosphatemia includes reducing dietary phosphate intake, inhibiting intestinal phosphate absorption with phosphate binders, and removing phosphate by dialysis.

Use: To control serum phosphate levels in patients with chronic kidney disease requiring dialysis.

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 the next scheduled dose. Do not take extra medicine to make up for a missed dose.

What happens if I overdose?

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

What to avoid

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 medications, making them less effective:

• Ciprofloxacin (Cipro) should be taken at least 2 hours before or 6 hours after taking Renvela;

• Mycophenolate mofetil (CellCept) should be taken at least 2 hours before taking Renvela.

Side effects of Renvela

If necessary, get emergency medical helpSigns of an allergic reaction to Renvela: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Stop using Renvela and call your doctor immediately if you have:

• choking or difficulty swallowing;

• black, bloody, or tarry stools;

• severe constipation with stomach pain; or

• Constipation that gets worse or doesn't go away.

Common side effects of Renvela may include:

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

• stomach discomfort, bloating, flatulence;

• 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 can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Renvela?

Other medications may interact with Renvela, including prescription and over-the-counter medications, vitamins, and herbal products. Tell each of your healthcare providers about all medications you are taking now and any medications you are starting or stopping taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use them only for the prescribed indication.