Sevelamer

WHY is this medicine prescribed?

Sevelamer is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis (medical treatment to clean the blood when the kidneys are not working properly). Sevelamer is in a class of medications called phosphate binders. It binds phosphorus that you get from foods in your diet and prevents it from being absorbed into your blood stream.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Sevelamer comes as a tablet and as a powder for suspension to take by mouth. It is usually taken three times a day with meals. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sevelamer exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not break or crush the tablets.

Your doctor will probably adjust your dose based on your phosphorus blood levels, not more often than once every 2 weeks.

If you are taking the powder for suspension, carefully read the manufacturer's instructions for use that come with the medication. These instructions describe how to prepare and measure your dose. Mix the powder with the recommended amount of water for your dose and stir the mixture vigorously. The mixture will be cloudy as the powder does not dissolve. Alternatively, you can mix the powder with a food or beverage. Do not microwave the mixture or add the powder to heated foods or liquids. Take the mixture immediately after preparation (within 30 minutes), as part of your meal. If the mixture is not taken within 30 minutes of preparing it, dispose of the mixture.

What SPECIAL PRECAUTIONS should I follow?

Before taking sevelamer,

• tell your doctor and pharmacist if you are allergic to sevelamer, any other medications, or any of the ingredients in sevelamer tablets or powder for suspension. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking sevelamer. Your doctor may need to change the doses of your medications or monitor you carefully for side effects..

• if you are taking cyclosporine (Gengraf, Neoral, Sandimmune), levothyroxine (Levo-T, Synthroid, Tirosint, others), or tacrolimus (Astagraf, Prograf, Protopic), you should take them at least 1 hour before or 3 hours after you have taken sevelamer. Take ciprofloxacin (Cipro) at least 2 hours before or 6 hours after taking sevelamer. Also, take mycophenolate (Cellcept) at least 2 hours before taking sevelamer.

• tell your doctor if you have a blockage of your stomach or intestines. Your doctor will probably tell you not to take sevelamer.

• tell your doctor if you have difficulty swallowing, or have or have ever had stomach or bowel problems including ulcers (sores in the lining of the stomach or intestine), an inflammatory bowel disease, constipation, or have had surgery on your stomach or intestines.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking sevelamer, call your doctor.

• you should know that sevelamer may decrease levels of vitamins and folic acid in the body. Talk to your doctor to see if you need to take additional amount of these vitamins during your treatment with sevelamer.

What SPECIAL DIETARY instructions should I follow?

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.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine 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

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• black and tarry stools
• red blood in stools

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What OTHER INFORMATION should I know?

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.