Sevelamer

Sevelamer comes as a tablet and as a powder 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.

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 oral 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.

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

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 oral suspension. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may tell you to take your medications at certain times before or after you take sevelamer, 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.Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• 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 or have ever had difficulty swallowing, gastrointestinal problems, such as 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.

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).

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.

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

Sevelamer may be found in some form under the following brand names:

• RenaGel

• Renvela

Sevelamer is part of the drug class:

• Drugs for treatment of hyperkalemia and hyperphosphatemia

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ciprofloxacin (Cipro)
• levothyroxine

This is not a complete list of sevelamer drug interactions. Ask your doctor or pharmacist for more information.

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.

Hyperphosphatemia

Reduction of serum phosphorus in patients with chronic kidney disease (CKD) who are undergoing dialysis.1 2 3 4 6 23

Risk of hypercalcemia is less than with calcium salts.2

Safety and efficacy not established in patients with CKD who are not undergoing dialysis.1 23

Contraindications

• Hypophosphatemia.1 23

• Bowel obstruction.1 23

Warnings/Precautions

General Precautions

Use with caution in patients with swallowing or severe GI motility disorders (including severe constipation), dysphagia, or major GI tract surgery.1 23 Provide appropriate treatment to patients who develop constipation or experience worsening of existing constipation to avoid the development of severe complications (e.g., fecal impaction, ileus, intestinal obstruction, intestinal perforation).1 23

Monitor patients on peritoneal dialysis for proper use of aseptic technique and for signs and symptoms of peritonitis.1 23

Sevelamer hydrochloride has decreased plasma concentrations of vitamins D, E, and K and folic acid in animals when given at doses 6–10 times the recommended human dosage.1 No evidence of decreased vitamin concentrations in some short-term studies of patients receiving sevelamer hydrochloride;1 2 5 23 however, a decrease in serum 25-hydroxy vitamin D3 concentrations from 39 to 34 mcg/mL (normal range: 10–55 mcg/mL) was reported in one 1-year study.1 Most patients (75%) in clinical studies of sevelamer hydrochloride have received vitamin supplements.1 23 Monitor for reduced serum concentrations of vitamin D, E, K (clotting factors) and folic acid.1

Monitor serum chloride and bicarbonate concentrations.1 22 23

Specific Populations

Category C.1 23

Requirements for vitamins and other nutrients are increased during pregnancy; the effect of sevelamer on vitamin and other nutrient absorption has not been studied in pregnant women.1 23

Caution is advised if used in nursing women.22

Safety and efficacy not established in children <18 years of age.1 2 3 4 22 23

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.1 23 (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Abdominal pain,1 23 constipation,1 23 diarrhea,1 2 3 4 23 dyspepsia,1 3 4 5 23 flatulence,1 23 nausea,1 2 3 4 23 peritonitis (in patients on peritoneal dialysis),1 23 vomiting.1 2 3 23

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sevelamer, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sevelamer or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sevelamer in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sevelamer in the elderly. However, elderly patients may start at a lower dose.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sevelamer, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using sevelamer with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ciprofloxacin
• Levothyroxine
• Mycophenolate Mofetil
• Mycophenolic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of sevelamer. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel blockage—Should not be used in patients with this condition.

• Difficulty with swallowing or other swallowing problems or
• Major surgery on the gastrointestinal tract or
• Stomach or bowel problems (e.g., constipation), severe—Use with caution. May cause serious side effects if the tablet cannot be swallowed completely and properly absorbed.

Sevelamer Carbonate Tablets, 800 mg are supplied as white to off-white, oval shaped, film-coated tablets, imprinted with “J 75” on one side with edible black ink and plain on other side, containing 800 mg of Sevelamer carbonate on an anhydrous basis, acetylated monoglycerides, ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, glyceryl behenate, hydroxypropyl cellulose, hypromellose, mannitol, propylene glycol, shellac glaze and talc.


               Bottles of 30               NDC 65862-921-30
               Bottles of 270             NDC 65862-921-27  

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight container. Protect from moisture.

NDC 65862-921-27
Sevelamer Carbonate
Tablets
800 mg
Rx only           270 Tablets
AUROBINDO

(se VEL a mer)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral, as carbonate:

Renvela: 0.8 g (1 ea, 90 ea); 2.4 g (1 ea, 90 ea) [citrus flavor]

Generic: 0.8 g (1 ea, 90 ea); 2.4 g (1 ea, 90 ea)

Tablet, Oral, as carbonate:

Renvela: 800 mg

Generic: 800 mg

Tablet, Oral, as hydrochloride:

Renagel: 400 mg, 800 mg

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling.

Calcitriol (Systemic): Sevelamer may decrease the serum concentration of Calcitriol (Systemic). Monitor therapy

Cholic Acid: Sevelamer may decrease the absorption of Cholic Acid. Management: Administer cholic acid at least 1 hour before or 4 to 6 hours after administration of any bile acid-binding products, such as sevelamer, to minimize the potential for a significant interaction. Consider therapy modification

CycloSPORINE (Systemic): Sevelamer may decrease the serum concentration of CycloSPORINE (Systemic). Monitor therapy

Levothyroxine: Sevelamer may decrease the serum concentration of Levothyroxine. Management: Consider separating administration of sevelamer and levothyroxine by at least several hours whenever possible in order to decrease the risk of a significant interaction. Consider therapy modification

Mycophenolate: Sevelamer may decrease the serum concentration of Mycophenolate. Management: Administer mycophenolate at least 2 hours prior to sevelamer administration. Consider therapy modification

Quinolone Antibiotics: Sevelamer may decrease the absorption of Quinolone Antibiotics. Management: Administer oral quinolones at least 2 hours before or 6 hours after sevelamer. Exceptions: LevoFLOXacin (Oral Inhalation). Consider therapy modification

Tacrolimus (Systemic): Sevelamer may decrease the serum concentration of Tacrolimus (Systemic). Monitor therapy

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.