Description
Sevelamer is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with chronic kidney disease who are on dialysis.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Suspension
- Tablet
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 Renagel® in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Renvela® in children 6 years of age and older. Safety and efficacy have not been established in children younger than 6 years of age.
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.
Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Drug Interactions
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 this medicine, 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 this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Erdafitinib
- Mycophenolate Mofetil
- Mycophenolic Acid
- Vadadustat
Using this medicine 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
- Liothyronine
- Tecovirimat
Other Interactions
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 this medicine. 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 (eg, constipation), severe—Use with caution. May cause serious side effects if the tablet cannot be swallowed completely and properly absorbed.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Take this medicine with meals.
Follow carefully any diet program your doctor may recommend.
To use the oral liquid:
- Pour the entire contents of the packet in an empty cup.
- Mix the powder with 2 tablespoons of water for the 0.4-gram dose or the 0.8-gram dose or 4 tablespoons of water for the 2.4-gram dose.
- Stir the mixture vigorously and drink it as soon as you can or within 30 minutes. Be sure to stir the mixture again before drinking if you decide to wait.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
If you are taking any other medicines, you may be asked to take them at least 1 hour before or 3 hours after you take sevelamer. If you need help deciding the best times to take your other medicines, ask your doctor or pharmacist.
Take ciprofloxacin at least 2 hours before or 6 hours after this medicine.
Take mycophenolate mofetil at least 2 hours before this medicine.
Your doctor may tell you to take vitamins D, E, and K and folic acid supplements during treatment with this medicine, especially if you are pregnant.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For high phosphorus levels in the blood:
- For oral dosage forms (suspension or tablets):
- For patients not taking a phosphate binder:
- Renagel®:
- Adults—At first, 800 to 1600 milligrams (mg) (1 to 2 tablets) three times a day with meals, depending on your blood phosphorus level. Your doctor will adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Renvela®:
- Adults—At first, 800 to 1600 mg (1 to 2 tablets) or 0.8 to 1.6 grams (g) of powder for suspension three times a day with meals depending on your blood phosphorus level. Your doctor will adjust your dose as needed.
- Children 6 years of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor:
- 1.2 square meter (m2) or more of BSA—At first, 1.6 g of powder for suspension three times a day with meals depending on your blood phosphorus level. Your doctor will adjust your dose as needed.
- 0.75 to less than 1.2 m2 of BSA—At first, 0.8 g of powder for suspension three times a day with meals depending on your blood phosphorus level. Your doctor will adjust your dose as needed.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- Renagel®:
- For patients switching from Renagel® tablets to Renvela® powder for suspension or tablets:
- Adults—Use the same dose in grams. Your doctor will adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For patients switching from calcium acetate to sevelamer, your doctor will determine the best dose for you and adjust as needed.
- For patients not taking a phosphate binder:
- For oral dosage forms (suspension or tablets):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
If your symptoms do not improve or if they get worse, call your doctor.
This medicine may cause serious stomach or bowel problems, including blockage, bleeding, ulcers, colitis (severe diarrhea), necrosis, or perforation (tear or hole). Check with your doctor right away if you have bloating, bloody, black, or tarry stools, constipation, diarrhea, fever, heartburn, indigestion, nausea and vomiting, stomach pain, cramping, burning, or tenderness, or vomiting of material that looks like coffee grounds.
Many people with kidney problems need to be on a special diet. To keep your kidney disease from getting worse, it is very important that you follow your special diet and take your medicines regularly, even if you are feeling better.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Bloating
- bloody, black, or tarry stools
- constipation
- diarrhea
- fast heartbeat
- fever
- heartburn
- hives, itching, rash
- hoarseness
- indigestion
- irritation
- joint pain, stiffness, or swelling
- nausea or vomiting
- redness of the skin
- stomach pain, cramping, burning, or tenderness
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- troubled breathing or swallowing
- vomiting of material that looks like coffee grounds, severe and continuing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- belching
- excess air or gas in the stomach or intestines
- full feeling
- passing gas
- stomach discomfort or upset
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20065958
