How does this medication work? What will it do for me?
Sevelamer hydrochloride belongs to the class of medications called phosphate binders. Phosphate is made up mostly of the mineral phosphorus, which is an important component of normal bone structure, cell metabolism, and cell function.
In the body, the kidneys help keep the amount of phosphorus in the blood at a relatively constant level. For people with kidney problems, as their kidney function decreases, less phosphorus is removed from the body, potentially leading to a condition known as hyperphosphatemia (high phosphate levels in the blood). High levels of phosphorus in the blood can lead to problems with the strength and structure of bones. This condition is known as renal osteodystrophy.
When taken with meals, sevelamer hydrochloride prevents the absorption of phosphates from food by binding to the phosphate. It is used specifically to control high levels of phosphate (and therefore phosphorus) in the blood of people with severe kidney disease known as end stage renal disease (ESRD) who are receiving dialysis (hemodialysis or peritoneal dialysis).
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each oval, film-coated tablet, imprinted with "RENAGEL 800", on the crown, single side, contains 800 mg of sevelamer HCl. Nonmedicinal ingredients: colloidal silicon dioxide and stearic acid; coating: diacetylated monoglyceride and hypromellose; printing ink: hypromellose (hydroxypropyl methylcellulose), iron oxide black (E172), isopropyl alcohol, and propylene glycol.
How should I use this medication?
The dose of sevelamer hydrochloride depends on the amount of phosphorus that is present in the blood. The starting dose can range from 2.4 g to 4.8 g each day. Total daily doses of sevelamer hydrochloride are usually divided according to meal sizes, where higher doses of sevelamer hydrochloride are given with larger meals.
Your doctor may gradually increase the total daily dose of sevelamer hydrochloride according to the phosphorus level in your blood. Tablets should be taken immediately before meals or with meals. Swallow the tablets whole. Do not bite, chew, or break apart the tablet before swallowing.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of this medication, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take sevelamer hydrochloride if you:
- are allergic to sevelamer hydrochloride or any ingredients of the medication
- have a bowel obstruction
- have low levels of phosphorus in your blood
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- heartburn or indigestion
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.Check with your doctor as soon as possible if any of the following side effects occur:
- abdominal pain
- difficulty swallowing
- signs of inflammation in the digestive system (e.g., pain in the lower left abdomen, fever, nausea, diarrhea or constipation)
- signs of lower levels of calcium (e.g., muscle cramps, pain, dry skin)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of an allergic reaction (shortness of breath or difficulty breathing; hives; swelling of the eyes, mouth, lips, or throat)
- signs of a blockage in the digestive system (e.g., abdominal cramping, gas pain, nausea, vomiting after meals, excessive burping)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Gastrointestinal disorders: If you have gastrointestinal disorders (e.g., dysphagia [difficulty swallowing], severe disorders of movement in the gastrointestinal tract [i.e., the esophagus, stomach, and bowel]) or you have had major gastrointestinal surgery, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Low calcium: People with kidney disease may develop a condition called hypocalcemia (low calcium levels in the blood). While you are taking this medication, your doctor will regularly monitor your blood calcium levels. If you experience signs or symptoms of low blood calcium levels, such as muscle cramping or ache, dry skin or a feeling of pins and needles in your fingers, lips, tongue or feet, contact your doctor as soon as possible.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if sevelamer hydrochloride passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children and adolescents: The safety and effectiveness of using this medication have not been established for children and adolescents less than 18 years of age.
What other drugs could interact with this medication?
There may be an interaction between sevelamer hydrochloride and any of the following:
- medication for an irregular heartbeat (antiarrhythmics; e.g., amiodarone, propafenone)
- phosphate-containing medications or products
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- seizure medications (anticonvulsants; e.g., carbamazepine, phenytoin)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.