Sevelamer
DRUG STATUS
Approvals
US(FDA), UK(BNF)
Essential Medicine
NO
Teratogenicity
Unlisted
Pharmaceutical Class
Phosphate Binder
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Sevelamer
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Click HereSummary
Sevelamer is primarily used to treat high phosphate levels (hyperphosphatemia) in patients with chronic kidney disease, especially those on dialysis. It's also used to manage phosphate levels in individuals at risk of calcium-phosphate imbalance and related complications like vascular calcification and bone disease.
Sevelamer works by binding to phosphate in your digestive tract, preventing its absorption into your bloodstream. This helps lower your phosphate levels, which is important if you have chronic kidney disease and your kidneys can't efficiently remove excess phosphate.
The typical daily dosage of Sevelamer for adults ranges from 800 mg to 1600 mg, taken with meals. It's important to take Sevelamer exactly as prescribed, with food, and avoid crushing or chewing the tablets. The prescribed dose may be divided into multiple doses throughout the day.
The most common side effects of Sevelamer include gastrointestinal issues like nausea, vomiting, diarrhea, and constipation. It can also cause abdominal discomfort, indigestion, and in rare cases, low calcium levels leading to symptoms like muscle cramps or irregular heartbeat.
It's important to monitor for gastrointestinal issues and low calcium levels when taking Sevelamer. The drug should be used cautiously in individuals with a history of bowel obstruction or severe gastrointestinal disorders. It's contraindicated in patients with bowel perforation or hypersensitivity to Sevelamer.
Indications and Purpose
What is Sevelamer used for?
Sevelamer is primarily indicated for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with chronic kidney disease (CKD), particularly those on dialysis. It is also used to manage phosphate levels in individuals who are at risk of calcium-phosphate imbalance and related complications such as vascular calcification and bone disease associated with CKD.
How does Sevelamer work?
Sevelamer works by binding to phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream. This helps to lower serum phosphate levels, which is important in patients with chronic kidney disease (CKD), as their kidneys cannot efficiently remove excess phosphate. By controlling phosphate levels, Sevelamer helps reduce the risk of bone disease, vascular calcification, and other complications associated with hyperphosphatemia in CKD patients.
Is Sevelamer effective?
Clinical studies have shown that Sevelamer is effective in lowering serum phosphate levels in patients with chronic kidney disease (CKD), especially those undergoing dialysis. Trials demonstrated that Sevelamer significantly reduced phosphate levels and helped maintain them within the target range, leading to a reduction in complications such as vascular calcification and bone disease. It has been proven to be at least as effective as other phosphate binders, such as calcium-based binders, without increasing the risk of hypercalcemia.
How does one know if Sevelamer is working?
The benefit of Sevelamer is primarily evaluated by monitoring serum phosphate levels in patients with chronic kidney disease (CKD). Regular blood tests are done to ensure phosphate levels are kept within the target range. Additionally, healthcare providers assess for improvements in complications such as bone health and vascular calcification through imaging or laboratory markers, ensuring that Sevelamer is effectively managing hyperphosphatemia.
Directions for Use
What is the usual dose of Sevelamer?
The average adult takes about 7.2 grams of this medication each day. For children 6 and up, the starting dose is 0.8 to 1.6 grams three times a day with meals. The dose is adjusted based on the child's body size. The highest dose studied in adults was 14 grams.
How do I take Sevelamer?
Sevelamer should be taken with meals to help reduce phosphate absorption. It is important not to chew or crush the tablets, as they need to be swallowed whole. There are no specific food restrictions while taking Sevelamer, but it should be used in combination with a phosphate-controlled diet as advised by your healthcare provider. Always follow the dosing instructions provided by your doctor.
For how long do I take Sevelamer?
The typical duration of use for sevelamer varies based on the patient's condition. Clinical studies have assessed its effectiveness over periods ranging from 8 weeks to 52 weeks. Long-term use may be necessary for chronic management, especially in patients with chronic kidney disease to control hyperphosphatemia. Regular monitoring and dose adjustments are recommended throughout the treatment period.
How long does it take for Sevelamer to start working?
Sevelamer starts working relatively quickly, with its effects on phosphate levels becoming noticeable within 1 to 2 weeks of starting treatment. However, it may take several weeks for the full benefit to be seen, depending on individual response and phosphate levels. Regular monitoring by a healthcare provider is necessary to adjust the dosage for optimal results.
How should I store Sevelamer?
Sevelamer should be stored at room temperature, between 68°F and 77°F (20°C to 25°C). Keep it in a tightly closed container to protect it from moisture and light. Do not store Sevelamer in the bathroom or kitchen, where humidity levels are high. Ensure the medication is kept out of reach of children.
Warnings and Precautions
Who should avoid taking Sevelamer?
Important warnings for Sevelamer include the potential for gastrointestinal issues such as nausea and constipation, which can be bothersome. It is also crucial to monitor calcium levels, as Sevelamer can lead to hypocalcemia in some patients. Sevelamer should be used cautiously in individuals with a history of bowel obstruction or severe gastrointestinal disorders. The drug is contraindicated in patients with bowel perforation or hypersensitivity to Sevelamer.
Can I take Sevelamer with other prescription drugs?
Sevelamer can interact with several prescription drugs, including levothyroxine, phenytoin, and warfarin. It may reduce the absorption and effectiveness of levothyroxine (thyroid hormone), phenytoin (anticonvulsant), and warfarin (anticoagulant), potentially leading to suboptimal therapeutic effects. To minimize these interactions, these medications should be taken at least 1 hour before or 3 hours after Sevelamer. Regular monitoring of drug levels is advised when using these medications together.
Can I take Sevelamer with vitamins or supplements?
Sevelamer can interfere with the absorption of certain fat-soluble vitamins (A, D, E, K) and folic acid. Long-term use may require monitoring and supplementation of these vitamins to prevent deficiencies. Additionally, Sevelamer may reduce the effectiveness of vitamin D supplements, so healthcare providers might adjust dosages or recommend regular vitamin monitoring. It's important to take vitamin supplements separately from Sevelamer to optimize absorption.
Can Sevelamer be taken safely while pregnant?
Sevelamer is classified as Category C for pregnancy by the FDA, which means there is limited evidence of safety in pregnant women. Animal studies have shown no direct fetal harm, but there are no well-controlled studies in humans. It should only be used during pregnancy if the potential benefits outweigh the risks, and it is important to consult a healthcare provider before use.
Can Sevelamer be taken safely while breastfeeding?
There is limited information available on the safety of Sevelamer during breastfeeding. It is not known whether Sevelamer passes into breast milk. However, it is generally considered safe to use during lactation since it primarily works in the digestive tract and is not significantly absorbed into the bloodstream. It is advisable to consult a healthcare provider before using Sevelamer while breastfeeding.
Is Sevelamer safe for the elderly?
- Lower Doses: Elderly patients may require lower doses to achieve effective phosphate control due to increased sensitivity.
- Monitoring: Careful monitoring is essential to prevent hypophosphatemia, as older adults are at higher risk.
- No Specific Limitations: Studies have not identified geriatric-specific problems that would limit sevelamer's usefulness in this population.
Is it safe to exercise while taking Sevelamer?
Exercise is safe while taking Sevelamer, but be cautious if you experience any gastrointestinal discomfort. Stay hydrated and consult your doctor if you feel unwell during exercise.
Is it safe to drink alcohol while taking Sevelamer?
There are no known significant interactions between Sevelamer and alcohol. However, drinking excessively can worsen gastrointestinal side effects like nausea. It's best to consume alcohol in moderation.