Sevelamer 400mg Hcl Tablets
It is used to lower high phosphate levels.
Drug Class
Phosphate Binder
Pharmacologic Class
Anion Exchange Resin
Pregnancy Category
Category C
FDA Approved
Oct 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sevelamer is a medication used to lower high phosphorus levels in the blood, especially for people with kidney disease who are on dialysis. It works by binding to phosphorus in the food you eat, preventing your body from absorbing it. This helps keep your bones healthy and prevents other problems caused by too much phosphorus.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with meals to help your body absorb it properly. Swallow the tablets whole - do not chew, break, or crush them.
It's essential to note that this medication can interact with other drugs, preventing them from being absorbed by your body. If you're taking other medications, consult your doctor or pharmacist to determine if you need to take them at a different time than your current medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medications. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with meals to help your body absorb it properly. Swallow the tablets whole - do not chew, break, or crush them.
It's essential to note that this medication can interact with other drugs, preventing them from being absorbed by your body. If you're taking other medications, consult your doctor or pharmacist to determine if you need to take them at a different time than your current medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medications. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take sevelamer with meals. Do not skip doses.
- Swallow tablets whole; do not crush, chew, or break them, as this can affect how the medicine works.
- Follow your doctor's dietary recommendations, especially regarding phosphorus intake.
- Do not take other medications (especially thyroid hormones or certain antibiotics) at the same time as sevelamer. Ask your doctor or pharmacist about specific timing for other medications.
- Attend all scheduled lab tests to monitor your phosphorus, calcium, and vitamin levels.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 2-4 tablets (800-1600 mg) three times daily with meals, based on serum phosphate levels. Titrate by 2-4 tablets (800-1600 mg) three times daily every 2-4 weeks to achieve target serum phosphate levels.
Dose Range:
2400 - 13000 mg
Condition-Specific Dosing:
serum_phosphate_gt_6_0_mg_dL:
Initial dose: 2 tablets (800 mg) three times daily with meals.
serum_phosphate_gt_7_5_mg_dL:
Initial dose: 4 tablets (1600 mg) three times daily with meals.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 6 years of age or those who cannot swallow tablets. For older children, dosing is weight-based and typically uses powder for oral suspension.
Adolescent:
Not established for children under 6 years of age or those who cannot swallow tablets. For older children, dosing is weight-based and typically uses powder for oral suspension.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (used for this condition)
Moderate:
No adjustment needed (used for this condition)
Severe:
No adjustment needed (used for this condition)
Dialysis:
No adjustment needed (primary indication for use)
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Sevelamer is a non-absorbed phosphate binding polymer. It contains multiple amines separated by one carbon from the polymer backbone, which become protonated in the acidic environment of the stomach. These protonated amines bind to phosphate ions through ionic and hydrogen bonding, thereby preventing the absorption of dietary phosphate from the gastrointestinal tract and lowering serum phosphate concentrations.
Pharmacokinetics
Absorption:
Bioavailability:
Not absorbed systemically (<0.002%)
Tmax:
Not applicable (not absorbed)
FoodEffect:
Must be taken with meals to be effective in binding dietary phosphate.
Distribution:
Vd:
Not applicable (not absorbed)
ProteinBinding:
Not applicable (not absorbed)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (not absorbed)
Clearance:
Not applicable (not absorbed)
ExcretionRoute:
Fecal
Unchanged:
>99%
Pharmacodynamics
OnsetOfAction:
Within days (phosphate binding begins immediately upon ingestion)
PeakEffect:
Within 1-2 weeks (after dose titration to target)
DurationOfAction:
Continuous with regular dosing
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Black, tarry, or bloody stools
Vomiting blood or material that looks like coffee grounds
Difficulty swallowing
New or worsening constipation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Black, tarry, or bloody stools
Vomiting blood or material that looks like coffee grounds
Difficulty swallowing
New or worsening constipation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe constipation
- Severe abdominal pain
- New or worsening nausea or vomiting
- Difficulty swallowing
- Signs of bowel obstruction (e.g., severe bloating, inability to pass gas or stool)
- Unusual bleeding or bruising (may indicate vitamin K deficiency)
- Bone pain or muscle weakness (may indicate vitamin D deficiency)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a bowel blockage, as this may affect the use of this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you have, as they may interact with this medication.
To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other drugs and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a bowel blockage, as this may affect the use of this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you have, as they may interact with this medication.
To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other drugs and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
To minimize potential risks, it is crucial to follow the personalized diet plan recommended by your doctor. Be aware that this medication can cause severe stomach or bowel problems, including bowel obstruction, swelling, and perforation of the gastrointestinal (GI) tract. If you have any questions or concerns, consult with your doctor promptly.
Additionally, there is a risk of the tablet becoming lodged in your throat, which may require hospitalization and treatment. If you have a history of swallowing difficulties, inform your doctor to discuss possible alternatives.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to consult with your doctor to weigh the benefits and risks of this medication to both you and your baby.
To minimize potential risks, it is crucial to follow the personalized diet plan recommended by your doctor. Be aware that this medication can cause severe stomach or bowel problems, including bowel obstruction, swelling, and perforation of the gastrointestinal (GI) tract. If you have any questions or concerns, consult with your doctor promptly.
Additionally, there is a risk of the tablet becoming lodged in your throat, which may require hospitalization and treatment. If you have a history of swallowing difficulties, inform your doctor to discuss possible alternatives.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to consult with your doctor to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe constipation
- Bowel obstruction (rare, but possible with excessive doses or pre-existing GI issues)
What to Do:
Contact a poison control center or emergency medical services immediately. In the US, call 1-800-222-1222. Treatment is generally supportive, focusing on managing gastrointestinal symptoms.
Drug Interactions
Major Interactions
- Levothyroxine (reduced absorption, administer at least 4 hours before sevelamer)
- Ciprofloxacin (reduced absorption, administer at least 2 hours before sevelamer)
Moderate Interactions
- Mycophenolate mofetil (reduced absorption, monitor MMF levels)
- Fat-soluble vitamins (A, D, E, K) and Folic acid (reduced absorption, consider supplementation)
- Antiarrhythmic agents (e.g., amiodarone, quinidine) - potential for reduced absorption, monitor levels
Monitoring
Baseline Monitoring
Serum Phosphate
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Serum Calcium (corrected)
Rationale: To establish baseline and monitor for potential calcium imbalances.
Timing: Prior to initiation of therapy.
Serum Parathyroid Hormone (PTH)
Rationale: To assess bone mineral disease status and guide overall management.
Timing: Prior to initiation of therapy.
Serum Bicarbonate
Rationale: To assess for potential metabolic acidosis (though less common with HCl form than carbonate).
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Phosphate
Frequency: Every 2-4 weeks during dose titration, then monthly or as clinically indicated once stable.
Target: 2.5-4.5 mg/dL (KDOQI guidelines)
Action Threshold: Adjust dose if outside target range.
Serum Calcium (corrected)
Frequency: Monthly or as clinically indicated.
Target: 8.4-10.2 mg/dL
Action Threshold: Investigate and manage if persistently low or high.
Serum PTH
Frequency: Every 3-6 months or as clinically indicated.
Target: 2-9 times upper limit of normal for assay (KDOQI guidelines)
Action Threshold: Adjust therapy for bone mineral disease if outside target.
Serum Bicarbonate
Frequency: Periodically, as clinically indicated.
Target: 22-29 mEq/L
Action Threshold: Investigate and manage if persistently low.
Fat-soluble Vitamins (A, D, E, K) and Folic Acid
Frequency: Periodically (e.g., annually or as clinically indicated), especially if signs of deficiency.
Target: Normal range for age/sex
Action Threshold: Supplement if deficient.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
- Indigestion
- Signs of vitamin deficiency (e.g., fatigue, bone pain, bleeding, vision changes)
Special Patient Groups
Pregnancy
Category C. Sevelamer is not absorbed systemically, so maternal exposure is minimal. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Minimal systemic exposure, unlikely to cause direct teratogenic effects. Potential for vitamin deficiencies due to binding.
Second Trimester:
Minimal systemic exposure. Potential for vitamin deficiencies due to binding.
Third Trimester:
Minimal systemic exposure. Potential for vitamin deficiencies due to binding.
Lactation
L3 (Moderately Safe). Sevelamer is not absorbed systemically by the mother, so it is not expected to be excreted in breast milk. Therefore, direct infant exposure is unlikely. However, potential for maternal vitamin deficiencies could indirectly affect breast milk quality. Monitor infant for adequate growth and development.
Infant Risk:
Low risk of direct exposure. Monitor for signs of vitamin deficiency in the infant if maternal deficiency is suspected.
Pediatric Use
Safety and efficacy have not been established for children under 6 years of age or those who cannot swallow tablets. For older children, sevelamer carbonate powder for oral suspension is typically used, with dosing based on body surface area or weight. Close monitoring of growth and vitamin levels is crucial.
Geriatric Use
No specific dose adjustment is required based on age. Elderly patients may be more susceptible to constipation or other gastrointestinal side effects. Monitor for bowel habits and ensure adequate fluid intake.
Clinical Information
Clinical Pearls
- Sevelamer HCl is a non-calcium, non-aluminum phosphate binder, making it a good option for patients concerned about calcium overload or aluminum toxicity.
- It must be taken with meals to effectively bind dietary phosphate.
- Patients should be advised to swallow tablets whole to avoid issues with taste or efficacy.
- Regular monitoring of serum phosphate, calcium, and PTH is essential to guide dose adjustments.
- Consider supplementation of fat-soluble vitamins (A, D, E, K) and folic acid, as sevelamer can bind these in the GI tract.
- Counsel patients on potential GI side effects like constipation, nausea, and vomiting, and strategies to manage them (e.g., adequate fluid intake, fiber).
Alternative Therapies
- Sevelamer Carbonate (Renvela)
- Calcium Acetate (PhosLo)
- Calcium Carbonate (Tums, Caltrate)
- Lanthanum Carbonate (Fosrenol)
- Sucroferric Oxyhydroxide (Velphoro)
- Ferric Citrate (Auryxia)
Cost & Coverage
Average Cost:
$100 - $300 per 180 tablets (400mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand) for most prescription drug plans, often covered for CKD patients.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.