Sevelamer 800mg Hcl Tablets
It is used to lower high phosphate levels.
Drug Class
Phosphate Binder
Pharmacologic Class
Non-calcium, Non-aluminum Phosphate Binder; 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 phosphate levels in the blood, especially for people with kidney disease who are on dialysis. It works by binding to phosphate in your food as it passes through your stomach and intestines, preventing your body from absorbing it. This helps keep your bones healthy and prevents other problems caused by too much phosphate.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Take your medication with meals to help your body absorb it properly. Swallow the tablet whole - do not chew, break, or crush it.
It's also important to note that this medication can interact with other medications, preventing them from being absorbed by your body. If you're taking other medications, consult with 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 get the full benefit of the treatment.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When it's time to dispose of your medication, don't flush it down the toilet or pour it down the drain unless you're instructed to do so. Instead, throw away any unused or expired medication. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any 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, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Take your medication with meals to help your body absorb it properly. Swallow the tablet whole - do not chew, break, or crush it.
It's also important to note that this medication can interact with other medications, preventing them from being absorbed by your body. If you're taking other medications, consult with 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 get the full benefit of the treatment.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When it's time to dispose of your medication, don't flush it down the toilet or pour it down the drain unless you're instructed to do so. Instead, throw away any unused or expired medication. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any 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. It will not work as well if taken at other times.
- Swallow tablets whole. Do not chew, crush, or break them.
- Follow your prescribed diet, which is usually low in phosphate. Sevelamer works best when combined with a proper diet.
- If you miss a dose, do not take a double dose. Take your next dose at the usual time with your next meal.
- Take other medications at least 1 hour before or 3 hours after sevelamer, or as advised by your doctor, to prevent interactions.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 800 mg or 1600 mg (1 or 2 tablets) three times daily with meals, titrate to achieve target serum phosphate levels.
Dose Range:
2400 - 13000 mg
Condition-Specific Dosing:
hyperphosphatemia_ckd_dialysis:
Initial dose based on current serum phosphate level: >5.5 to <7.5 mg/dL: 800 mg TID with meals; >=7.5 mg/dL: 1600 mg TID with meals. Adjust dose by 800 mg increments every 2-4 weeks until target phosphate level is reached. Max dose typically 13 g/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing is individualized based on body surface area (BSA) or weight and serum phosphate levels. Generally, 0.4 g/kg/day to 1.6 g/kg/day divided into 3 doses with meals. Safety and efficacy not fully established in pediatric patients.
Adolescent:
Dosing is individualized based on body surface area (BSA) or weight and serum phosphate levels. Generally, 0.4 g/kg/day to 1.6 g/kg/day divided into 3 doses with meals. Safety and efficacy not fully established in pediatric patients.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed, as it is used to treat hyperphosphatemia in patients on dialysis.
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 that contains multiple amines separated by one carbon from the polymer backbone. These amines become protonated in the acidic environment of the stomach and bind to phosphate ions through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract, sevelamer decreases phosphate absorption and lowers serum phosphate concentrations.
Pharmacokinetics
Absorption:
Bioavailability:
Not absorbed systemically
Tmax:
Not applicable (not absorbed)
FoodEffect:
Must be taken with meals to maximize phosphate binding
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:
100%
Pharmacodynamics
OnsetOfAction:
Immediate (phosphate binding in GI tract)
PeakEffect:
Days to weeks (on serum phosphate levels, with titration)
DurationOfAction:
Dependent on continued administration with meals
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 coffee ground-like material
Difficulty swallowing
New or worsening constipation
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
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 for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 coffee ground-like material
Difficulty swallowing
New or worsening constipation
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
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 for medical advice. 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 or new onset of constipation
- Severe abdominal pain
- Difficulty swallowing
- Choking sensation
- Signs of vitamin deficiency (unusual tiredness, easy bruising, bone pain, vision changes)
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) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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. This medication has been associated with 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.
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 promptly.
Before taking this medication, it is vital to discuss your pregnancy status or plans with your doctor. If you are pregnant, planning to become pregnant, or breastfeeding, you and your doctor will need 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. This medication has been associated with 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.
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 promptly.
Before taking this medication, it is vital to discuss your pregnancy status or plans with your doctor. If you are pregnant, planning to become pregnant, or breastfeeding, you and your doctor will need to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe constipation
- Abdominal distension
- Intestinal obstruction (rare)
What to Do:
There are no specific antidotes. Treatment is supportive. In case of suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Major Interactions
- Levothyroxine (reduced absorption of levothyroxine, administer at least 4 hours before sevelamer)
- Ciprofloxacin (reduced absorption of ciprofloxacin, administer at least 2 hours before sevelamer)
- Mycophenolate mofetil (reduced absorption of mycophenolate mofetil, monitor efficacy)
Moderate Interactions
- Fat-soluble vitamins (A, D, E, K - may reduce absorption, consider supplementation)
- Folic acid (may reduce absorption, consider supplementation)
- Warfarin (potential for reduced absorption, monitor INR closely)
- Antiarrhythmic agents (e.g., amiodarone, quinidine - potential for reduced absorption, monitor levels)
Monitoring
Baseline Monitoring
Serum Phosphate
Rationale: To establish baseline hyperphosphatemia and guide initial dosing.
Timing: Prior to initiation of therapy
Serum Calcium
Rationale: To assess calcium-phosphate balance and rule out hypocalcemia.
Timing: Prior to initiation of therapy
Serum Parathyroid Hormone (PTH)
Rationale: To assess bone mineral disease and guide overall management.
Timing: Prior to initiation of therapy
Serum Bicarbonate
Rationale: To assess for metabolic acidosis, as sevelamer HCl can potentially lower bicarbonate.
Timing: Prior to initiation of therapy
Vitamin D levels (25-hydroxyvitamin D)
Rationale: To assess vitamin D status, as sevelamer may reduce absorption of fat-soluble vitamins.
Timing: Prior to initiation of therapy
Routine Monitoring
Serum Phosphate
Frequency: Weekly or bi-weekly initially during titration, then monthly once stable
Target: 2.5-4.5 mg/dL (KDOQI target for CKD Stage 5D)
Action Threshold: Above target range: increase dose; Below target range: decrease dose or consider alternative
Serum Calcium
Frequency: Monthly
Target: 8.4-10.2 mg/dL (corrected for albumin)
Action Threshold: Hypocalcemia: investigate cause, consider calcium supplementation; Hypercalcemia: investigate cause, adjust other calcium-containing binders
Serum Bicarbonate
Frequency: Every 3-6 months
Target: 22-29 mEq/L
Action Threshold: Persistent acidosis: consider bicarbonate supplementation or alternative phosphate binder
Fat-soluble Vitamins (A, D, E, K) and Folic Acid
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Normal ranges for each vitamin
Action Threshold: Deficiency: supplement as needed
Symptom Monitoring
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Abdominal pain
- Dyspepsia
- Signs of vitamin deficiency (e.g., fatigue, bone pain, bleeding)
Special Patient Groups
Pregnancy
Use in pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Sevelamer is not absorbed systemically, so fetal exposure is unlikely. However, potential for reduced absorption of fat-soluble vitamins and folic acid should be considered.
Trimester-Specific Risks:
First Trimester:
Low systemic exposure, but potential for nutrient malabsorption.
Second Trimester:
Low systemic exposure, but potential for nutrient malabsorption.
Third Trimester:
Low systemic exposure, but potential for nutrient malabsorption.
Lactation
It is not known whether sevelamer is excreted in human milk. Since sevelamer is not absorbed systemically, it is unlikely to be present in breast milk or to harm a nursing infant. However, potential for reduced absorption of fat-soluble vitamins in the mother should be considered.
Infant Risk:
Low risk
Pediatric Use
Safety and efficacy have not been fully established in pediatric patients. Use in children is off-label and requires careful individualized dosing and monitoring by a specialist. Long-term effects on growth and development are not fully known.
Geriatric Use
No specific dose adjustment is needed for elderly patients. Clinical studies did not identify differences in safety or effectiveness between elderly and younger patients. However, elderly patients may be more susceptible to gastrointestinal side effects like constipation.
Clinical Information
Clinical Pearls
- Sevelamer HCl can cause metabolic acidosis due to chloride exchange; sevelamer carbonate (Renvela) is an alternative that does not have this effect and may be preferred in patients with acidosis.
- Ensure patients understand the importance of taking sevelamer *with* meals, not before or after, for optimal phosphate binding.
- Constipation is a common side effect; advise patients on adequate fluid intake and fiber, and consider stool softeners if needed.
- Monitor for signs of fat-soluble vitamin (A, D, E, K) and folic acid deficiencies, and supplement as necessary, especially in long-term use.
- Patients should be advised to swallow tablets whole and not to chew, crush, or break them, as this can lead to choking or esophageal injury.
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:
Varies widely, typically $100-$500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.