Renagel 800mg Tablets
It is used to lower high phosphate levels.
Drug Class
Phosphate Binder
Pharmacologic Class
Non-calcium, Non-aluminum Phosphate Binder
Pregnancy Category
Category C
FDA Approved
Oct 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Renagel is a medication used by people with kidney disease who are on dialysis. It works by binding to phosphate from the food you eat, preventing your body from absorbing too much of it. This helps keep your phosphate levels in a healthy range, which is important for your bones and overall health.
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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are 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 Renagel with meals or snacks, as directed by your doctor. Do not crush, chew, or break the tablets; swallow them whole.
- Follow your prescribed diet, especially regarding phosphate intake, as this medication works best when combined with dietary restrictions.
- If you miss a dose, take it with your next meal. Do not take a double dose.
- Take other medications at least 1 hour before or 3 hours after Renagel to prevent interactions, unless otherwise advised by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 800 mg (one tablet) three times daily with meals. Titrate based on serum phosphate levels.
Dose Range:
800 - 4800 mg
Condition-Specific Dosing:
hyperphosphatemia_ckd_dialysis:
Initial dose: 800 mg three times daily with meals for patients with serum phosphate > 6.0 mg/dL. For serum phosphate 5.5-6.0 mg/dL, initial dose 800 mg three times daily. For serum phosphate < 5.5 mg/dL, initial dose 800 mg three times daily. Adjust dose by 800 mg increments every 2-4 weeks to achieve target serum phosphate levels. Max dose: 4800 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients under 6 years of age or those with pre-dialysis CKD. Limited data for adolescents on dialysis, generally similar dosing to adults based on body surface area or weight, but not routinely recommended without specific guidance.)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (indicated for CKD on dialysis)
Moderate:
No adjustment needed (indicated for CKD on dialysis)
Severe:
No adjustment needed (indicated for CKD on dialysis)
Dialysis:
Standard dosing as described for adults with hyperphosphatemia on dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended (Sevelamer is not systemically absorbed)
Pharmacology
Mechanism of Action
Sevelamer hydrochloride is a non-absorbed phosphate binder. 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 negatively charged 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:
Should 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:
Not applicable (not absorbed, excreted unchanged)
Pharmacodynamics
OnsetOfAction:
Within days (phosphate binding begins immediately, but serum phosphate reduction takes time)
PeakEffect:
Weeks (after dose titration)
DurationOfAction:
Dependent on continued administration with meals
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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 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. 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 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, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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 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. 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 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, consult 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 or new onset of constipation
- Severe abdominal pain
- Difficulty swallowing
- Choking sensation
- Unusual or severe nausea or vomiting
- Signs of bowel obstruction (e.g., severe bloating, inability to pass gas or stool)
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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you have
To ensure your safety, always check with your doctor before:
Starting any new medication
Stopping any medication
Changing the dose of any medication
This will help your doctor determine whether it is safe for you to take this medication with your other medications 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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you have
To ensure your safety, always check with your doctor before:
Starting any new medication
Stopping any medication
Changing the dose of any medication
This will help your doctor determine whether it is safe for you to take this medication with your other medications 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. 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 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.
Before taking this medication, it is vital to notify your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of this medication to both you and your baby, ensuring you make an informed decision about your treatment.
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 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.
Before taking this medication, it is vital to notify your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of this medication to both you and your baby, ensuring you make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Severe constipation
- Abdominal discomfort
- Nausea
- Vomiting
What to Do:
There are no specific antidotes. Management is supportive. Contact a poison control center or seek immediate medical attention. Call 1-800-222-1222.
Drug Interactions
Major Interactions
- Ciprofloxacin (reduced absorption of ciprofloxacin when co-administered with sevelamer)
- Mycophenolate mofetil (reduced absorption of mycophenolate mofetil when co-administered with sevelamer)
Moderate Interactions
- Levothyroxine (reduced absorption of levothyroxine; administer at least 4 hours before sevelamer)
- Warfarin (potential for reduced absorption; monitor INR closely)
- Antiarrhythmic agents (e.g., amiodarone, quinidine - potential for reduced absorption; administer at different times)
- Anticonvulsants (e.g., phenytoin - potential for reduced absorption; administer at different times)
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 Bicarbonate
Rationale: To assess acid-base status, as sevelamer hydrochloride may contribute to acidosis.
Timing: Prior to initiation of therapy.
Intact Parathyroid Hormone (iPTH)
Rationale: To assess for secondary hyperparathyroidism, which is often linked to hyperphosphatemia.
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 target for CKD Stage 5D)
Action Threshold: Adjust dose if outside target range.
Serum Calcium
Frequency: Monthly or as clinically indicated.
Target: 8.4-10.2 mg/dL (corrected for albumin)
Action Threshold: Investigate and manage if persistently low or high.
Serum Bicarbonate
Frequency: Periodically, especially if using sevelamer hydrochloride.
Target: 22-29 mEq/L
Action Threshold: Monitor for metabolic acidosis; consider switching to sevelamer carbonate if acidosis is a concern.
iPTH
Frequency: Every 3-6 months or as clinically indicated.
Target: 150-300 pg/mL (KDOQI target for CKD Stage 5D)
Action Threshold: Adjust phosphate binder and/or vitamin D analog therapy if outside target range.
Symptom Monitoring
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Abdominal pain
- Dyspepsia
- Pruritus (may indicate uncontrolled phosphate)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses, but human data are limited. Sevelamer is not systemically absorbed.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show some risk at high doses.
Second Trimester:
Limited human data; animal studies show some risk at high doses.
Third Trimester:
Limited human data; animal studies show some risk at high doses.
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. Consider the benefits of breastfeeding and the mother's clinical need for sevelamer.
Infant Risk:
Low (due to lack of systemic absorption)
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 6 years of age or in pediatric patients with pre-dialysis CKD. Limited data exist for adolescents on dialysis, where dosing may be based on body surface area or weight, but generally not a first-line agent without specific guidance.
Geriatric Use
No specific dose adjustment is required for elderly patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, given the lack of systemic absorption, age-related pharmacokinetic changes are not expected to impact efficacy or safety significantly.
Clinical Information
Clinical Pearls
- Renagel (sevelamer hydrochloride) may contribute to metabolic acidosis due to its chloride content. Renvela (sevelamer carbonate) is an alternative that may be preferred in patients prone to acidosis.
- Patients should be instructed to swallow tablets whole and not to crush, chew, or break them, as this can lead to choking or difficulty swallowing.
- Ensure patients understand the importance of taking sevelamer with meals to maximize its phosphate-binding efficacy.
- Monitor for gastrointestinal side effects, especially constipation, and manage appropriately (e.g., fiber, stool softeners). Severe constipation can lead to serious complications like bowel obstruction.
- Advise patients to separate administration of sevelamer from other oral medications, especially those with narrow therapeutic indices, to prevent reduced absorption.
Alternative Therapies
- Sevelamer carbonate (Renvela)
- Calcium acetate (PhosLo)
- Calcium carbonate
- Lanthanum carbonate (Fosrenol)
- Ferric citrate (Auryxia)
- Sucroferric oxyhydroxide (Velphoro)
Cost & Coverage
Average Cost:
Not available (varies widely by pharmacy and plan) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often preferred generic or non-preferred brand)
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 occurred.