Dosing & Uses
Dosage Forms & Strengths
tablet
- 400mg (Renagel)
- 800mg (Renagel, Renvela)
powder packet for oral suspension
- 800mg (Renvela)
- 2400mg (Renvela)
Serum Phosphorus Regulation
Indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) who are on dialysis
Initial dose
Not taking phosphate binder
- Serum PO4 >9 mg/dL [2.91 mmol/L]: 1600 mg PO q8hr with meals
- Serum PO4 7.5-9 mg/dL [2.42-2.91 mmol/L]: 1200-1600 mg PO q8hr with meals
- Serum PO4 5.5-7.5 mg/dL [1.78-2.42 mmol/L]: 800 mg PO q8hr with meals
Switching from calcium acetate
- Substitute 800 mg Renagel or Renvela for 667 mg of Ca-acetate
- Substitute 1600 Renvela or Renagel for 1334 mg of Ca-acetate
- Substitute 2400 mg Renvela or Renagel for 2001 mg Ca-acetate
Maintenance dose
- Target goal is serum phosphorus ≤5.5 mg/dL
- Serum PO4 >5.5 mg/dL [>1.78 mmol/L]: Increase dose by 400-800 mg per meal
- Serum PO4 3.5-5.5 mg/dL [1.13-1.78 mmol/L]: Maintain current dose
- Serum PO4 <3.5 mg/dL [1.13 mmol/L] decrease by 400-800 mg per meal
Dose titration
- Titrate dose; increase by 400-800 mg per meal at 2-week intervals as necessary to achieve target serum phosphorus levels
- Based on clinical studies, the average prescribed adult daily dose is ~7.2 g/day
- Highest daily adult dose studied was 14 grams in CKD patients on dialysis
Dosing Considerations
Renagel = Renvela on a per gram basis
Dosage Forms & Strengths
tablet
- 800mg (Renvela)
powder packet for oral suspension
- 800mg (Renvela)
- 2400mg (Renvela)
Serum Phosphorus Regulation
Indicated for the control of serum phosphorus in with chronic kidney disease (CKD) who are on dialysis in children aged ≥6 yr
<6 years: Safety and efficacy not established
See Administration for oral suspension preparation instructions
Initial dose (not taking phosphate binder)
- BSA ≥0.75 to <1.2 m²: 800 mg per meal/snack; titrate up or down by 400 mg-increments
- BSA ≥1.2 m²: 1600 mg per meal/snack; titrate up or down by 800 mg-increments
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- potassium phosphates, IV
sevelamer decreases effects of potassium phosphates, IV by cation binding in GI tract. Contraindicated. Sevelamer decreases serum phosphate concentration by binding dietary phosphate.
- sodium phosphates, IV
sevelamer decreases effects of sodium phosphates, IV by cation binding in GI tract. Contraindicated. Sevelamer decreases serum phosphate concentration by binding dietary phosphate.
Serious - Use Alternative (1)
- erdafitinib
sevelamer, erdafitinib. Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid coadministration during initial dosing adjustment period (ie, first 21 days). Increases in serum phosphate levels are a pharmacodynamic effect of FGFR inhibition. Serum phosphate binders may obscure decisions regarding initial dosage increase.
Monitor Closely (45)
- acebutolol
sevelamer decreases levels of acebutolol by increasing elimination. Use Caution/Monitor.
- acetazolamide
sevelamer decreases levels of acetazolamide by increasing elimination. Use Caution/Monitor.
- adenosine
sevelamer decreases levels of adenosine by increasing elimination. Use Caution/Monitor.
- amiodarone
sevelamer decreases levels of amiodarone by increasing elimination. Use Caution/Monitor.
- carbamazepine
sevelamer decreases levels of carbamazepine by increasing elimination. Use Caution/Monitor.
- ciprofloxacin
sevelamer decreases levels of ciprofloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Administer oral quinolones at least 1 hour before or 3 hours after sevelamer. .
- clonazepam
sevelamer decreases levels of clonazepam by increasing elimination. Use Caution/Monitor.
- diazepam
sevelamer decreases levels of diazepam by increasing elimination. Use Caution/Monitor.
- dichlorphenamide
dichlorphenamide, sevelamer. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.
- digoxin
sevelamer decreases levels of digoxin by increasing elimination. Use Caution/Monitor.
- disopyramide
sevelamer decreases levels of disopyramide by increasing elimination. Use Caution/Monitor.
- encainide
sevelamer decreases levels of encainide by increasing elimination. Use Caution/Monitor.
- eslicarbazepine acetate
sevelamer decreases levels of eslicarbazepine acetate by increasing elimination. Modify Therapy/Monitor Closely.
- esmolol
sevelamer decreases levels of esmolol by increasing elimination. Use Caution/Monitor.
- ethosuximide
sevelamer decreases levels of ethosuximide by increasing elimination. Use Caution/Monitor.
- felbamate
sevelamer decreases levels of felbamate by increasing elimination. Use Caution/Monitor.
- flecainide
sevelamer decreases levels of flecainide by increasing elimination. Use Caution/Monitor.
- fosphenytoin
sevelamer decreases levels of fosphenytoin by increasing elimination. Use Caution/Monitor.
- gabapentin
sevelamer decreases levels of gabapentin by increasing elimination. Use Caution/Monitor.
- gabapentin enacarbil
sevelamer decreases levels of gabapentin enacarbil by increasing elimination. Use Caution/Monitor.
- ibutilide
sevelamer decreases levels of ibutilide by increasing elimination. Use Caution/Monitor.
- lacosamide
sevelamer decreases levels of lacosamide by increasing elimination. Use Caution/Monitor.
- lamotrigine
sevelamer decreases levels of lamotrigine by increasing elimination. Use Caution/Monitor.
- levetiracetam
sevelamer decreases levels of levetiracetam by increasing elimination. Use Caution/Monitor.
- lidocaine
sevelamer decreases levels of lidocaine by increasing elimination. Use Caution/Monitor.
- lorazepam
sevelamer decreases levels of lorazepam by increasing elimination. Use Caution/Monitor.
- methsuximide
sevelamer decreases levels of methsuximide by increasing elimination. Use Caution/Monitor.
- mexiletine
sevelamer decreases levels of mexiletine by increasing elimination. Use Caution/Monitor.
- oxcarbazepine
sevelamer decreases levels of oxcarbazepine by increasing elimination. Use Caution/Monitor.
- phenobarbital
sevelamer decreases levels of phenobarbital by increasing elimination. Use Caution/Monitor.
- phenytoin
sevelamer decreases levels of phenytoin by increasing elimination. Use Caution/Monitor.
- primidone
sevelamer decreases levels of primidone by increasing elimination. Use Caution/Monitor.
- procainamide
sevelamer decreases levels of procainamide by increasing elimination. Use Caution/Monitor.
- propafenone
sevelamer decreases levels of propafenone by increasing elimination. Use Caution/Monitor.
- propranolol
sevelamer decreases levels of propranolol by increasing elimination. Use Caution/Monitor.
- quinidine
sevelamer decreases levels of quinidine by increasing elimination. Use Caution/Monitor.
- rufinamide
sevelamer decreases levels of rufinamide by increasing elimination. Use Caution/Monitor.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of sevelamer by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of sevelamer by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sotalol
sevelamer decreases levels of sotalol by increasing elimination. Use Caution/Monitor.
- tiagabine
sevelamer decreases levels of tiagabine by increasing elimination. Use Caution/Monitor.
- topiramate
sevelamer decreases levels of topiramate by increasing elimination. Use Caution/Monitor.
- valproic acid
sevelamer decreases levels of valproic acid by increasing elimination. Use Caution/Monitor.
- verapamil
sevelamer decreases levels of verapamil by increasing elimination. Use Caution/Monitor.
- zonisamide
sevelamer decreases levels of zonisamide by increasing elimination. Use Caution/Monitor.
Minor (0)
Adverse Effects
>10%
Vomiting (22%)
Nausea (20%)
Diarrhea (19%)
Dyspepsia (16%)
Nasopharyngitis (14%)
Limb pain (13%)
Pruritus (13%)
Arthralgia (12%)
Bronchitis (11%)
Dyspnea (10%)
Hypertension (10%)
1-10%
Abdominal pain (9%)
Constipation (8%)
Flatulence (8%)
Peritonitis (during peritoneal dialysis: 8%)
Hypercalcemia (5-7%)
Frequency Not Defined
Back pain
Cough
Headache
Pyrexia
Upper respiratory infection
Pruritus
Rash
Intestinal perforation
Fecal impaction
Intestinal obstruction
Postmarketing Reports
Hypersensitivity
Bleeding gastrointestinal ulcers, colitis, ulceration, necrosis
Warnings
Contraindications
Hypersensitivity
Bowel obstruction
Cautions
Caution in dysphagia, GI motility disorders, GI surgery
Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation reported; inflammatory disorders may resolve upon discontinuation; reevaluate treatment in patients who develop severe gastrointestinal symptoms
Tablets should not be crushed, broken, or chewed (tablets rapidly expand and become a choking hazard)
Dysphagia and esophageal tablet retention reported, in some cases requiring hospitalization and intervention; consider sevelamer oral suspension in patients with history of swallowing disorders
May decrease GI absorption of antiarrhythmic, fat soluble vitamins, folic acid, and antiseizure medications; take medications 1 hour before or 3 hours after sevelamer dose
Monitor serum bicarbonate and chloride levels
Monitor fat soluble vitamin and folic acid levels, especially in pregnancy
Safety/efficacy with dialysis not studied
Pregnancy & Lactation
Pregnancy
Not absorbed systemically following oral administration and maternal use not expected to result in fetal exposure to the drug
May decrease serum levels of fat soluble vitamins and folic acid in pregnant women; consider supplementation
Lactation
Not absorbed systemically by mother following oral administration; breastfeeding is not expected to result in exposure of child to drug
May decrease serum levels of fat soluble vitamins and folic acid in pregnant women; consider supplementation
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Polymeric phosphate binder; decreases serum phosphate concentrations without changing calcium, aluminum, or bicarbonate concentrations
Absorption
No intestinal absorption
Elimination
Excretion: Feces
Administration
Oral Suspension Preparation
Minimum amount of water for suspension
- 400 mg (ie, one-half 800 mg packet): 30 mL
- 800 mg: 30 mL
- 2400 mg: 60 mL
Instruct patients to stir the mixture vigorously (it does not dissolve), resuspend, if necessary, right before administration, and drink the entire preparation within 30 minutes
As an alternative to water, the entire contents of the sachet may be premixed with a small amount of food or beverage and consumed immediately (within 30 minutes) as part of the meal
Do not heat powder for oral suspension (eg, microwave) or add to heated foods or liquids
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| sevelamer HCl oral - | 400 mg tablet |  | |
| sevelamer HCl oral - | 800 mg tablet |  | |
| sevelamer HCl oral - | 800 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
sevelamer HCl oral
SEVELAMER - ORAL
(seh-VELL-uh-mer)
COMMON BRAND NAME(S): Renagel, Renvela
USES: Sevelamer is used to lower high blood phosphorus (phosphate) levels in patients who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Sevelamer works by holding onto phosphate from the diet so that it can pass out of your body.
HOW TO USE: Take this medication by mouth as directed by your doctor, usually 3 times daily with meals. Swallow the tablet whole. Do not crush, chew, or split the tablet. The dosage is based on your medical condition, any other medications you take to lower your phosphate levels, and your response to treatment. In children, the dosage is also based on body size.If you are taking the powder form of this medication, check the manufacturer package directions for mixing with water, beverage, or food and taking it within 30 minutes. Follow the directions for the proper amount of water to use for your dose. Stir the mixture well and drink all of it. If the powder settles to the bottom of the cup, stir again right before drinking. You may also mix the powder with a small amount of food or beverage to take as part of a meal. If mixing with food or beverage, do not heat the powder or add to heated foods or liquids.Take this medication regularly in order to get the most benefit from it. Remember to take it 3 times a day with meals, or on the schedule given to you by your doctor.
SIDE EFFECTS: Headache, diarrhea, stomach upset, nausea, vomiting, cough, gas, or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: problems with your dialysis access site, severe constipation/inability to have a bowel movement, signs of stomach/intestinal bleeding or ulcers (such as black/bloody stools, vomit that looks like coffee grounds, stomach/abdominal pain, dizziness).Get medical help right away if you have any very serious side effects, including: trouble breathing, chest pain, pain/redness/swelling in the lower legs.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking sevelamer, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood phosphorus levels, stomach/intestinal problems (such as blockage, colitis, constipation, ulcers), stomach/intestinal surgeries, swallowing problems (dysphagia).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Sevelamer may interfere with the effectiveness of some drugs (including ciprofloxacin, mycophenolate, thyroid medications such as levothyroxine, among others) by making it more difficult for them to be absorbed by the stomach. Ask your pharmacist about the best times to take your other medications.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Your doctor may direct you to follow a special diet to help lower your blood phosphate levels. Follow the diet closely.Do not share this medication with others.Lab and/or medical tests (such as blood phosphate, calcium, bicarbonate and chloride levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, skip the missed dose unless you have just eaten. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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