Drugs Details

Drugs Info of Renagel, Renvela
Drugs Details
  • Drugs Type  : FDA
  • Date : 3rd Apr 2015 01:00 am
  • Brand Name : Renagel, Renvela
  • Generic Name : sevelamer (Pronunciation: se VEL a mer)
Descriptions

The active ingredient in Renagel Tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonated. It is known chemically as poly(allylamine-co-N,N'-diallyl 1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1.

Figure 1: Chemical Structure of Sevelamer Hydrochloride

Renagel (sevelamer hydrochloride) Structural Formula Illustration

 

The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin.

Renagel ® Tablets: Each film-coated tablet of Renagel contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. The tablet imprint contains iron oxide black ink.

 

What are the possible side effects of sevelamer (Renagel, Renvela)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sevelamer and call your doctor at once if you have a serious side effect such as:

  • black, bloody, or tarry stools;
  • constipation that gets worse or does not clear up;
  • severe constipation with stomach pain; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;
  • upset...

Read All Potential Side Effects and See Pictures of Renagel »

What are the precautions when taking sevelamer hcl (Renagel)?

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: low blood phosphorus levels, bowel blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (e.g., constipation), stomach/intestinal surgeries, swallowing problems (dysphagia).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits...

Read All Potential Precautions of Renagel »

 

This monograph has been modified to include the generic and brand name in many instances.

 

Indications

RENAGEL® (sevelamer hydrochloride) is indicated for the control of serumphosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied.

Dosage Administration

Patients Not Taking a Phosphate Binder

The recommended starting dose of Renagel is 800 to 1600 mg, which can be administered as one or two 800 mg Renagel® Tablets or two to four 400 mg Renagel® Tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renagel for patients not taking a phosphate binder.

Table 1: Starting Dose for Dialysis Patients Not Taking a Phosphate Binder

SERUM PHOSPHORUS RENAGEL® 800 MG RENAGEL® 400 MG
> 5.5 and < 7.5 mg/dL 1 tablet three times daily with meals 2 tablets three times daily with meals
≥ 7.5 and < 9.0 mg/dL 2 tablets three times daily with meals 3 tablets three times daily with meals
≥ 9.0 mg/dL 2 tablets three times daily with meals 4 tablets three times daily with meals

 

Patients Switching From Calcium Acetate

In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of Renagel and calcium acetate. Table 2 gives recommended starting doses of Renagel based on a patient's current calcium acetate dose.

Table 2: Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renagel

CALCIUM ACETATE 667 MG (TABLETS PER MEAL) RENAGEL® 800 MG (TABLETS PER MEAL) RENAGEL® 400 MG (TABLETS PER MEAL)
1 tablet 1 tablet 2 tablets
2 tablets 2 tablets 3 tablets
3 tablets 3 tablets 5 tablets

 

Dose Titration for All Patients Taking Renagel

Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dL or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary. Table 3 gives a dose titration guideline. The average dose in a Phase 3 trial designed to lower serum phosphorus to 5.0 mg/dL or less was approximately three Renagel 800 mg tablets per meal. The maximum average daily Renagel dose studied was 13 grams.

Table 3: Dose Titration Guideline

SERUM PHOSPHORUS RENAGEL® DOSE
> 5.5 mg/dL Increase 1 tablet per meal at 2 week intervals
3.5 - 5.5 mg/dL Maintain current dose
< 3.5 mg/dL Decrease 1 tablet per meal

 

 
 

How Supplied

Dosage Forms And Strengths

800 mg and 400 mg Tablets.

Storage And Handling

Renagel® 800 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with “RENAGEL 800” containing 800 mg of sevelamer hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel® 800 mg Tablets are packaged in bottles of 180 tablets.

Renagel® 400 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with “RENAGEL 400” containing 400 mg of sevelamer hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel® 400 mg Tablets are packaged in bottles of 360 tablets.

1 Bottle of 30 ct 800 mg Tablets (NDC 58468-0021-3)
1 Bottle of 180 ct 800 mg Tablets (NDC 58468-0021-1)
1 Bottle of 360 ct 400 mg Tablets (NDC 58468-0020-1)

Storage

Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).

Do not use Renagel® after the expiration date on the bottle.

[See USP controlled room temperature]

Protect from moisture.

Distributed by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 USA. Revised: May 2011

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a parallel design study of sevelamer hydrochloride with treatment duration of 52 weeks, adverse reactions reported for sevelamer hydrochloride (n=99) were similar to those reported for the active-control group (n=101). Overall adverse reactions among those treated with sevelamer hydrochloride occurring in > 5% of patients included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%). A total of 27 patients treated with sevelamer and 10 patients treated with comparator withdrew from the study due to adverse reactions.

Based on studies of 8-52 weeks, the most common reason for withdrawal from Renagel was gastrointestinal adverse reactions (3-16%).

In one hundred and forty-three peritoneal dialysis patients studied for 12 weeks most adverse reactions were similar to adverse reactions observed inhemodialysis patients. The most frequently occurring treatment emergent serious adverse reaction was peritonitis (8 reactions in 8 patients [8%] in the sevelamer group and 2 reactions in 2 patients [4%] on active-control). Thirteen patients (14%) in the sevelamer group and 9 patients (20%) in the active-control group discontinued, mostly for gastrointestinal adverse reactions. Patients on peritoneal dialysis should be closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of sevelamer hydrochloride (Renagel®): pruritus, rash, abdominal pain, fecal impaction and uncommon cases of ileus, intestinal obstruction, and intestinal perforation. Appropriate medical management should be given to patients who develop constipation or have worsening of existing constipation to avoid severe complications.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

Read the Renagel (sevelamer hcl) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

Renagel has been studied in human drug-drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol and iron.

Ciprofloxacin

In a study of 15 healthy subjects, a co-administered single dose of 7 Renagel capsules (approximately 2.8 g) decreased the bioavailability of ciprofloxacin by approximately 50%.

Digoxin

In 19 healthy subjects receiving 6 Renagel capsules three times a day with meals for 2 days, Renagel did not alter the pharmacokinetics of a single dose of digoxin.

Warfarin

In 14 healthy subjects receiving 6 Renagel capsules three times a day with meals for 2 days, Renagel did not alter the pharmacokinetics of a single dose of warfarin.

Enalapril

In 28 healthy subjects a single dose of 6 Renagel capsules did not alter the pharmacokinetics of a single dose of enalapril.

Metoprolol

In 31 healthy subjects a single dose of 6 Renagel capsules did not alter the pharmacokinetics of a single dose of metoprolol.

Iron

In 23 healthy subjects, a single dose of 7 Renagel capsules did not alter the absorption of a single oral dose of iron as 200 mg exsiccated ferrous sulfate tablet.

Other Concomitant Drug Therapy

There are no empirical data on avoiding drug interactions between Renagel® and most concomitant drugs. During postmarketing experience, very rare cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride andlevothyroxine. Closer monitoring of TSH levels is therefore recommended in patients receiving both medications.

When administering an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, the drug should be administered at least one hour before or three hours after Renagel, or the physician should consider monitoring blood levels of the drug. Patients taking anti arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials. Special precautions should be taken when prescribing Renagel to patients also taking these medications.

Read the Renagel Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

 
 

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Gastrointestinal Adverse Events

Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders.

Cases of bowel obstruction and perforation have been reported with sevelamer use.

Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery were not included in the Renagel clinical studies.

Monitor Serum Chemistries

Bicarbonate and chloride levels should be monitored.

Monitor for Reduced Vitamins D, E, K (clotting factors) and Folic Acid Levels

In preclinical studies in rats and dogs, sevelamer hydrochloride reduced vitamins D, E, and K (coagulation parameters) and folic acid levels at doses of 6-10 times the recommended human dose. In short-term clinical trials, there was no evidence of reduction in serum levels of vitamins. However, in a one-year clinical trial, 2548 hydroxyvitamin D (normal range 10 to 55 ng/mL) fell from 39 RMG 22 ng/mL to 34 RMG 22 ng/mL (p < 0.01) with sevelamer hydrochloride treatment. Most (approximately 75%) patients in sevelamer hydrochloride clinical trials received vitamin supplements, which is typical of patients on dialysis.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Rats were given sevelamer hydrochloride by diet at 0.3, 1, or 3 g/kg/day. There was an increased incidence of urinary bladder transitional cellpapilloma in male rats of the high dose group (human equivalent dose twice the maximum clinical trial dose of 13 g). Mice received dietary administration of sevelamer hydrochloride at doses of up to 9 g/kg/day (human equivalent dose 3 times the maximum clinical trial dose). There was no increased incidence of tumors observed in mice.

In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a statistically significant increase in the number of structural chromosome aberrations. Sevelamer hydrochloride was not mutagenic in the Ames bacterial mutation assay.

Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study in which the females were treated from 14 days prior to mating through gestation and the males were treated for 28 days prior to mating. The highest dose in this study was 4.5 g/kg/day (human equivalent dose 3 times the maximum clinical trial dose of 13 g).

In pregnant rats given dietary doses of 0.5, 1.5 or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred in mid- and high dose groups (human equivalent doses less than the maximum clinical trial dose of 13 g). In pregnant rabbits given oral doses of 100, 500 or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose).

Use In Specific Populations

Pregnancy

Pregnancy Category C: The effect of Renagel on the absorption of vitamins and other nutrients has not been studied in pregnant women. Requirements for vitamins and other nutrients are increased in pregnancy. In pregnant rats given doses of Renagel during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred. In pregnant rabbits given oral doses of

Renagel by gavage during organogenesis, an increase of early resorptions occurred. [See Nonclinical Toxicology]

Labor and Delivery

No Renagel treatment-related effects on labor and delivery were seen in animal studies. The effects of Renagel on labor and delivery in humans are not known. [See Nonclinical Toxicology]

Pediatric Use

The safety and efficacy of Renagel has not been established in pediatric patients.

Geriatric Use

Clinical studies of Renagel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Renagel has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. Renagel has been given in average doses up to 13 grams per day to hemodialysis patients. There are no reports of overdosage with Renagel in patients. Since Renagel is not absorbed, the risk of systemic toxicity is low.

ContrainDications

Renagel is contraindicated in patients with bowel obstruction.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Patients with chronic kidney disease (CKD) on dialysis retain phosphorusand can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. When the product of serum calcium and phosphorus concentrations (Ca x P) exceeds 55 mg2/dL2, there is an increased risk that ectopic calcification will occur. Hyperphosphatemia plays a role in the development of secondaryhyperparathyroidism in renal insufficiency.

Treatment of hyperphosphatemia includes reduction in dietary intake of phosphate, inhibition of intestinal phosphate absorption with phosphate binders, and removal of phosphate with dialysis. Renagel taken with meals has been shown to decrease serum phosphorus concentrations in patients with CKD who are on dialysis.

Mechanism of Action

Renagel contains sevelamer hydrochloride, a non-absorbed binding crosslinked polymer. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogenbonding. By binding phosphate in the dietary tract and decreasing absorption, sevelamer hydrochloride lowers the phosphate concentration in the serum.

Pharmacodynamics

In addition to effects on serum phosphate levels, sevelamer hydrochloride has been shown to bind bile acids in vitro and in vivo in experimental animal models. Bile acid binding by ion exchange resins is a well-established method of lowering blood cholesterol. Because sevelamer binds bile acids, it may interfere with normal fat absorption and thus may reduce absorption of fat-soluble vitamins such as A, D and K. In clinical trials of sevelamer hydrochloride, both the mean total and LDL cholesterol declined by 15-31%. This effect is observed after 2 weeks. Triglycerides, HDL cholesterol andalbumin did not change.

Pharmacokinetics

A mass balance study using 14C-sevelamer hydrochloride in 16 healthy male and female volunteers showed that sevelamer hydrochloride is not systemically absorbed. No absorption studies have been performed in patients with renal disease.

Clinical Studies

The ability of Renagel to lower serum phosphorus in CKD patients on dialysis was demonstrated in six clinical trials: one double-blind placebo controlled 2-week study (Renagel N=24); two open-label uncontrolled 8-week studies (Renagel N=220) and three active-controlled open-label studies with treatment durations of 8 to 52 weeks (Renagel N=256). Three of the active-controlled studies are described here. One is a crossover study with two 8-week periods comparing Renagel to an active-control. The second is a 52-week parallel study comparing Renagel with active-control. The third is a 12-week parallel study comparing Renagel and active-control in peritoneal dialysis patients.

Active-Control, Cross-Over Study in Hemodialysis Patients

Eighty-four CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus > 6.0 mg/dL) following a two-week phosphate binder washout period received Renagel and active-control for eight weeks each in random order. Treatment periods were separated by a two-week phosphate binder washout period. Patients started on treatment three times per day with meals. Over each eight-week treatment period, at three separate time points the dose of Renagel could be titrated up 1 capsule or tablet per meal (3 per day) to control serum phosphorus, the dose of active-control could also be altered to attain phosphate control. Both treatments significantly decreased mean serum phosphorus by about 2 mg/dL (Table 4).

Table 4: Mean Serum Phosphorus (mg/dL) at Baseline and Endpoint

  RENAGEL®
(N=81)
ACTIVE-CONTROL
(N=83)
Baseline at End of Washout 8.4 8.0
Endpoint 6.4 5.9
Change from Baseline at Endpoint -2.0* -2.1*
(95% Confidence Interval) (-2.5, -1.5) (-2.6, -1.7)
*p < 0.0001, within treatment group comparison

 

The distribution of responses is shown in Figure 2. The distributions are similar for sevelamer hydrochloride and active control. The median response is a reduction of about 2 mg/dL in both groups. About 50% of subjects have reductions between 1 and 3 mg/dL.

Figure 2: Percentage of patients (Y-axis) attaining a phosphorus reduction from baseline (mg/dL) at least as great as the value of the X-axis.

View Enlarged Table

 

Average daily Renagel dose at the end of treatment was 4.9 g (range of 0.0 to 12.6 g).

Active-Control, Parallel Study in Hemodialysis Patients

Two hundred CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus > 5.5 mg/dL) following a two-week phosphate binder washout period were randomized to receive Renagel 800 mg tablets (N=99) or an active-control (N=101). The two treatments produced similar decreases in serum phosphorus. At week 52, using last observation-carried-forward, Renagel and active-control both significantly decreased mean serum phosphorus (Table 5).

Table 5: Mean Serum Phosphorus (mg/dL) and Ion Product at Baseline and Change from Baseline to End of Treatment

  RENAGEL®
(N=94)
ACTIVE-CONTROL
(N=98)
Phosphorus    
Baseline 7.5 7.3
Change from Baseline at Endpoint -2.1 -1.8
Ca x Phosphorus Ion Product    
Baseline 70.5 68.4
Change from Baseline at Endpoint -19.4 -14.2

 

Sixty-one percent of Renagel patients and 73% of the control patients completed the full 52 weeks of treatment.

Figure 3, a plot of the phosphorus change from baseline for the completers, illustrates the durability of response for patients who are able to remain on treatment.

Figure 3: Mean Phosphorus Change from Baseline for Patients who Completed 52 Weeks of Treatment

View Enlarged Table

 

Average daily Renagel dose at the end of treatment was 6.5 g (range of 0.8 to 13 g).

Active-Control, Parallel Study in Peritoneal Dialysis Patients

One hundred and forty-three patients on peritoneal dialysis who were hyperphosphatemic (serum phosphorus > 5.5 mg/dL) following a two-week phosphate binder washout period were randomized to receive Renagel® (N=97) or active-control (N=46) open label for 12 weeks. Average daily Renagel dose at the end of treatment was 5.9 g (range 0.8 to 14.3 g). There were statistically significant changes in serum phosphorus (p < 0.001) for Renagel (-1.6 mg/dL from baseline of 7.5 mg/dL), similar to the active-control.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Dosing Recommendations

The prescriber should inform patients to take Renagel with meals and adhere to their prescribed diets. Instructions should be given on concomitant medications that should be dosed apart from Renagel.

Adverse Reactions

Renagel may cause constipation that if left untreated, may lead to severe complications. Patients should be cautioned to report new onset or worsening of existing constipation promptly to their physician.

This monograph has been modified to include the generic and brand name in many instances.

 

Consumer Overview Uses

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.

 

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, usually 3 times daily with meals or as directed by your doctor. Swallow the tablet whole. Do not crush, chew, or split the tablet. Dosage is based on your medical condition, any other medications you take to lower your phosphate levels, and your response to therapy.

If you are taking the powder form of this medication, check the manufacturer package directions for the proper amount of water to use for your specific dose. Stir the mixture well and drink the mixture within 30 minutes. If the powder settles to the bottom of the glass, then stir again right before drinking.

Use this medication regularly in order to get the most benefit from it. Remember to take it after each meal every day, or on the schedule given to you by your doctor.

Do not take other medications by mouth for 1 hour before you take this medication or for 3 hours afterward. Taking other medications during that time could decrease the effectiveness of the other drugs. Consult your pharmacist for more information.

Consumer Overview Side Effect

SIDE EFFECTS: Headache, diarrhea, stomach upset, nausea, vomiting, cough, gas, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if these unlikely but serious side effects occur: problems with your dialysis access site, severe constipation/inability to have a bowel movement, stomach/abdominal pain or swelling.

Seek immediate medical attention if any of these rare but very serious side effects occur: trouble breathing, chest pain, pain/redness/swelling in the lower legs.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Renagel (sevelamer hcl) Side Effects Center for a complete guide to possible side effects

Learn More »
 

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: low blood phosphorus levels, bowel blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (e.g., constipation), stomach/intestinal surgeries, swallowing problems (dysphagia).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: mycophenolate.

Sevelamer may interfere with the effectiveness of many drugs by making it more difficult for them to be absorbed by the stomach. Consult your pharmacist about the best times to take your medication(s).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. 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.

Laboratory and/or medical tests (such as blood phosphate, calcium, bicarbonate and chloride levels) should be performed regularly to monitor your progress or check for side effects. 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 and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

 

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Renagel, Renvela

Generic Name: sevelamer (Pronunciation: se VEL a mer)

  • What is sevelamer (Renagel)?
  • What are the possible side effects of sevelamer (Renagel)?
  • What is the most important information I should know about sevelamer (Renagel)?
  • What should I discuss with my healthcare provider before taking sevelamer (Renagel)?
  • How should I take sevelamer (Renagel)?
  • What happens if I miss a dose (Renagel)?
  • What happens if I overdose (Renagel)?
  • What should I avoid while taking sevelamer (Renagel)?
  • What other drugs will affect sevelamer (Renagel)?
  • Where can I get more information?

What is sevelamer (Renagel)?

 

Sevelamer is a phosphate binder. Sevelamer helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.

Sevelamer is used to control phosphorus levels in people with chronic kidney disease who are on dialysis.

Sevelamer may also be used for purposes not listed in this medication guide.

Renagel 400 mg

oval, white, imprinted with RENAGEL 400

What are the possible side effects of sevelamer (Renagel)?

 

Get emergency medical help if you have any of thesesigns of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sevelamer and call your doctor at once if you have a serious side effect such as:

  • black, bloody, or tarry stools;
  • constipation that gets worse or does not clear up;
  • severe constipation with stomach pain; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;
  • upset stomach, gas, bloating;
  • diarrhea, mild constipation;
  • tired feeling;
  • itching; or
  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Renagel (sevelamer hcl) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about sevelamer (Renagel)?

 

You should not take this medication if you are allergic to sevelamer, or if you have a bowel obstruction.

Before taking sevelamer, tell your doctor if you have severe constipation, a blockage in your intestines, a stomach or intestinal disorder, trouble swallowing, or if you have recently had stomach or intestinal surgery.

Avoid taking any other medicines within 1 hour before or 3 hours after you take sevelamer. Sevelamer can bind to other medications and make them less effective.

Before taking sevelamer, tell your doctor if you are taking ciprofloxacin (Cipro), a heart rhythm medication, or a seizure medication.

Do not take calcium or other mineral supplements without your doctor's advice. Use only the specific type of calcium or mineral supplement your doctor recommends.

Side Effects Centers
  • Renagel
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Patient Detailed How Take

What should I discuss with my healthcare provider before taking sevelamer (Renagel)?

 

You should not take this medication if you are allergic to sevelamer, or if you have a bowel obstruction.

To make sure you can safely take sevelamer, tell your doctor if you have any of these other conditions:

  • trouble swallowing;
  • severe constipation;
  • a blockage in your intestines;
  • a stomach or intestinal disorder; or
  • if you have recently had stomach or intestinal surgery.

FDA pregnancy category C. It is not known whether sevelamer will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether sevelamer passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sevelamer (Renagel)?

 

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take sevelamer with meals.

Do not crush, chew, or break the sevelamer tablet. Swallow the pill whole. Sevelamer tablets expand when they are wet, and breaking or crushing the pill may make it harder to swallow.

Sevelamer powder must be dissolved in water before you take it. The 0.8-gram packet should be mixed with at least 1 ounce (2 tablespoons) of water. The 2.4-gram packet should be mixed with at least 2 ounces (4 tablespoons) of water.

Stir the powder in water until it is completely dissolved. Drink all of this mixture right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Sevelamer may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Renagel
  • Renvela

Patient Detailed Avoid Taking

What happens if I miss a dose (Renagel)?

 

Take the missed dose as soon as you remember. Be sure to take the missed dose with food. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Renagel)?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sevelamer (Renagel)?

 

Avoid taking any other medicines within 1 hour before or 3 hours after you take sevelamer. Sevelamer can bind to other medications and make them less effective.

Do not take calcium or other mineral supplements without your doctor's advice. Use only the specific type of calcium or mineral supplement your doctor recommends.

What other drugs will affect sevelamer (Renagel)?

 

Tell your doctor about all other medicines you use, especially:

  • ciprofloxacin (Cipro);
  • levothyroxine (Synthroid, Levothroid, Levoxyl);
  • a heart rhythm medication; or
  • a seizure medication.

This list is not complete and other drugs may interact with sevelamer. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about sevelamer.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 9.02. Revision date: 7/27/2012.

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Side Effects Centers
  • Renagel
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