Renvela

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Renvela uses


1. INDICATIONS AND USAGE

Renvela® Renvela is a Registered Trademark of Genzyme Corporation. (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renvela in CKD patients who are not on dialysis have not been studied.

2. DOSAGE AND ADMINISTRATION


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

Serum Phosphorus Renvela® 800 mg Renvela® 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 Renvela and calcium acetate. Table 2 gives recommended starting doses of Renvela based on a patient's current calcium acetate dose.

Calcium Acetate 667 mg

(Tablets per meal)

Renvela® 800 mg

(Tablets per meal)

Renvela® 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 Renvela. 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 Renvela 800 mg tablets per meal. The maximum average daily Renvela dose studied was 13 grams.

Serum Phosphorus Renvela® 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

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3. DOSAGE FORMS AND STRENGTHS

800 mg and 400 mg Tablets.

4. CONTRAINDICATIONS

Renvela is contraindicated in patients with bowel obstruction.

Renvela is contraindicated in patients with known hypersensitivity to Renvela hydrochloride or to any of the excipients.

5. WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Adverse Events

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

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

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

5.2 Monitor Serum Chemistries

Bicarbonate and chloride levels should be monitored.

5.3 Monitor for Reduced Vitamins D, E, K and Folic Acid Levels

In preclinical studies in rats and dogs, Renvela 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, 25-hydroxyvitamin D (normal range 10 to 55 ng/mL) fell from 39 ± 22 ng/mL to 34 ± 22 ng/mL (p<0.01) with Renvela hydrochloride treatment. Most (approximately 75%) patients in Renvela hydrochloride clinical trials received vitamin supplements, which is typical of patients on dialysis.

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6. ADVERSE REACTIONS


To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-847-0069 and or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 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 Renvela hydrochloride with treatment duration of 52 weeks, adverse reactions reported for Renvela hydrochloride (n=99) were similar to those reported for the active-control group (n=101). Overall adverse reactions among those treated with Renvela 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 Renvela 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 Renvela 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 in hemodialysis patients. The most frequently occurring treatment emergent serious adverse reaction was peritonitis (8 reactions in 8 patients [8%] in the Renvela group and 2 reactions in 2 patients [4%] on active-control). Thirteen patients (14%) in the Renvela 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.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Renvela hydrochloride (Renagel®): hypersensitivity, 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.

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7. DRUG INTERACTIONS

There are no empirical data on avoiding drug interactions between Renvela® and most concomitant oral drugs. For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs . The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product. Where possible consider monitoring clinical responses and/or blood levels of concomitant drugs that have a narrow therapeutic range.

Oral drugs for which Renvela did not alter the pharmacokinetics when administered concomitantly

Digoxin

Enalapril

Iron

Metoprolol

Warfarin


Oral drugs that have demonstrated interaction with Renvela and are to be dosed separately from Renvela


Dosing Recommendations


Ciprofloxacin


Take at least 2 hours before or 6 hours after Renvela


Mycophenolate mofetil


Take at least 2 hours before Renvela


During postmarketing experience, cases of increased phosphate levels have been reported in patients taking proton pump inhibitors co-administered with Renvela hydrochloride.

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8. USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C: The effect of Renvela 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 Renvela 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 Renvela by gavage during organogenesis, an increase of early resorptions occurred.

8.2 Labor and Delivery

No Renvela treatment-related effects on labor and delivery were seen in animal studies. The effects of Renvela on labor and delivery in humans are not known.

8.4 Pediatric Use

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

8.5 Geriatric Use

Clinical studies of Renvela 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.

10. OVERDOSAGE

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

11. DESCRIPTION

The active ingredient in Renvela Tablets is Renvela hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Renvela hydrochloride is poly 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. Renvela hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1.

Figure 1. Chemical Structure of Renvela Hydrochloride


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

Figure 2

14.2 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 Renvela 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, Renvela and active-control both significantly decreased mean serum phosphorus (Table 6).

Renvela®

(N=94)

Active-Control

(N=98)


Phosphorus


Baseline


7.5


7.3


Change from Baseline at Endpoint


-2.1


-1.8


Ca × Phosphorus Ion Product


Baseline


70.5


68.4


Change from Baseline at Endpoint


-19.4


-14.2


Sixty-one percent of Renvela 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

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

Figure 3

14.3 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 Renvela® (N=97) or active-control (N=46) open label for 12 weeks. Average daily Renvela 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 Renvela (-1.6 mg/dL from baseline of 7.5 mg/dL), similar to the active-control.

16. HOW SUPPLIED/STORAGE AND HANDLING

Renagel® 800 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with "RENAGEL 800" containing 800 mg of Renvela hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel® 800 mg Tablets are overbagged with 10 tablets per bag, NDC 55154-9727-0.

Renagel® 400 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with "RENAGEL 400" containing 400 mg of Renvela hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel® 400 mg Tablets are overbagged with 10 tablets per bag, NDC 55154-9726-0.

Repackaged By:

Cardinal Health

Zanesville, OH 43701

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

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

Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Dosing Recommendations

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

Adverse Reactions

Renvela 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.

Distributed by:

Genzyme Corporation

500 Kendall Street

Cambridge, MA 02142 USA

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L3735909UK1109

L37361390606

Renagel®

(sevelamer hydrochloride) Tablets

400 mg

pouch

RENAGEL® 400 MG

Renvela Hydrochloride Tablets

10 TABLETS

Renagel®

(sevelamer hydrochloride) tablet

800 mg

pouch

Renagel® 800 mg

Renvela Hydrochloride Tablets

10 Tablets

Renvela pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Renvela available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Renvela destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Renvela Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Renvela pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Sevelamer". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "Sevelamer". http://www.drugbank.ca/drugs/DB0065... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Renvela?

Depending on the reaction of the Renvela after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Renvela not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Renvela addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Renvela, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Renvela consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Three visitors reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Renvela is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Expensive3
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Renvela drug as prescribed by the doctor?

Few medications can be taken 3 times in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Renvela is mentioned below.
Visitors%
3 times in a day1
100.0%

One visitor reported doses

What is the dose of Renvela drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 501mg-1g. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
501mg-1g1
100.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Two visitors reported age

Visitors%
30-451
50.0%
> 601
50.0%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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