Precautions
Since sevelamer is not absorbed, the risk of systemic toxicity is low. The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ® ).
Is Renvela a systemic drug?
Renvela Description. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate-binding, is the same.
What is Renvela sevelamer carbonate?
Renvela Description. Renvela® Powder: Each packet of Renvela Powder contains 0.8 g or 2.4 g of sevelamer carbonate on an anhydrous basis. The inactive ingredients are natural and artificial citrus flavor, propylene glycol alginate, sodium chloride, sucralose, and ferric oxide (yellow).
What are the ingredients in Renvela?
Renvela is contraindicated in patients with bowel obstruction. Renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
What are the contraindications for Renvela?
What is Renvela?
What other drugs will affect Renvela?
How long after taking Renvela can you take Sevelamer?
How old do you have to be to use Renvela?
Is Renvela safe for babies?
What to tell your doctor before taking Renvela?
Can Renvela harm a baby?
See 4 more
About this website
Does Renvela contain calcium?
Renvela does not contain any calcium. Serum calcium levels should therefore be monitored at regular intervals and elemental calcium should be given as a supplement if required. Metabolic acidosis Patients with chronic kidney disease are predisposed to developing metabolic acidosis.
Is sevelamer calcium-based?
Objective: Current phosphate binders used in hemodialysis patients include calcium-based binders that result in frequent hypercalcemia. The use of a calcium- and aluminum-free phosphate-binding polymer in hemodialysis (sevelamer) disclosed efficacy in the short and long-term studies.
What is Renvela made of?
Renvela® Tablets: Each film-coated tablet of Renvela contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglycerides, microcrystalline cellulose, sodium chloride and zinc stearate. The tablet imprint contains iron oxide black ink.
Does sevelamer affect calcium?
Sevelamer reduces calcium load and maintains a low calcium-phosphorus ion product in dialysis patients. J Nephrol.
What are calcium free phosphate binders?
At present, there are three types of non-calcium-based phosphate binders available: sevelamer, lanthanum carbonate, and magnesium salts. These non-calcium-based phosphate binders can each reduce serum phosphorus levels depending on an adequate prescribed dose and on the adherence of the patient to treatment.
Do phosphate binders increase calcium?
They would not induce an increase in calcium levels but may have relevant side effects, including gastrointestinal symptoms for sevelamer and risk of tissue accumulation for lanthanum. Accordingly, new phosphate binders are under investigation and some of them have already been approved.
Is sevelamer the same as calcium acetate?
The most commonly used phosphate binding agents are sevelamer (carbonate and hydrochloride) and calcium acetate; sevelamer is available only as a trade name product and is much costlier than calcium acetate.
Why do dialysis patients take Renvela?
Renvela® (sevelamer carbonate) is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Renagel® (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
Does PhosLo increase calcium?
Calcium acetate (PhosLo) can raise your blood calcium levels (hypercalcemia), which can lead to heart rhythm problems and seizures, especially if you are taking calcium supplements or eating calcium-containing foods. Signs and symptoms can include losing your appetite, nausea, vomiting, or constipation.
Does sevelamer cause hypocalcemia?
In three randomized trials (4–6) and other studies (6,30), sevelamer was found to be equivalent to calcium-based binders with respect to phosphorus-lowering ability without causing clinical hypocalcemia.
Is calcium carbonate a phosphate binder?
Calcium carbonate is the most common form of phosphate binder prescribed, particularly in non-dialysis chronic kidney disease. It is typically given to patients with advanced chronic kidney disease, including those receiving dialysis.
Can you take sevelamer and calcium acetate combination?
The combination of sevelamer hydrochloride and CaCO3 is a suitable regimen for hyperphosphatemia treatment in HD patients because it avoids both the hypercalcemia of CaCO3 and the adverse effects of sevelamer hydrochloride when each is used as single-drug therapy.
What is sevelamer used for?
Sevelamer is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with chronic kidney disease who are on dialysis. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: Powder for Suspension.
When should I take sevelamer?
Sevelamer comes as a tablet and as a powder for suspension to take by mouth. It is usually taken three times a day with meals.
Before Taking This Medicine
You should not take Renvela if you are allergic to sevelamer, or if you have a bowel obstruction.To make sure Renvela is safe for you, tell your do...
How Should I Take Renvela?
Take Renvela exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose...
Renvela Dosing Information
Usual Adult Dose for Hyperphosphatemia of Renal Failure:Initial Dosing for patients not on a phosphate binder: 800 mg to 1600 mg orally 3 times a d...
What Happens If I Miss A Dose?
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 sc...
What Should I Avoid While Taking Renvela?
You may be taking other medicines that should not be taken at the same time. Taking Renvela can make it harder for your body to absorb certain drug...
What Other Drugs Will Affect Renvela?
Other drugs may interact with Renvela, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your heal...
Renvela 800mg Tablet: View Uses, Side Effects, Price and Substitutes | 1mg
Renvela 800mg Tablet is used in the treatment of High phosphate levels in blood. View Renvela 800mg Tablet (bottle of 30 tablets) uses, composition, side-effects, price, substitutes, drug interactions, precautions, warnings, expert advice and buy online at best price on 1mg.com
Renvela Dosage Guide - Drugs.com
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 4 Oct 2022), Cerner Multum™ (updated 21 Sep 2022), ASHP (updated 12 Sep 2022 ...
Renvela Interactions with Other Medication - WebMD
Does Renvela Interact with other Medications? Severe Interactions . These medications are not usually taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in ...
What is the active ingredient in Renvela?
The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ® ). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate-binding, is the same.
What is Renvela carbonate?
Renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
How long is the sevelamer carbonate washout period?
This study included a washout period for patients on a phosphate binder, a 2-week, double-blind, fixed-dose period (FDP) in which patients were randomized to sevelamer carbonate (n=50) or placebo (n=51), and a 26-week, open-label, sevelamer carbonate dose titration period (DTP). Most patients were 13 to 18 years of age (73%) and had a BSA ≥1.2 m 2 (84%). Approximately 78% of patients were CKD patients on dialysis.
How much sevelamer hydrochloride is needed for ciprofloxacin?
Coadministered single dose of 2.8 grams of sevelamer hydrochloride in fasted state decreased the bioavailability of ciprofloxacin by approximately 50% in healthy subjects.
How does sevelamer carbonate interact with phosphate?
These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum ( serum phosphorus).
What is the median response of sevelamer hydrochloride?
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.
How much sevelamer is needed for dialysis?
In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.
What is Renvela?
Renvela has active ingredients of sevelamer carbonate. eHealthMe is studying from 10,236 Renvela users for its effectiveness, alternative drugs and more.
What is phase IV of Renvela?
The phase IV clinical study analyzes what interactions people who take Renvela and Calcium acetate have. It is created by eHealthMe based on reports of 53 people who take Renvela and Calcium acetate from the FDA, and is updated regularly.
Is sevelamer a CBB?
The non–CBBs sevelamer hydrochloride, sevelamer carbonate, and lanthanum carbonate are also approved in many countries to manage hyperphosphatemia. A Cochrane systematic review and meta-analysis to March of 2010 regarded data as insufficient to establish superiority of non-CBB agents over CBBs for mortality ( 8 ). However, using data to 2012, Jamal et al. ( 9) reported significantly lower all–cause mortality with non-CBBs than CBBs and called for research to compare mortality among non-CBBs ( 9 ).
Does sevelamer lower serum Ca?
Sevelamer was also associated with lower serum Ca, higher iPTH, lower total and LDL-C, a reduced risk of hypercalcemia versus CBBs, and a marginally increased risk of combined gastrointestinal adverse events. In contrast to the earlier Cochrane review ( 8 ), sevelamer and CBBs did not differ significantly for end of study serum phosphate. Serum bicarbonate values were lower with sevelamer (hydrochloride and carbonate coanalyzed), likely reflecting the lower buffering capacity of sevelamer hydrochloride than Ca carbonate ( 46, 47 ).
Does sevelamer reduce mortality?
In this meta-analysis, the RR for mortality was significantly reduced for sevelamer recipients who were new to dialysis, patients with vascular calcification at baseline, and those with baseline iPTH ≥300 pg/ml. Although these results are in accord with current KDIGO cautions on Ca use in patients with CKD-MBD, such subgroup analyses should be interpreted circumspectly. Study characteristics also influenced outcomes, with mortality lower for patients treated with sevelamer in studies of ≥100 participants, ≥1-year duration, ≤20% loss to follow-up, and a low risk of intention-to-treat bias. Despite a nonsignificant reduction in mortality detected in patients with CKD stages 3-5 and not on dialysis treated with sevelamer versus CBBs, proof is lacking for an advantage of any phosphate binder over placebo in the predialysis setting ( 49 ).
Does sevelamer lower mortality?
Only in patients over 65 years of age was there a significant effect of sevelamer in lowering the mortality rate. There was a suggestion that sevelamer was associated with lower overall, but not cardiovascular-linked, mortality in older patients. We suggest that further research is needed to confirm these findings.
Does sevelamer cause calcification?
Elevated serum phosphorus and calcium are associated with arterial calcification and mortality in dialysis patients. Unlike calcium-based binders, sevelamer attenuates arterial calcification but it is unknown whether sevelamer affects mortality or morbidity.
How long are the sevelamer and calcium carbonate studies?
Each subject underwent two four-week study periods. During the "concomitant" period, subjects were instructed to take both sevelamer and calcium carbonate together at each meal, whereas in the "separate" period, they were required to take them at separate meals. The order of the "concomitant" and "separate" periods was randomized.
Is there a guideline for sevelamer and calcium carbonate?
There is no guideline regarding the concomitant or distant administration of sevelamer and calcium carbonate. Our aim was to determine whether serum phosphate varied when sevelamer and calcium carbonate were administered concomitantly in comparison to administration at separate meals. Fourteen chron …
What is Renvela?
Renvela (sevelamer) is a phosphate binder. Sevelamer helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.
What other drugs will affect Renvela?
Other drugs may interact with Renvela, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
How long after taking Renvela can you take Sevelamer?
Avoid taking any other medicines within 1 hour before or 3 hours after you take Renvela. Sevelamer can bind to other medications and make them less effective.
How old do you have to be to use Renvela?
Renvela is not approved for use by anyone younger than 6 years old.
Is Renvela safe for babies?
To make sure Renvela is safe for you, tell your doctor if you have: trouble swallowing; severe constipation; a blockage in your intestines; slow digestion; a stomach or intestinal disorder; or. if you have recently had stomach or intestinal surgery. It is not known whether this medicine will harm an unborn baby.
What to tell your doctor before taking Renvela?
Before taking Renvela, 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.
Can Renvela harm a baby?
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Your dose needs may be different during pregnancy. Taking Renvela while you are pregnant can lower your blood levels of certain vitamins or folic acid.
Indications and Usage For Renvela
Sevelamer is used to lower high blood phosphorus (phosphate) levels in patients who are on dialysis due to severe kidney disease.
May Treat: Renal osteodystrophy with hyperphosphatemia
Alternate Brand Names: Renagel
Drug Class: Phosphate Binders
Availability: Prescription Required
Pregnancy: Consult a doctor before using
May Treat: Renal osteodystrophy with hyperphosphatemia
Alternate Brand Names: Renagel
Drug Class: Phosphate Binders
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: GENZYME
- Take with meal(s) for better drug activity.
- Call Doctor right away if you get constipated
- It is important to follow an appropriate diet
- Take with meal(s) for better drug activity.
- Call Doctor right away if you get constipated
- It is important to follow an appropriate diet
- Skip missed dose unless you have just eaten.
- Lab tests may be ordered to monitor therapy
- Review all drugs you are taking with your doctor
- For powder in packet products : Mix drug in water and drink as directed. Tell doctor your complete medical history.
- For tablet products : Swallow whole. Do not break/chew/crush/dissolve. Do not use with feeding tube due to clogging.
Renvela Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
- General Dosing Information
Starting Dose for Adult Patients Not Taking a Phosphate Binder.The recommended starting dose of Renvela is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for adult patients not taking a phosphate bind… - Sevelamer Carbonate Powder Preparation Instructions
Sevelamer carbonate powder is available in 0.8 or 2.4 g packets. For dose increments of 0.4 g, use one half of a 0.8 g packet. Place the sevelamer carbonate powder in a cup and suspend in the amount of water described in Table 4. Instruct patients to stir the mixture vigorously (it does no…
Drug Interactions
- Tablets: 800 mg white oval, film-coated, compressed tablets imprinted with "Renvela 800" Powder: 0.8 g and 2.4 g pale-yellow powder packaged in an opaque, foil-lined, heat-sealed packet
Use in Specific Populations
- Renvela is contraindicated in patients with bowel obstruction. Renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
Overdosage
- 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 o… - Reductions in Vitamins D, E, K (clotting factors) and Folic Acid Levels
In preclinical studies in rats and dogs, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, 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, t…
Renvela Description
- Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. There are limited clinical trial da… - Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. The following adverse reactions have been identified during postapproval use of sevel…