Renvela 800 mg uses

Renvela

Generic Name: sevelamer (se VEL a mer)
Brand Names: Renagel, Renvela

Medically reviewed by Sanjai Sinha, MD Last updated on Mar 17, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Renvela?

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

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

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

Important information

You should not take Renvela if you have a bowel obstruction.

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.

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.

Before taking this medicine, 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.

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 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. 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. Follow your doctor’s instructions about taking vitamins or mineral supplements during pregnancy.

Because sevelamer is not absorbed into the bloodstream, it is not expected to be harmful to a nursing baby.

Renvela is not approved for use by anyone younger than 6 years old.

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 to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take Renvela with meals.

Renvela 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. Stir and drink this mixture right away. To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

While using sevelamer, you may need frequent blood tests.

Call your doctor if you have have trouble swallowing the tablet, or if it feels like it gets stuck in your esophagus after you swallow it.

Renvela 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.

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 day with meals.
Based on serum phosphorus level:
-Phosphorus greater than 5.5 to less than 7.5 mg/dL: 800 mg 3 times a day with meals
-Phosphorus greater than or equal to 7.5 to less than 9 mg/dL: 1200 to 1600 mg 3 times a day with meals
-Phosphorus greater than or equal to 9 mg/dL: 1600 mg 3 times a day with meals
-Titrate in increments of 800 mg 3 times a day at 2-week intervals with the goal of controlling serum phosphorus within target range.
Average prescribed dose: 7.2 g/day (2.4 g with each meal)
Maximum studied dose: 14 g per day (carbonate); 13 g per day (hydrochloride)
Switching from the hydrochloride salt to carbonate: Use the same dose, however further titration may be necessary to achieve desired phosphorus levels.
Switching from calcium acetate: Substitute approximately mg for mg
Comment: Treatment of hyperphosphatemia includes reduction in dietary intake of phosphate, inhibition of intestinal phosphate absorption with phosphate binders, and removal of phosphate with dialysis.
Use: To control serum phosphorus levels in patients with chronic kidney disease on dialysis.

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 scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

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 drugs, making them less effective:

  • ciprofloxacin (Cipro) should be taken at least 2 hours before or 6 hours after you take Renvela;

  • mycophenolate mofetil (CellCept) should be taken at least 2 hours before you take Renvela.

Renvela side effects

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

Stop using Renvela and call your doctor at once if you have:

  • choking, or trouble swallowing;

  • black, bloody, or tarry stools;

  • severe constipation with stomach pain; or

  • constipation that gets worse or does not clear up.

Common Renvela side effects may include:

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.

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.

Further information

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 10.02.

Medical Disclaimer

More about Renvela (sevelamer)

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  • Drug class: phosphate binders
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Consumer resources

  • Renvela (Sevelamer Powder Packets)
  • Renvela (Sevelamer Tablets)
  • Renvela (Advanced Reading)

Other brands: Renagel

Professional resources

  • Renvela (FDA)
  • … +1 more

Related treatment guides

  • Hyperphosphatemia of Renal Failure

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.

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.

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General Information

Renvela contains sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. 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 hydrogen bonding. By binding phosphate in the dietary tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum.

Renvela is specifically indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

Renvela is supplied as a tablet designed for oral administration. The recommended initial dose is as follows:
Patients Not Taking a Phosphate Binde:
Serum phosphorus >5.5 and <7.5 mg/dL: Renvela 800 mg 1 tablet three times daily with meals.
Serum phosphorus ≥7.5 and <9.0 mg/dL: Renvela 800 mg 2 tablets three times daily with meals.
Serum phosphorus ≥9.0 mg/dL Renvela 800 mg 2 tablets three times daily with meals.
Patients Switching from Sevelamer Hydrochloride
Sevelamer carbonate should be prescribed on a gram per gram basis. Further titration to the desired phosphate levels may be necessary. The highest daily dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.
Patients Switching From Calcium Acetate
The dose schedule of Renvela should match the dose schedule of the current calcium acetate dose. I.e. if current calcium acetate dose is 1 tablet per meal, the Renvela dose should be 1 tablet per meal.
Dose Titration for All Patients Taking Renvela
The dose should be increased or decreased by one tablet per meal at two week intervals, as necessary, with the goal of controlling serum phosphorus within the target range of 3.5 mg/dL to 5.5 mg/dL.

Clinical Results

FDA Approval
The FDA approval of Renvela was based on a double-blind, active controlled, cross-over study in 79 hemodialysis patients with two 8- week treatment periods. Stage 5 CKD patients on hemodialysis were entered into a five-week sevelamer hydrochloride run-in period and received, in random order, sevelamer carbonate 800 mg tablets and sevelamer hydrochloride 800 mg tablets for eight weeks each, with no intervening washout. Study dose during the cross-over period was determined based on the sevelamer hydrochloride dose during the run-in period on a gram per gram basis. The phosphate levels at the end of each of the two cross-over periods were similar. Average actual daily dose was 6 g/day for both treatments.

Side Effects

Adverse events associated with the use of Renvela may include, but are not limited to, the following:

  • Vomiting
  • Nausea
  • Diarrhea
  • Dyspepsia
  • Abdominal pain
  • Flatulence
  • Constipation

Mechanism of Action

Renvela contains sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. 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 hydrogen bonding. By binding phosphate in the dietary tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum.

Literature References

Fan S, Ross C, Mitra S, Kalra P, Heaton J, Hunter J, Plone M, Pritchard N A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association – European Renal Association 2009 Aug 7

Delmez J, Block G, Robertson J, Chasan-Taber S, Blair A, Dillon M, Bleyer AJ A randomized, double-blind, crossover design study of sevelamer hydrochloride and sevelamer carbonate in patients on hemodialysis. Clinical Nephrology 2007 Dec;68(6):386-91

Additional Information

For additional information regarding Renvela or elevated serum phosphorus in patients with chronic kidney disease on dialysis, please visit the Renvela web page.

How does this medication work? What will it do for me?

Sevelamer carbonate belongs to the class of medications called phosphate binders. Phosphate is made up mostly of the mineral phosphorus, which is an important component of normal bone structure, cell metabolism, and cell function.

In the body, the kidneys help keep the amount of phosphorus in the blood at a relatively constant level. For people with kidney problems, as their kidney function decreases, less phosphorus is removed from the body, potentially leading to a condition known as hyperphosphatemia (high phosphate levels in the blood). High levels of phosphorus in the blood can lead to problems with the strength and structure of bones. This condition is known as renal osteodystrophy.

When taken with meals, sevelamer carbonate prevents the absorption of phosphates from food by binding to the phosphate. It is used specifically to control high levels of phosphate (and therefore phosphorus) in the blood of people with severe kidney disease, known as end stage renal disease (ESRD), who are receiving dialysis (hemodialysis or peritoneal dialysis).

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each white, oval, film-coated tablet, imprinted with “RENVELA 800” contains 800 mg of sevelamer carbonate on an anhydrous basis. Nonmedicinal ingredients: microcrystalline cellulose, sodium chloride, and zinc stearate; coating: hypromellose and diacetylated monoglycerides; printing ink: hypromellose, iron oxide black ink, propylene glycol, and isopropyl alcohol.

How should I use this medication?

The dose of sevelamer carbonate depends on the amount of phosphorus that is present in the blood. The starting dose can range from 2.4 g to 4.8 g each day. Total daily doses of sevelamer carbonate is usually divided according to meal portions where higher doses of sevelamer carbonate are given with larger meals.

Your doctor may gradually increase the total daily dose of sevelamer carbonate according to the phosphorus level in your blood. Tablets should be taken immediately before meals or with meals. Do not bite, chew, or break apart the tablet before swallowing.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take sevelamer carbonate if you:

  • are allergic to sevelamer carbonate or to any of the ingredients of the medication
  • have a bowel obstruction
  • have low levels of phosphorus in your blood

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • diarrhea
  • headache
  • heartburn or indigestion
  • gas
  • itchiness
  • nausea
  • rash
  • vomiting

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • back or limb pain
  • difficulty swallowing
  • fever
  • signs of inflammation in the digestive system (e.g., pain in the lower left abdomen, fever, nausea, diarrhea or constipation)
  • upper respiratory tract infection (e.g., bronchitis, sinusitis)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of an allergic reaction (shortness of breath or difficulty breathing; hives; swelling of the eyes, mouth, lips, or throat)
  • signs of a blockage in the digestive system (e.g., abdominal cramping, gas pain, nausea, vomiting after meals, excessive burping)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Gastrointestinal disorders: If you have gastrointestinal disorders (e.g., dysphagia , severe disorders of movement in the gastrointestinal tract ) or you have had major gastrointestinal surgery, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low calcium: People with kidney disease may develop a condition called hypocalcemia (low calcium levels in the blood). While you are taking this medication, your doctor will regularly monitor your blood calcium levels. If you experience signs or symptoms of low blood calcium levels, such as muscle cramping or ache, dry skin or a feeling of pins and needles in your fingers, lips, tongue or feet, contact your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if sevelamer carbonate passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of using this medication have not been established for children and adolescents less than 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between sevelamer carbonate and any of the following:

  • calcitriol
  • levothyroxine
  • medication for an irregular heartbeat (antiarrhythmics; e.g., amiodarone, propafenone)
  • mycophenolate
  • phosphate containing medications or products
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • seizure medications (anticonvulsants; e.g., carbamazepine, phenytoin)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Renvela

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

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

To make sure sevelamer 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. Tell your doctor if you are pregnant or plan to become pregnant. Your dose needs may be different during pregnancy.

Taking sevelamer while you are pregnant can lower your blood levels of certain vitamins or folic acid. Follow your doctor’s instructions about taking vitamins or mineral supplements during pregnancy.

Because sevelamer is not absorbed into the bloodstream, it is not expected to be harmful to a nursing baby.

Sevelamer is not approved for use by anyone younger than 6 years old.

How should I take sevelamer (Renagel, Renvela)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take sevelamer with meals.

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. Stir and drink this mixture right away. To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

While using sevelamer, you may need frequent blood tests.

Call your doctor if you have have trouble swallowing the tablet, or if it feels like it gets stuck in your esophagus after you swallow it.

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.

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