Renvela

Last updated on RxList: 6/30/2021
Renvela Side Effects Center

What Is Renvela?

Renvela (sevelamer carbonate) is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis.

What Are Side Effects of Renvela?

Common side effects of Renvela include:

Dosage for Renvela

The starting dose of Renvela is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients and based on Body Surface Area (BSA) category for pediatric patients. The dose is adjusted by 0.8 g per meal in two-week intervals for adult patients as needed to obtain the serum phosphorus target.

What Drugs, Substances, or Supplements Interact with Renvela?

Renvela may interact with other oral medications taken at the same time, ciprofloxacin, and mycophenolate mofetil. Tell your doctor all medications and supplements you use.

Renvela During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Renvela; Renvela is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Breastfeeding is not expected to result in exposure of the child to Renvela. Consult your doctor before breastfeeding.

Additional Information

Our Renvela (sevelamer carbonate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

The only purpose of the kidneys is to filter blood. See Answer
Renvela Consumer Information

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Get emergency medical help if you have 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:

  • 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 side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;
  • upset stomach, gas, bloating;
  • diarrhea, 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 entire detailed patient monograph for Renvela (Sevelamer Carbonate)

SLIDESHOW

Kidney Stones: Symptoms, Causes, and Treatment See Slideshow
Renvela Professional Information

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 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 data on the safety of Renvela. However, because it contains the same active ingredient as the hydrochloride salt, the adverse event profiles of the two salts are expected to be similar. In a cross-over study in hemodialysis patients with treatment durations of eight weeks each and no washout, and another cross-over study in hemodialysis patients, with treatment durations of four weeks each and no washout between treatment periods, the adverse reactions on sevelamer carbonate powder were similar to those reported for sevelamer hydrochloride.

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-comparator 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 sevelamer hydrochloride was gastrointestinal adverse reactions (3-16%).

In 143 peritoneal dialysis patients studied for 12 weeks using sevelamer hydrochloride, most common 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 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.

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 post-approval use of sevelamer hydrochloride or sevelamer carbonate: 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.

Read the entire FDA prescribing information for Renvela (Sevelamer Carbonate)

© Renvela Patient Information is supplied by Cerner Multum, Inc. and Renvela Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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