Renvela

Your doctor may instruct you to follow a low-phosphorus diet. Follow these directions carefully. Talk to your doctor about foods that contain high amounts of phosphorus.

>10%

Vomiting (22%)

Nausea (20%)

Diarrhea (19%)

Dyspepsia (16%)

Nasopharyngitis (14%)

Limb pain (13%)

Pruritus (13%)

Arthralgia (12%)

Bronchitis (11%)

Dyspnea (10%)

Hypertension (10%)

1-10%

Abdominal pain (9%)

Constipation (8%)

Flatulence (8%)

Peritonitis (during peritoneal dialysis: 8%)

Hypercalcemia (5-7%)

Frequency Not Defined

Back pain

Cough

Headache

Pyrexia

Upper respiratory infection

Pruritus

Rash

Intestinal perforation

Fecal impaction

Intestinal obstruction

Postmarketing Reports

Hypersensitivity

• Extraneal

Read the Renvela User Reviews »

© 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.

Serious side effects have been reported with Renvela. See “Renvela Precautions” section.

Common side effects of Renvela include:

• vomiting
• nausea
• diarrhea
• upset stomach
• pain in the stomach area (abdomen)
• gas
• constipation
• itching
• rash

This is not a complete list of Renvela side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Renvela, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of swallowing disorders, digestive tract surgery, severe constipation, or intestinal blockage
• are allergic to Renvela
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended starting dose of Renvela (sevelamer) is 0.8 or 1.6 grams taken three times per day, with meals.

The dose can be increased in order to obtain serum phosphorus target (3.5 to 5.5 mg/dL) or the target indicated 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 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.

In the U.S.

• Renagel
• Renvela

Available Dosage Forms:

• Tablet
• Powder for Suspension
• Capsule

Therapeutic Class: Phosphate Binder

Pharmacologic Class: Bile Acid Sequestrant

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 postapproval 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.

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:

• 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.