Patient Medication Information: uses, side effects, how to take - Renvela (Sanofi-Aventis Canada, 800 mg)
Serious warnings and precautions box
What RENVELA is used for:
RENVELA is used to treat high levels of phosphorous in the blood, in patients who have end-stage renal disease and are undergoing dialysis. RENVELA is for use in adults and children (6 years of age and older, with a Body Surface Area of 0.75 m2 or greater).
How RENVELA works:
RENVELA is a ‘phosphate binder’. When taken with meals, RENVELA attaches to ingested phosphate molecules and stops them from being absorbed into your body. The RENVELA and phosphate are then carried together and removed from the body in your stools. This helps to lower the amount of phosphorus in your blood.
The ingredients in RENVELA are:
Medicinal ingredient: Sevelamer carbonate
Non-medicinal ingredients: Diacetylated monoglycerides, hypromellose, microcrystalline cellulose, sodium chloride, zinc stearate.
RENVELA comes in the following dosage form:
Tablet; 800 mg
Do not use RENVELA if:
- you have low phosphorus levels
- RENVELA may cause serious side effects that may require hospitalization and surgery. Tell your healthcare professional or go to the hospital right away if you have difficulty swallowing, bowel obstruction, or bowel perforation.
- you have bowel obstruction/blockage, or have known active damage to the lining of the digestive tract such as necrosis (death of tissue), perforation (hole), ulcers (sores) or bleeding.
- you are allergic to sevelamer carbonate or to any of the other ingredients in the product
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RENVELA. Talk about any health conditions or problems you may have, including if you:
- have difficulty swallowing, any swallowing disorders or problems with your esophagus. This includes children, who may find it hard to swallow tablets.
- have any intestinal disorders, such as conditions that slow down the passage of food through the intestine and lead to blockage.
- have had surgery on your intestines.
- have severe or worsening constipation
- have low calcium levels in your blood.
are pregnant, plan to become pregnant or are nursing
Other warnings you should know about:
Monitoring and tests: Before and during your treatment with RENVELA, your healthcare professional may perform tests to check your:
- bicarbonate and chloride levels
- calcium levels
- vitamin D, E, K and folic acid levels
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with RENVELA:
- ciprofloxacin, an antibiotic used to treat bacterial infections.
- levothyroxine, used to treat hypothyroidism (an underactive thyroid).
- cyclosporin, mycophenolate mofetil and tacrolimus, immunosuppressants used to prevent organ transplant rejection.
- proton pump inhibitors, used to treat stomach ulcers (e.g., pantoprazole, omeprazole).
- medications used to treat abnormal heart rhythms (anti-arrhythmics).
- medications used to control seizure disorders (anti-seizure medications).
How to take RENVELA:
- RENVELA is only available as a tablet. Swallowing tablets can present a choking hazard to younger children. Only take RENVELA if you can swallow tablets whole.
- Take RENVELA exactly as your healthcare professional has told you to.
- Take RENVELA three times a day, always take it with food (a meal and/or snacks).
- Swallow tablets whole, do NOT crush, chew or break the tablet.
Usual dose:
Your healthcare professional will tell you how much RENVELA to take and when to take it. They may adjust your dose to find the amount that is right for you. Your dose depends on your phosphorus levels. In children, the dose also depends on Body Surface Area.
Overdose:
If you think you, or a person you are caring for, have taken too much RENVELA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you miss a dose, skip it and take your next dose at the regular scheduled time, with food. Do NOT take a double dose to make up for a missed dose.
Possible side effects from using RENVELA:
These are not all the possible side effects you may have when taking RENVELA. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- nausea
- vomiting
- diarrhea
- indigestion
- constipation
- stomach pain
- rash
- itch
- flatulence (gas)
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Common | |||
| Abdominal pain | ✓ | ||
| Uncommon | |||
| Dysphagia (difficulty swallowing): problems with food or liquids | ✓ | ||
| moving from the mouth to the stomach. A feeling of food getting stuck, pain, coughing, problems with your esophagus | |||
| Bowel Obstruction (ileus) (blockage that stops or impairs passage of contents through the intestines): stomach bloating, pain, swelling or cramps, constipation, blood in stools, vomiting | ✓ | ||
| Gastrointestinal perforation (tear or hole in the wall of the stomach or intestine): sudden severe abdominal pain, swelling and or bloating of the stomach area, nausea, vomiting, fever and chills | ✓ | ||
| Unknown | |||
| Diverticulitis (inflammation of sacs in the intestines): left lower stomach pain, fever, nausea, diarrhea, or constipation | ✓ | ||
| Allergic reactions: difficulty breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat | ✓ | ||
Inflammation of the bowel: severe abdominal pain, stomach or intestine problems, blood in the stool | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store the tablets at controlled room temperature 15°C to 30°C. Protect from moisture and heat.
Keep out of reach and sight of children.
If you want more information about RENVELA:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.sanofi.com/en/canada); or by calling 1-800-265-7927.
Date of Authorization: 2026-04-17