Renvela Tablet (Sevelamer Carbonate) | Phosphate Binder for High Phosphorus in Chronic Kidney Disease
Renvela Tablet contains Sevelamer Carbonate, a phosphate binder used to control elevated blood phosphorus levels in people with chronic kidney disease who are on dialysis. It works in the digestive tract by binding dietary phosphate and reducing its absorption.
Product Overview
Renvela Tablet contains Sevelamer Carbonate, a non-absorbed phosphate binder used to help control serum phosphorus levels in patients with chronic kidney disease (CKD) who are receiving dialysis. The current U.S. prescribing information includes adults and children 6 years of age and older.
When taken with meals, Sevelamer Carbonate binds phosphate present in food inside the gastrointestinal tract. The resulting complex is not absorbed into the body and is eliminated through the digestive system. This reduces the amount of phosphate absorbed from food and helps lower serum phosphorus levels.
Because Renvela works by binding phosphate from food, it should be taken with meals according to the prescribed schedule. The dose is adjusted based on blood phosphorus levels and the patient's medical needs.
Key Product Information
| Product Information | Details |
| Product Name | Renvela Tablet |
| Active Ingredient | Sevelamer Carbonate |
| Medicine Type | Phosphate Binder |
| Dosage Form | Film-Coated Tablet |
| Route | Oral |
| Primary Use | Control of serum phosphorus |
| Medical Condition | Chronic Kidney Disease on Dialysis |
| Main Action | Binds dietary phosphate in the gastrointestinal tract |
| Administration | Taken with meals |
| Monitoring | Serum phosphorus and other relevant blood parameters |
How Renvela Works
Sevelamer Carbonate remains in the gastrointestinal tract and binds phosphate from food. Because the medicine is not systemically absorbed, the phosphate-bound complex passes through the digestive system and is eliminated in the stool. This reduces dietary phosphate absorption and helps control serum phosphorus.
Role in Chronic Kidney Disease
The kidneys normally remove excess phosphorus from the blood. In advanced CKD, particularly in people receiving dialysis, phosphorus can accumulate in the body. Renvela is used as part of the dietary and medical management of elevated serum phosphorus in these patients.
Precaution
Gastrointestinal Problems
Tell your healthcare professional if you have difficulty swallowing, severe constipation, gastrointestinal motility problems, or a history of major gastrointestinal surgery. Sevelamer has been associated with serious gastrointestinal complications, including bowel obstruction, ulcers, inflammation, bleeding, perforation, and tissue damage.
Difficulty Swallowing
Renvela tablets should be used carefully in people who have swallowing difficulties. Cases of difficulty swallowing and retention of the tablet in the esophagus have been reported. A suspension formulation may be considered in appropriate patients.
Bowel Obstruction
Renvela is contraindicated in patients with bowel obstruction. Tell your healthcare professional if you have symptoms suggesting blockage or significant changes in bowel movements.
Blood Phosphorus Monitoring
Serum phosphorus levels should be monitored during treatment. The dose may need to be adjusted according to laboratory results and the prescribed treatment plan.
Vitamins and Folic Acid
Sevelamer may reduce the absorption of certain nutrients, including vitamins D, E, and K and folic acid. Your healthcare professional may monitor nutritional status and recommend supplementation when appropriate.
Allergic Reactions
Do not use Renvela if you have a known hypersensitivity to Sevelamer Carbonate, Sevelamer Hydrochloride, or any of the ingredients in the product.
Other Medicines
Tell your doctor or pharmacist about all prescription medicines, over-the-counter products, vitamins, and supplements you take. Sevelamer can bind certain medicines in the gastrointestinal tract and may affect their absorption.
Pregnancy and Breastfeeding
Tell your healthcare professional if you are pregnant, planning to become pregnant, or breastfeeding. Your doctor can determine whether Renvela is appropriate based on your individual medical situation.
Usage
Renvela Tablet should be taken with meals and exactly as prescribed by your healthcare professional. The dose is determined according to serum phosphorus levels, previous phosphate-binder treatment, age, and other clinical factors.
For adults who are not already taking a phosphate binder, the current U.S. prescribing information lists a starting dose of 0.8 to 1.6 g with meals, depending on the serum phosphorus level. The dose may then be adjusted at intervals based on blood phosphorus results. This information should not be used to determine an individual dose.
Swallow the tablets as directed. Do not crush, chew, or break the tablet unless your healthcare professional specifically instructs you to do so.
If you miss a dose, follow the instructions provided by your healthcare professional. Do not take an extra dose to compensate unless specifically instructed.
Uses
1. Control of High Blood Phosphorus
Renvela is used to control elevated serum phosphorus levels in people with chronic kidney disease who are receiving dialysis.
2. Phosphate Management in Chronic Kidney Disease
It helps reduce the amount of dietary phosphate absorbed from food by binding phosphate in the gastrointestinal tract.
3. Phosphorus Control in Adults on Dialysis
Renvela is indicated for adults with chronic kidney disease who are on dialysis and require treatment to control serum phosphorus.
4. Phosphorus Control in Children on Dialysis
The current U.S. labeling also includes children 6 years of age and older with chronic kidney disease who are receiving dialysis.
5. Dietary Phosphate Management
Renvela can be used as part of a broader medical and dietary plan for managing phosphorus levels in dialysis patients.
Side Effects
Renvela may cause side effects, particularly gastrointestinal symptoms. Not everyone experiences these effects.
Common Side Effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Indigestion or dyspepsia
- Abdominal discomfort
- Abdominal bloating or distension
- Stomach pain
Gastrointestinal reactions are among the most commonly reported adverse effects associated with Sevelamer treatment.
Serious Side Effects
Seek prompt medical attention if you develop:
- Severe or persistent abdominal pain
- Severe constipation or inability to pass stool
- Significant abdominal swelling
- Difficulty swallowing
- Persistent vomiting
- Black or bloody stools
- Symptoms of intestinal blockage
- Severe allergic reactions
Serious gastrointestinal events, including bowel obstruction, gastrointestinal bleeding, ulceration, necrosis, colitis, and perforation, have been reported with sevelamer products.
FAQs
1. What is Renvela Tablet used for?
Renvela Tablet contains Sevelamer Carbonate and is used to control serum phosphorus levels in adults and children 6 years and older with chronic kidney disease who are on dialysis.
2. What is the active ingredient in Renvela Tablet?
The active ingredient is Sevelamer Carbonate, a non-absorbed phosphate binder.
3. How does Renvela work?
Renvela binds phosphate from food in the gastrointestinal tract, reducing phosphate absorption into the bloodstream. The bound phosphate is then eliminated through the stool.
4. When should Renvela be taken?
Renvela is taken with meals because it needs to bind dietary phosphate in the digestive tract. Follow the schedule prescribed by your healthcare professional.
5. Can Renvela be taken without food?
Renvela is intended to be taken with meals. Taking it separately from meals may reduce its ability to bind dietary phosphate.
6. Does Renvela lower phosphorus levels?
Yes. Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.
7. Can Renvela cause constipation?
Yes. Constipation is a reported gastrointestinal side effect. Severe or persistent constipation should be discussed with a healthcare professional because serious gastrointestinal complications have been reported with sevelamer.
8. Can Renvela interact with other medicines?
Yes. Sevelamer can bind certain medicines in the digestive tract and affect their absorption. Ciprofloxacin and mycophenolate mofetil are examples for which separate administration may be required.
Interactions
Renvela Tablet contains Sevelamer Carbonate, which works inside the gastrointestinal tract by binding phosphate. Because it can also bind certain medicines taken by mouth, it may reduce the absorption or exposure of some medicines. Inform your doctor or pharmacist about all prescription medicines, over-the-counter products, vitamins, and supplements you are taking before starting Renvela.
Ciprofloxacin
Sevelamer can reduce the absorption of ciprofloxacin. The medicines should not be taken at the same time. Ciprofloxacin should generally be taken at least 2 hours before or 6 hours after Renvela, according to prescribing information.
Mycophenolate Mofetil
Sevelamer can reduce exposure to mycophenolic acid, the active metabolite of mycophenolate mofetil. Mycophenolate mofetil should generally be administered at least 2 hours before Renvela to reduce the potential for this interaction.
Levothyroxine
Postmarketing reports have described increased thyroid-stimulating hormone (TSH) levels when sevelamer was used with levothyroxine. If these medicines are used together, your healthcare professional may recommend separating their administration and monitoring thyroid function.
Cyclosporine and Tacrolimus
Sevelamer may reduce exposure to cyclosporine or tacrolimus. This is particularly important in patients receiving these medicines after transplantation. If used together, appropriate monitoring of medicine levels and clinical response may be required.
Other Oral Medicines
For medicines where reduced absorption could have an important effect on treatment, your healthcare professional may recommend separating the timing of Renvela and the other medicine. The appropriate separation depends on the specific medicine and its absorption characteristics.
Medicines With No Demonstrated Pharmacokinetic Interaction
Studies have found that sevelamer did not significantly alter the pharmacokinetics of digoxin, enalapril, iron, metoprolol, or warfarin when administered together. However, your healthcare professional should still review your complete medication list because individual treatment requirements may differ.
Vitamins and Supplements
Sevelamer may reduce the absorption of certain fat-soluble vitamins, including vitamins A, D, and K, as well as folic acid. People taking Renvela may require monitoring of nutritional status and appropriate supplementation when recommended by their healthcare professional.
| Manufacturer | : | Taj Pharma India Ltd. |
| Equivalent Brand | : | Renvela |
| Generic Search | : | sevelamer carbonate |
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