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Drugs reference index «Renvela»

Renvela

Generic Name: sevelamer (Oral route)

se-VEL-a-mer

Commonly used brand name(s):

In the U.S.

  • Renagel
  • Renvela

Available Dosage Forms:

  • Tablet
  • Powder for Suspension
  • Capsule

Therapeutic Class: Phosphate Binder

Uses For Renvela

Sevelamer is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with chronic kidney disease who are on dialysis.

This medicine is available only with your doctor's prescription.

Before Using Renvela

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sevelamer in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sevelamer in the elderly.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ciprofloxacin
  • Levothyroxine
  • Mycophenolate Mofetil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bowel blockage—Should not be used in patients with these conditions.
  • Difficulty with swallowing or other swallowing problems or
  • Hypophosphatemia (low phosphorus in the blood) or
  • Major surgery on the gastrointestinal tract or
  • Stomach or bowel problems (e.g., constipation), severe—Use with caution. May make these conditions worse.

Proper Use of sevelamer

This section provides information on the proper use of a number of products that contain sevelamer. It may not be specific to Renvela. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take this medicine with meals.

Swallow the capsule whole. Do not break or chew the capsule before swallowing.

Do not open up the capsules before taking them. The medicine inside may swell if it comes in contact with water.

Follow carefully any diet program your doctor may recommend.

How to use the powder for oral suspension:

  • Pour the entire contents of the packet in an empty cup.
  • Mix the powder with 30 or 60 milliliters (mL) of water.
  • Stir the mixture and drink it within 30 minutes.

If you are taking any other medicines, take them at least one hour before or three hours after you take sevelamer. If you need help deciding the best times to take your other medicines, ask your doctor or pharmacist.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For high phosphorus levels in the blood:
    • For oral dosage form (capsules):
      • Adults not taking a phosphate binder—At first, the dose is usually between 2 and 4 capsules three times a day depending on how high your blood phosphorus level is. Your doctor may adjust your dose as needed.
      • Adults switching from calcium acetate to sevelamer—At first, the dose is generally between 2 and 5 capsules three times a day depending on how many tablets of calcium acetate you are currently taking. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage forms (suspension or tablets):
      • For patients not taking a phosphate binder:
        • Adults—At first, 1 to 2 tablets or 0.8 to 1.6 grams (g) three times a day depending on your blood phosphorus level. Your doctor may adjust your dose as needed. However, the dose is usually not more than 7.2 g per day.
        • Children—Use and dose must be determined by your doctor.
      • For patients switching from calcium acetate to sevelamer:
        • Adults—At first, 1 to 3 tablets per meal or 0.8 to 2.4 grams (g) three times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 7.2 g per day.
        • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Renvela

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve or if they get worse, call your doctor.

Many people with kidney problems need to be on a special diet. To keep your kidney disease from getting worse, it is very important that you follow your special diet and take your medicines regularly, even if you are feeling better.

Renvela Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Bloody, black, or tarry stools
  • heartburn
  • indigestion
  • nausea
  • severe abdominal or stomach pain, cramping, or burning
  • severe constipation
  • severe vomiting
  • trouble breathing
  • vomiting
  • vomiting of material that looks like coffee grounds, severe and continuing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • bloating
  • constipation
  • diarrhea
  • excess air or gas in the stomach or intestines
  • full feeling
  • passing gas
  • stomach discomfort or upset
Incidence not known
  • Itching skin
  • rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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  • Renvela Prescribing Information (FDA)
  • Renvela MedFacts Consumer Leaflet (Wolters Kluwer)
  • Renvela Consumer Overview
  • Sevelamer Professional Patient Advice (Wolters Kluwer)
  • Renagel Consumer Overview
  • Renagel Prescribing Information (FDA)

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