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Patient Representation for Renvela (sevelamer carbonate) treatment

An Important Announcement From

RENASSIST will not reopen in 2018, but will remain open through December 21, 2017.

See Important Dates

Indication

Renvela® (sevelamer carbonate) is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.

Renagel® (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

Important Safety Information

Do not use Renvela or Renagel if you have a history of bowel obstruction or if you are allergic to sevelamer carbonate or sevelamer hydrochloride or to any of the ingredients in Renvela or Renagel.

Click here for additional Important Safety Information.

Please see Full Prescribing Information for Renvela (PDF) or Full Prescribing Information for Renagel (PDF). Please see Full Prescribing Information for Sevelamer Carbonate (PDF).

Renvela® for Oral Suspension Powder Video

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Open the packet by tearing or cutting along the top.

Sevelamer carbonate powder is available in 0.8 or 2.4 g packets.

For dose increments of 0.4 g, use one half of a 0.8 g packet. Place the sevelamer carbonate powder in a cup and suspend in the amount of water as described in the preparation instructions.

The number of packets you should use will depend on the instructions that were given to you by your doctor or other healthcare provider. If your prescription calls for more than one packet, you may mix multiple packets together in the same container. For example, mix one 2.4-gram packet with 2 ounces of water, or two 2.4- gram packets with 4 ounces of water, and so on.

[Dietician to Patient]: Let me have you add this Renvela powder into the 2 ounces of water.

[Patient]: O.K.

[Dietician to Patient]: Perfect.

Now stir the mixture vigorously, keeping in mind, it does not dissolve.

Resuspend, if necessary, right before administration, and drink the entire preparation within 30 minutes.

As an alternative to water, the entire contents of the sachet may be pre-mixed with a small amount of food or beverage and consumed immediately (within 30 minutes) as part of the meal.

Do not heat Renvela Powder, such as microwaving, or add to heated foods or liquids.

 

Preparing Renvela powder

  • Renvela should be taken
    • 3 times per day with meals
    • As directed by your doctor
  • 2 ounces of water measured into a cup
  • Entire packet of the 2.4g Renvela poured into the cup.
  • The mixure of water and Renvela powder being stirred
  1. 1Measure a minimum of 2 ounces of water into a cup for a 2.4g packet of Renvela.
    • 2 ounces = 4 tablespoons = ¼ measuring cup
    • A larger amount of water may be needed, based on the dose of Renvela powder prescribed by your healthcare provider.
  2. 2 Open the Renvela packet.
    • Tear or cut it along the top and pour the entire packet into the cup of water.
  3. 3 Stir the mixture thoroughly.
    • Note that the powder will not dissolve completely, so the mixture will be cloudy.
  4. 4 Drink the entire mixture within 30 minutes.
    • Be sure to stir vigorously just before drinking.
  5. 5 Take Renvela with kidney-friendly and low-phosphorus meals.
    • Work with your healthcare team to develop a low–phosphorus eating plan. Get new ideas and helpful tips from the Patient Resource Library.
  • How to prepare a 2.4 g packet of Renvela powder with food or beverage:
    • Entire content from Renvela powder getting poured into the food
    • Entire content from Renvela powder mixed with food
    1. 1Pre-mix the entire contents of the packet with a small amount of food or beverage and consume immediately (within 30 minutes) as part of the meal. Do not heat Renvela Powder (e.g. microwave) or add to heated foods or liquids.
    • Patients should take Renvela with low-phosphorus meals.

      Renvela®

      Indication

      Renvela® (sevelamer carbonate) is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.

      Renagel® (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

      Important Safety Information

      • Do not use Renvela or Renagel if you have a history of bowel obstruction or if you are allergic to sevelamer carbonate or sevelamer hydrochloride or to any of the ingredients in Renvela or Renagel.
      • Talk to your doctor if you have had difficulty swallowing or swallowing disorders; or if you have had digestive tract surgery or other digestive disorders, including severe constipation.
      • The most common side effects with sevelamer include vomiting, nausea, diarrhea, indigestion, abdominal pain, flatulence, and constipation.
      • Cases of itching, rash, fecal impaction and, less commonly, slow bowel activity, bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis and bowel perforation have been reported.
      • Uncommon cases of difficulty swallowing the Renagel or Renvela tablet have been reported. Talk to your doctor if you have difficulty swallowing medicines in tablet form. Renvela powder for oral suspension may be considered by your doctor if you have a history of difficulty swallowing.
      • Your doctor should monitor bicarbonate and chloride blood levels.
      • Reduced vitamins D, E, and K (clotting factors) and folic acid blood levels may be followed by your doctor.
      • Talk to your doctor when taking sevelamer with other medications.
      • Promptly contact your doctor if you experience severe abdominal pain, new or worsening constipation, or other severe intestinal symptoms while on sevelamer.
      • Take sevelamer with meals and adhere to your prescribed diet

      Sevelamer Carbonate

      Indication

      Sevelamer carbonate is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.

      Important Safety Information

      • Do not use sevelamer carbonate if you have a history of bowel obstruction or if you are allergic to sevelamer carbonate, sevelamer hydrochloride or to any of the ingredients.
      • Talk to your doctor if you have had difficulty swallowing or swallowing disorders; or if you have had digestive tract surgery or other digestive disorders, including severe constipation.
      • The most common side effects with sevelamer include vomiting, nausea, diarrhea, indigestion, abdominal pain, flatulence, and constipation.
      • Cases of itching, rash, fecal impaction and, less commonly, slow bowel activity, bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis and bowel perforation have been reported.
      • Uncommon cases of difficulty swallowing the sevelamer carbonate tablet have been reported. Talk to your doctor if you have difficulty swallowing medicines in tablet form. Sevelamer carbonate for oral suspension may be considered by your doctor if you have a history of difficulty swallowing.
      • Your doctor should monitor your bicarbonate and chloride blood levels.
      • Reduced vitamins D, E, and K (clotting factors) and folic acid blood levels may be followed by your doctor.
      • Talk to your doctor when taking sevelamer carbonate with other medications.
      • Promptly contact your doctor if you experience severe abdominal pain, new or worsening constipation, or other severe intestinal symptoms while on sevelamer carbonate.
      • Take sevelamer carbonate with meals and adhere to your prescribed diet.

      Please see Full Prescribing Information for Renvela (PDF) or Full Prescribing Information for Renagel (PDF).
      Please see Full Prescribing Information for Sevelamer Carbonate (PDF).
      Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.

      The health information contained herein is provided for general education purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment.

      Dear Customer,

      Sanofi recently launched its own authorized generic of Renvela (sevelamer carbonate). This means that, in addition to branded Renvela (sevelamer carbonate), patients can now access Sanofi’s authorized generic sevelamer carbonate, depending on their plan coverage.

      Due to the change in the market, the need for patient support services has changed. Renassist will remain open through December 21, 2017, but will not reopen in 2018. What this means for healthcare professionals and patients:

      • Multiple Patient Submissions will be accepted through December 1, 2017.
      • Insurance verification requests will be accepted through December 15, 2017.
      • New Renvela Patient Assistance Applications (uninsured patients) will be accepted through December 1, 2017.
        • Patients eligible for refills for this program will be accepted through December 15, 2017.
      • 2017 Part D Assistance Program will close November 15, 2017.
        • Patients eligible for refills for this program will be accepted through December 15, 2017.
      • RenValue card will continue to be available to eligible patients in 2018 where permitted by law.

      We would like to thank you for allowing us to support your patients over the years.

      Sincerely,

      The Team

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