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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).

Sevelamer carbonate—the authorized generic identical to Renvela®

Winthrop US is a Sanofi company dedicated to delivering brand-equal generics of Sanofi products, including Renvela.

The truth behind generics

What is a generic drug? A generic drug is a copy of a brand-name drug that is made by a company other than the company that makes the brand-name. A generic drug is the same as the brand-name drug in terms of active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling. However, a generic drug may have certain minor differences from the brand-name product, such as different inactive ingredients or tablet size.

In contrast, an authorized generic drug is the exact same in all aspects as a brand-name drug, except that it is marketed without the brand name on its label.

Choosing Winthrop US sevelamer carbonate ensures that you will get the exact same drug product as branded Renvela.

Winthrop US's sevelamer carbonate uses the same manufacturing process as Renvela. It is identical to Renvela in shape, active ingredients, size, and inactive ingredients.

Affordable solutions

From the earliest stages of development to batch release, Winthrop US is dedicated to providing affordable solutions to the healthcare community. Sevelamer carbonate comes with all the quality of Renvela along with the cost savings of generics.

Learn more about Winthrop US

See more details about the authorized generic sevelamer carbonate, as well as the other products Winthrop US has to offer.

Find Out More

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, upset stomach, abdominal pain, flatulence, and constipation.
  • Cases of itching, rash, fecal impaction and, less commonly, slow bowel activity, bowel obstruction, 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 frequently occurring side effects with sevelamer carbonate tablets include nausea and vomiting.
  • Side effects with sevelamer carbonate powder taken three times a day are similar to those reported for sevelamer carbonate tablets.
  • 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, and bowel perforation have been reported.
  • Uncommon cases of difficulty swallowing with 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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