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Renassist Patient Assistance Program (RPAP)


What is RPAP?

RPAP is designed for patients in financial need who do not have coverage for
Renvela® (sevelamer carbonate) (and/or Hectorol® (doxercalciferol) injection) under any prescription drug benefit, including commercial insurance, Medicare, Medicaid, or other government insurance programs.

Through a partnership with the American Kidney Fund (AKF), Sanofi provides qualifying patients with medication at no cost.


Who is eligible for assistance through RPAP?

  • Patients who do not have existing drug coverage for Renvela® and/or Hectorol® under any prescription drug benefit, including commercial insurance, Medicare, Medicaid, or other government insurance programs
  • US citizens or legal residents
    • A copy of Green Card or Permanent Resident Card is required for legal residents
  • Patients in the 90-day waiting period for Medicare coverage
Financial eligibility is based on the patient's monthly household income, expenses, and total assets, and is determined by the AKF.

What documentation is required?

  • A Renassist® Insurance Verification Form and Patient Assistance Application (PDF) must be completed and submitted to Renassist via fax or email.
  • Use the Application Assistant to complete an application by clicking here
  • Medicare A and B beneficiaries having household income below 150% of the Federal Poverty Level who are applying for Renvela® (sevelamer carbonate) or Hectorol® (doxercalciferol injection) assistance must include one of the following:
    • Official notice of denial or the predecisional notice for the Low-Income Subsidy (Extra Help) from the Social Security Administration
    • If applicant is a legal resident, a copy of his/her Green Card or Permanent Resident Card

What is the enrollment process?

  • All applications are submitted to Renassist for review of insurance status, and then forwarded to AKF for financial review.
    • The healthcare professional and/or the patient will be contacted by fax or phone if an application is incomplete or requires additional information. Please note: incomplete applications will be returned.
  • AKF will send an approval or denial letter to the dialysis unit by mail or email.
  • Medication will be filled by EnvoyHealth in up to a 3-month supply with a maximum of 3 refills through the RPAP grant approval date for patients who continue to meet the program criteria.

Is there a need for reenrollment?

  • Qualified applicants are required to reapply 1 year from the date the prescription was written.
  • Should the patient or healthcare provider have questions regarding the refill process, please contact Renassist.
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Click here for Ferrlecit Important Safety Information and Full Prescribing Information

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Click here for Hectorol Important Safety Information and Full Prescribing Information

Indication
Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride) are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

Important Safety Information
  • Sevelamer is contraindicated in patients with bowel obstruction.
  • Caution should be exercised in patients with dysphagia, swallowing disorders, and severe gastrointestinal (GI) motility disorders, including severe constipation or major GI tract surgery.
  • Common adverse events reported with sevelamer include vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation. Other events reported include pruritus, rash, fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation.
  • Uncommon cases of difficulty swallowing the Renagel or Renvela tablet have been reported. Caution should be exercised in these patients and consideration given to using Renvela suspension in patients with a history of difficulty swallowing.
  • Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take sevelamer.
  • Serum bicarbonate and chloride levels should be monitored.
  • Follow patients for reduced vitamins D, E, and K (coagulation parameters) and folic acid levels.
  • Patients should be informed to take sevelamer with meals and to adhere to their prescribed diets.

Please click here for full Prescribing Information for Renvela (PDF) or full Prescribing Information for Renagel (PDF).

Indication
Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride) are used to control phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

Important Safety Information
  • Do not use sevelamer if you have a history of bowel obstruction.
  • 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.

Please click here for full Prescribing Information for Renvela (PDF) or full Prescribing Information for Renagel (PDF).

Indication
  • Hectorol (doxercalciferol) Injection is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
  • Hectorol capsules are indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease not on dialysis and patients with chronic kidney disease on dialysis.

Important Safety Information
  • Hectorol is contraindicated in patients with a tendency towards hypercalcemia, or evidence of vitamin D toxicity.
  • Overdosage of any form of vitamin D is dangerous and may lead to progressive hypercalcemia, which if severe, may require emergency attention.
  • Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs.
  • Chronic hypercalcemia can lead to generalized vascular and other soft tissue calcification.
  • Pharmacologic doses of vitamin D and its derivatives should be withheld during Hectorol treatment to avoid possible additive effects and hypercalcemia.
  • The patient should be informed about adherence to instructions about diet, calcium supplementation, and avoidance of the use of nonprescription drugs without prior physician approval. Patients should also be carefully informed about the symptoms of hypercalcemia such as weakness, headache, drowsiness, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste and loss of appetite.
  • Uncontrolled serum phosphorus in patients undergoing dialysis may lessen the effectiveness of Hectorol.
  • Magnesium-containing antacids and Hectorol should not be administered concomitantly.
  • Patients should be checked and treated for nutritional vitamin D deficiency prior to initiating treatment with Hectorol capsules.
  • Cholestyramine may impair intestinal absorption of doxercalciferol capsules.
  • Enzyme inducers may affect the 25-hydroxylation of Hectorol and may necessitate dosage adjustments. Cytochrome P450 inhibitors may inhibit the 25-hydroxylation of Hectorol. Formation of the active Hectorol moiety may be hindered.
  • Adverse effects of Hectorol injection treatment are: hypercalcemia, hyperphosphatemia, and oversuppression of iPTH. Adverse effects of Hectorol capsules treatment are hypercalcemia, hyperphosphatemia, hypercalciuria, and oversuppression of PTH. These should be managed by regular patient monitoring and appropriate dosage adjustments.
  • Serum levels of iPTH, calcium and phosphorus should be determined prior to initiation of Hectorol treatment. During the early phase of treatment they should be determined weekly.
  • Adverse events reported by ≥5% of the Hectorol-treated dialysis patients included: edema, headache, malaise, nausea/vomiting, dizziness, dyspnea, pruritus and bradycardia.
  • Adverse events occurring at a frequency of ≥5% in patients taking Hectorol capsules with Stage 3 or Stage 4 chronic kidney disease not on dialysis were infection, chest pain, constipation, dyspepsia, anemia, dehydration, depression, hypertonia, insomnia, paresthesia, increased cough, dyspnea and rhinitis.
  • This drug should be used during pregnancy only if clearly needed.
  • Nursing mothers should discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  • This drug should be used with caution in patients with impaired hepatic function.

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