INFORMATION FOR PRESCRIBERS
What is my role in the Mycophenolate REMS? Click step to expand details.
Step 1 - Document your training in the Mycophenolate REMS

You should become familiar with the risks of embryofetal toxicity associated with mycophenolate and the requirements of Mycophenolate REMS:

  • First-trimester pregnancy loss
  • Congenital malformations, especially
    • external ear
    • cleft lip and palate abnormalities
  • Anomalies of
    • the distal limbs
    • heart
    • esophagus
    • kidney
    • and nervous system
As a prescriber of mycophenolate, you should document your training in the Mycophenolate REMS by completing a Mycophenolate REMS Prescriber Training Confirmation Form to document that you understand, and will comply with Mycophenolate REMS.
You can submit a Mycophenolate REMS Prescriber Training Confirmation Form to Mycophenolate REMS by one of several ways:
  • Visit www.MycophenolateREMS.com and complete the online form
  • Complete a hard copy and submit it via fax to 1-800-617-5768
  • Complete a hard copy and mail it to:

    Mycophenolate REMS
          200 Pinecrest Plaza
          Morgantown, WV 26505-8065
  • Call 1-800-617-8191

Step 2 - Educate Females of Reproductive Potential
Step 3 - Obtain a signed Patient-Prescriber Acknowledgment form
Step 4 - Check Pregnancy Status
Step 5 - Report any pregnancies to the Mycophenolate Pregnancy Registry


Do prescribers have to be trained in the Mycophenolate REMS in order to prescribe mycophenolate-containing products?
Healthcare professionals are not required to complete the Mycophenolate REMS Prescriber Training Confirmation Form in order to prescribe mycophenolate-containing medicines. However, healthcare professionals who prescribe mycophenolate-containing medicines will be contacted by the Mycophenolate REMS Program and encouraged to review the program materials and complete a Mycophenolate REMS Prescriber Training Confirmation Form (online or paper).
Your Program Materials:
 
   
Mycophenolate REMS Patient Brochure: What You Need To Know About Mycophenolate
 
 

 
   
Mycophenolate REMS Patient-Prescriber Acknowledgment Form
  • For prescribers to give to female patients of reproductive potential
  • Female patients of reproductive potential must sign this to acknowledge that they will comply with program requirements
  • The Mycophenolate REMS Patient Brochure: What You Need To Know About Mycophenolate also contains a Mycophenolate REMS Patient-Prescriber Acknowledgment form
 
 

 
   
Mycophenolate REMS Healthcare Providers Brochure
  • For prescribers
  • Contains information on the risks associated with exposure to mycophenolate during pregnancy, the components of the Mycophenolate REMS, and what you can do to help ensure the successful implementation of the program.
 
 

 
   
Mycophenolate REMS Dear Healthcare Provider (DHCP) Letter
  • For prescribers
  • Contains important information about the Mycophenolate REMS
 
 

 
   
Mycophenolate REMS Dear Healthcare Provider (DHCP) Letter for Centers
  • For healthcare centers
  • Contains important information about the Mycophenolate REMS for healthcare centers
 
 

 
   
Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients
  • For prescribers to give to female patients of reproductive potential
 
 

 
   
Mycophenolate REMS Prescriber Training Confirmation Form
  • For prescribers
  • This form can be used to document training in the Mycophenolate REMS. The form can be filled out and mailed or faxed to document your training.
 
 

Generic Medication Guides

Drug NameGeneric NameCompanyLinks
Mycophenolate Mofetil Capsule/TabletMycophenolate MofetilAccord Healthcare, Inc. Medication Guide
Mycophenolate Mofetil for Injection, USPMycophenolate MofetilAkorn, Inc. Medication Guide
Mycophenolate Mofetil Capsule/TabletMycophenolate MofetilAlkem Laboratories, Ltd. Medication Guide
Mycophenolate Mofetil powder, for suspensionMycophenolate MofetilAlkem Laboratories, Ltd. Medication Guide
Mycophenolate Mofetil Capsule/TabletMycophenolate MofetilApotex Corp. Medication Guide
Mycophenolate Mofetil Capsule/TabletMycophenolate MofetilJubilant Cadista Pharmaceuticals Inc. Medication Guide
Mycophenolate Mofetil Capsule/TabletMycophenolate MofetilMylan Pharmaceuticals, Inc. Medication Guide
Mycophenolate Mofetil for Injection, USPMycophenolate MofetilPar Pharmaceutical. Medication Guide
Mycophenolate Mofetil Capsule/TabletMycophenolate MofetilStrides Pharma Inc. Medication Guide
Mycophenolate Mofetil CapsuleMycophenolate MofetilSandoz Incorporated Medication Guide
Mycophenolate Mofetil TabletMycophenolate MofetilSandoz Incorporated Medication Guide
Mycophenolate Mofetil Capsule/TabletMycophenolate MofetilTeva Pharmaceuticals USA, Inc. Medication Guide
Mycophenolate Mofetil CapsuleMycophenolate MofetilVintage Pharmaceuticals, LLC. Approved, but not currently marketed
Mycophenolate Mofetil TabletMycophenolate MofetilVintage Pharmaceuticals, LLC. Approved, but not currently marketed
Mycophenolate Mofetil Capsule/TabletMycophenolate MofetilWest-Ward Pharmaceuticals Corp. Medication Guide
Mycophenolate Sodium Tablet, Delayed ReleaseMycophenolate AcidApotex Corp. Medication Guide
Mycophenolate Acid Tablet, Delayed ReleaseMycophenolate AcidMylan Pharmaceuticals, Inc. Medication Guide