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 Prescriber Training Confirmation Form to document that you understand, and will comply with Mycophenolate REMS.

You can submit a 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/email it to:

    Mycophenolate REMS
          200 Pinecrest Plaza
          Morgantown, WV 26505-8065
          support@mycophenolateREMS.com
  • Call 1-800-617-8191

Step 2 - Educate Females of Reproductive Potential
Step 3 - Check Pregnancy Status
Step 4 - 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 providers are not required to complete the Prescriber Training Confirmation Form in order to prescribe mycophenolate-containing medicines. However, healthcare providers who prescribe mycophenolate-containing medicines will be contacted by the Mycophenolate REMS and encouraged to become trained. This training could include reading the Prescribing Information and the Healthcare Provider Brochure.
Your REMS Materials:
 
   
Patient Information Brochure: What You Need To Know About Mycophenolate
  • For prescribers to give to female patients of reproductive potential
  • Contains the tools and materials to help patients understand the components of the Mycophenolate REMS
 
 

 
   
Healthcare Provider 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
 
 

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

 
   
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 CapsuleMycophenolate MofetilConcord Biotech Limited Medication Guide
Mycophenolate Mofetil Capsule/TabletMycophenolate MofetilHikma Pharmaceuticals USA Inc. Medication Guide
Mycophenolate Mofetil CapsuleMycophenolate MofetilHisun Pharmaceuticals USA, Inc. Medication Guide
Mycophenolate Mofetil TabletMycophenolate MofetilHisun Pharmaceuticals USA, Inc. 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 Capsule/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 for Oral SuspensionMycophenolate MofetilVistaPharm, Inc. Medication Guide
Mycophenolate Mofetil Injection, Powder, Lyophilized, for SolutionMycophenolate MofetilZydus Pharmaceuticals (USA) Inc. Medication Guide
Mycophenolic Acid Tablet, Delayed ReleaseMycophenolic AcidAccord Healthcare, Inc. Medication Guide
Mycophenolate Sodium Tablet, Delayed ReleaseMycophenolic AcidApotex Corp. Medication Guide
Mycophenolic Acid Tablet, Delayed ReleaseMycophenolic AcidMylan Pharmaceuticals Inc. Medication Guide
Mycophenolic Acid Tablet, Delayed ReleaseMycophenolic AcidTeva Pharmaceuticals USA, Inc. Medication Guide
Mycophenolate Mofetil TabletMycophenolate MofetilConcord Biotech Limited Medication Guide
Mycophenolate Mofetil for Injection, USPMycophenolate MofetilMylan Pharmaceuticals Inc. Medication Guide
Mycophenolate Mofetil for Injection USPMycophenolate MofetilMeitheal Pharmaceuticals Inc. Medication Guide
Mycophenolate Mofetil for Injection USPMycophenolate MofetilAmneal Pharmaceuticals LLC Medication Guide
Mycophenolic Acid Tablet, Delayed ReleaseMycophenolic AcidAMTA LABS LIMITED Medication Guide

The Mycophenolate Applicants attest that this page will only include Medication Guides from the list of approved application numbers and applicants on the FDA approved REMS website.