INFORMATION FOR OTHER HEALTHCARE PROFESSIONALS
What do I need to know about the Mycophenolate REMS? Click step to expand details.
Step 1 - Understand the Increased Risks of Mycophenolate Use During Pregnancy

You should become familiar with the increased risks of embryofetal toxicity associated with mycophenolate:

  • 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

Step 2 - Counsel Females of Reproductive Potential
Step 3 - Report Pregnancies


Program Resources and Educational Materials
The Mycophenolate REMS provides the resources and educational materials you need to understand the program and counsel patients.

You can view, print, or save the materials to your computer. Select items from the list below.

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
 
 

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

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.


*Sifontis NM, et al. Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus. Transplantation. 2006;82:1698-1702.
†Prescribing Information for mycophenolate.