FDA.reportPublic FDA data

Mycophenolate Mofetil - Belcher Pharmaceuticals LLC

Manufacturer
Belcher Pharmaceuticals LLC
Effective date
2023-11-28
Label type
RISK EVALUATION & MITIGATION STRATEGIES
Version
2
Source
full-release
Hydrated at
2026-06-04 22:50:37

Label at a glance#

ProductMycophenolate Mofetil
Label structure4 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Initial Shared System REMS Approval: 05/2023

II. REMS Goal

REMS GOALS

The goal of the PS-Mycophenolate REMS is to mitigate the risk of embryo-fetal toxicity associated with use of Mycophenolate during pregnancy by:

1. Educating healthcare providers on the following:

  • The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to Mycophenolate during pregnancy.
  • The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking Mycophenolate.
  • The need to report pregnancies to the PS-Mycophenolate Pregnancy Registry.

2. Informing females of reproductive potential who are prescribed Mycophenolate about:

  • The increased risks of pregnancy loss (miscarriage) and birth defects.
  • The importance of pregnancy prevention and planning when taking Mycophenolate.

III. REMS Requirements

REMS REQUIREMENTS

REMS Applicant Requirements

The PS-Mycophenolate Applicant(s) must provide training to healthcare providers who prescribe Mycophenolate.

The training must include all the elements of the FDA Blueprint.

For training provided by the PS-Mycophenolate Applicant(s), the training includes the following educational material: Healthcare Provider Guide.

For training provided by Continuing Education (CE) Providers, training is compliant with the REMS if it:

  • is offered by an accredited CE provider and supported by independent commercially-supported educational grants from the PS-Mycophenolate Applicant(s);
  • includes, at a minimum, a knowledge assessment of all sections of the FDA Blueprint; and
  • is subject to independent audit to confirm that conditions of the REMS training have been met.

To inform healthcare providers about the REMS and the risks and safe use of Mycophenolate, the PS-Mycophenolate Applicant(s) must disseminate REMS communication materials according to the table below:

Target Audience

Communication Materials & Dissemination Plans

Healthcare providers who prescribed Mycophenolate at least once in the 12 months prior to the date the first abbreviated new drug application (ANDA) is commercially available

REMS Letter: REMS Letter for Healthcare Providers 1

  1. Email within 60 calendar days of the date on which the first ANDA is commercially available. If a healthcare provider’s email address is not available, send by mail.
    1. For first emails marked unopened: Send a second email within seven (7) calendar days of the date the first email was sent.
    2. For second emails marked unopened: Send by mail within 30 calendar days of the date that the second email was sent.
    3. For emails that are undeliverable: Send by mail within 30 calendar days of the date that the first set of emails were sent.

REMS Letter: REMS Letter for Healthcare Providers 2

  1. Email when accredited continuing education is available and no later than 12 months following the date on which the first ANDA is commercially available. If a healthcare provider’s email address is not available, send by mail.
    1. For first emails marked unopened: Send a second email within seven (7) calendar days of the date the first email was sent.
    2. For second emails marked unopened: Send by mail within 30 calendar days of the date that the second email was sent.
    3. For emails that are undeliverable: Send by mail within 30 calendar days of the date that the first set of emails were sent.

All newly identified healthcare providers who prescribed Mycophenolate at least once in the 12 months after the date the first ANDA is commercially available

REMS Letter: REMS Letter for Healthcare Providers 1

  1. Email within 60 calendar days of the date the healthcare provider is newly identified from the date on which the first ANDA is commercially available until accredited continuing education is available. If a healthcare provider’s email address is not available, send by mail.
    1. For first emails marked unopened: Send a second email within seven (7) calendar days of the date the first email was sent.
    2. For second emails marked unopened: Send by mail within 30 calendar days of the date that the second email was sent.
    3. For emails that are undeliverable: Send by mail within 30 calendar days of the date that the first set of emails were sent.

REMS Letter: REMS Letter for Healthcare Providers 2

  1. After accredited continuing education is available: email within 60 calendar days of the date the healthcare provider is newly identified. If a healthcare provider’s email address is not available, send by mail.
    1. For first emails marked unopened: Send a second email within seven (7) calendar days of the date the first email was sent.
    2. For second emails marked unopened: Send by mail within 30 calendar days of the date that the second email was sent.
    3. For emails that are undeliverable: Send by mail within 30 calendar days of the date that the first set of emails were sent.

All transplant centers

REMS Letter: REMS Letter for Transplant Center Directors 1

  1. Mail within 60 calendar days of the date on which the first ANDA is commercially available.

REMS Letter: REMS Letter for Transplant Center Directors 2

  1. Mail when accredited continuing education is available and no later than 12 months following the date on which the first ANDA is commercially available.

Healthcare providers who are likely to prescribe Mycophenolate

Website Banner

Publish quarterly for 30 calendar days for the first 12 months after the date on which the first ANDA is commercially available, then every 6 months for 2 years through the following professional societies and their associated journals:

American College of Rheumatology, American Academy of Neurology, American Society of Transplantation, American Society of Nephrology, American College of Physicians, and American College of Obstetricians and Gynecologists

SPL UNCLASSIFIED SECTION

To support REMS operations, PS-Mycophenolate Applicant(s) must:

1. Establish and maintain a REMS website, www.psmycophenolaterems.com. The REMS website must include a current list of training funded by the PS-Mycophenolate Applicant(s) and the capability for healthcare providers to:

      a. confirm that they have completed training;

      b. order patient education materials; and

      c. print the Prescribing Information, Medication Guide, and REMS materials.

      All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS website. The REMS       website must not link back to the promotional product websites.

2. Make the REMS website fully operational and all REMS materials available through the    website and call center at the time that the first ANDA covered by this REMS becomes commercially available.

3. Establish and maintain a call center for REMS participants at 1-877-310-4015.

4. Direct CE Providers to the FDA Blueprint on: FDA_Mycophenolate_Blueprint_URL.

5. Ensure that healthcare providers are able to order the Patient Guide and PS-Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients online and by phone.

6. Ensure healthcare providers are able to access CE training no later than 12 months following the date on which the first ANDA covered by this REMS becomes commercially available.

7. Ensure healthcare providers are able to report completion of training online and by mail, email, and fax using the Prescriber Training Confirmation Form.

8. Ensure designees of transplant centers are able to report that healthcare providers at the center have completed training by mail, email, and fax using the Center Training Confirmation Form.

9. Establish and maintain a validated, secure database of all healthcare providers and centers that report completing training.

10. Monitor distribution and prescription data monthly to identify new Mycophenolate prescribers who need to be trained.

11. Notify accredited CE Providers of REMS-compliant training regarding changes to the FDA Blueprint within 10 calendar days of such changes.

12. Use independent auditors (accreditation bodies of CE Providers are considered independent and eligible to conduct the audits) to audit the educational materials used by the accredited CE Providers of REMS-compliant training funded by the PS-Mycophenolate Applicant(s) to evaluate:

      a. whether the content of the training addresses all the elements of the FDA Blueprint;

      b. whether the knowledge assessment measures knowledge of all sections of the FDA Blueprint;

      c. whether the training was conducted in accordance with the standards for commercially-supported CE of the Accreditation Council for          Continuing Medical Education or of another CE accrediting body appropriate to prescribers.

13. Establish and maintain a registry which includes a reporting and collection system for females who become pregnant and consent to participate to provide information on maternal and fetal outcomes.

14. Ensure that once a report suggestive of pregnancy is received, PS-Mycophenolate Applicant(s) follows up with the healthcare provider to obtain all required data for the registry.

IV. REMS Materials and text from the approved REMS document

REMS MATERIAL

The following materials are part of the PS-Mycophenolate REMS:

Training and Educational Materials

Healthcare Provider:

1. Healthcare Provider training available at www.psmycophenolaterems.com.

2. Healthcare Provider Guide

Patient:

3. Patient Guide

4. PS-Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients

Communication Materials

5. REMS Letter for Healthcare Providers 1

6. REMS Letter for Healthcare Providers 2

7. REMS Letter for Transplant Center Directors 1

8. REMS Letter for Transplant Center Directors 2

9. Website Banner

Other Materials

10. Program Website www.psmycophenolaterems.com Website Banner

11. Mycophenolate REMS Education Blueprint for Healthcare Providers Who Prescribe (FDA Blueprint)

12. Prescriber Training Confirmation Form

13. Center Training Confirmation Form

DailyMed Product Concepts#

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1aa45098-03f9-4bf8-b28d-2566aa0f7f4bProduct name120250218
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL FOR INJECTION safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL FOR INJECTION. MYCOPHENOLATE MOFETIL for injection, for intravenous use Initial U.S. Approval: 1995SPL related document2026-09-20BPI Labs LLC | Bioindustria Laboratorio Italiano Medicinali S.p.A20231130_ba13990d-dc38-4c0d-8a46-905ed807cf17.zip!6aa1af71-ca81-4979-be3a-245dc4633669.xml

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Matched openFDA labels page 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mycophenolate mofetilMYCOPHENOLATE MOFETILREMEDYREPACK INC.84c6f6bb-8924-4da5-9629-126197195f832026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
Mycophenolate mofetilMYCOPHENOLATE MOFETILStrides Pharma Inc.9d8c09fc-1df2-4f39-8e1a-c4b296d1a2602026-09-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
Mycophenolate MofetilMYCOPHENOLATE MOFETILTeva Pharmaceuticals USA, Inc.b414303f-e6f3-4e22-a537-96be352b59a42026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
mycophenolate mofetilMYCOPHENOLATE MOFETILAvPAKfbbe6521-0e21-5372-e053-6394a90ae5e42026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mycophenolate mofetil
Mycophenolate MofetilMYCOPHENOLATE MOFETILAmneal Pharmaceuticals LLC27fd9381-8d82-4187-897f-98f41f94e90f2026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
Mycophenolate MofetilMYCOPHENOLATE MOFETILA-S Medication Solutionsb4170ad9-67f0-42ea-b694-6b80824a607a2026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
Mycophenolate MofetilMYCOPHENOLATE MOFETILQUAGEN PHARMACEUTICALS LLC838449b3-4397-4e35-b9b9-683f5a48bff22026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
mycophenolate mofetilMYCOPHENOLATE MOFETILMajor Pharmaceuticals6abc5727-ee8e-43ad-ab39-0eef2feb257a2026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mycophenolate mofetil
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILREMEDYREPACK INC.d203775c-bf36-460c-bacf-3ab2348a514f2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILREMEDYREPACK INC.77a75d5b-a90d-4ee5-aa8a-6da97d1303572026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
Mycophenolate mofetilMYCOPHENOLATE MOFETILAscend Laboratories, LLC21ff53b0-b4ba-4473-91e4-76ef416810642026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
mycophenolate mofetilMYCOPHENOLATE MOFETILBryant Ranch Prepack0f1704e2-a66a-4be5-8127-ebb5947c7b642026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mycophenolate mofetil
Mycophenolate MofetilMYCOPHENOLATE MOFETILPar Health USA, LLC35ba0428-e267-49a5-99a9-c58853f7989d2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
mycophenolate mofetilMYCOPHENOLATE MOFETILAccord Healthcare Inc.741e079a-646b-47ec-84ac-8e12574c2aaf2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mycophenolate mofetil
Mycophenolate MofetilMYCOPHENOLATE MOFETILMeitheal Pharmaceuticals Inc.9650af9b-d36f-4a2f-9647-d0f7989334022026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
Mycophenolate MofetilMYCOPHENOLATE MOFETILAscend Laboratories, LLC9f84ea84-2d8b-4d91-a33f-7dfb5df937dc2026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
Mycophenolate mofetilMYCOPHENOLATE MOFETILMajor Pharmaceuticalsd176199c-dc3f-48c8-b7d2-c5d0a6a242fe2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate mofetil
Mycophenolate MofetilMYCOPHENOLATE MOFETILCamber Pharmaceuticals, Inc.c3ded171-89da-4644-9ee8-dbcf6258036f2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mycophenolate Mofetil
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILNorthStar Rx LLC127eabe2-8386-452a-ad6b-d879e1f2c0992026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILStrides Pharma Science Limitedc1c4cb31-00a7-417e-9775-24e849d627912025-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MYCOPHENOLATE MOFETIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.