Commitment to safety and patients: Risk Evaluation and Mitigation Strategies (REMS)

Bristol Myers Squibb is resolutely committed to patients, their families, providers and public health. We firmly believe that our commitment to developing the most effective Risk Evaluation and Mitigation Strategies (REMS) and our unwavering efforts to operate these systems has allowed hundreds of thousands of patients to access our medications while preventing certain serious risks associated with taking such medications. Our commitment to patients extends to ensuring, without exception, that other companies that utilize our products subject to REMS with Elements to Assure Safe Use (ETASU) in clinical testing share our commitment to safety and implement necessary safeguards.

Overview of REMS and ETASU

 

REMS are patient safety programs required by the U.S. Food and Drug Administration (FDA) that are intended to “ensure that the benefits of a drug or biological product outweigh its risks.”1Under the law, a REMS may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Since medicines are very different from each other, any required REMS is also different for each medicine. REMS elements can include a variety of safeguards including medication guides, patient package inserts, and communication outreach.1 Additionally, the FDA may require a REMS with more extensive requirements known as ETASU.2 Those elements can include required testing of patients before a medicine is administered, education of pharmacists and dispensing in certain health care settings.

In practice, a REMS program is a safety strategy that manages a known or potential serious risk associated with a medicine and enables patients to have access to such medicines by managing their safe use.

 

REMS with ETASU

 

Bristol Myers Squibb offers three legacy Celgene products with REMS programs that also include ETASU: Revlimid® (lenalidomide), Pomalyst® (pomalidomide) and Thalomid® (thalidomide). The goals of these REMS are to prevent the risk of embryo exposure to Revlimid, Pomalyst, and Thalomid and to inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for these drugs.

The FDA originally approved Thalomid® with a risk management program because of the severe consequences associated with fetal exposure to the product. Although this medicine is beneficial to patients with a serious fatal disease, it comes with great risks. Even a single dose of thalidomide, the active ingredient in Thalomid®, can cause irreversible, debilitating birth defects. These severe birth defects were at the center of a worldwide health crisis in the 1950s and 1960s, and were the reason that the FDA did not approve the use of thalidomide until the 1990s, and even then, not until a strict risk management plan was in place. Celgene worked with the FDA to find a way to authorize use of thalidomide in a safe and responsible manner for patients with serious unmet medical needs, developing a risk management system that strictly regulates the distribution of thalidomide from beginning to end.

Since 1998, when the FDA approved thalidomide with these rigorous controls, access to thalidomide for tens of thousands of patients with Erythema Nodosum Leprosum (ENL), a skin condition caused by leprosy, or newly diagnosed multiple myeloma has been provided without an incident of a severe birth defect. We also implemented the same rigorous controls for the distribution of Revlimid® and Pomalyst®, which are believed to have similar risks.

REMS program and requirements are designed to protect the public health and further our strong interest on behalf of patients in ensuring that these products are used only under safe conditions.

Were it not for the development of REMS programs with ETASU for these products, it is unlikely that these medicines would have ever been made available to patients.

Sale of Testing Samples to Generic Companies

 

Celgene has sold and Bristol Myers Squibb will sell these groundbreaking products to generic manufacturers for the purposes of bioequivalence testing, subject to reasonable safety-related and business requirements. Generic versions of Thalomid® and Revlimid® are licensed to enter the market in coming years, and manufacturers have filed numerous Abbreviated New Drug Applications (ANDAs) for generic versions of our medicines.

Commitment to Safety

 

Bristol Myers Squibb is resolutely committed to patients, their families, providers and public health. To date, there have been no reported congenital malformations associated with our products in over one million prescription cycles. We firmly believe that our commitment to developing highly effective REMS programs and our unwavering efforts to operate these systems have allowed hundreds of thousands of patients to access these medications while preventing the serious risks associated with embryo-fetal toxicities.

As of October 2020, there are 59 products with FDA-authorized REMS programs. Of those 59 products, 51 require “Elements to Assure Safe Use” (ETASU). 3 

Please click here for Full Prescribing Information, including Boxed Warnings, for REVLIMID
Please click here for Full Prescribing Information, including Boxed Warnings, for POMALYST. 
Please click here for Full Prescribing Information, including Boxed Warnings, for THALOMID

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REMS - Pharmacy Network

The REMS – Pharmacy Network list includes specialty pharmacies that are contracted to fill prescriptions for restricted distribution programs for legacy Celgene products including REVLIMID, POMALYST and THALOMID. All pharmacies listed are certified to dispense all legacy Celgene REMS products.

Updated:  September 2020

Pharmacy Phone Fax
Absolute Pharmacy 787‐892‐8700 787‐496‐1010
Accredo Specialty Pharmacy 877-732-3431 800-590-1021
ACS Advanced Care Scripts  877-985-6337 866-679-7131
AllianceRx Walgreens Prime 888-347-3416 877-231-8302
Amber Specialty Pharmacy 888‐370‐1724 877‐645‐7514
Axium Healthcare Puerto Rico 787‐780‐7200 800‐546‐2163
Biologics by McKesson 800‐850‐4306 800‐823‐4506
Biomatrix 888‐662‐6779 877‐800‐4790
BioPlus Specialty Pharmacy 888‐292‐0744 800‐269‐5493
CareMed Specialty Pharmacy 877-227-3405 877-542-2731
CVS Specialty 
800-237-2767 800-323-2445
Diplomat Specialty Pharmacy 877-977-9118 800-550-6272
Exactus Pharmacy Solutions, Inc. (WellCare) 866-458-9246 866-458-9245
Farmacia San Rafael 787‐724‐3333 787‐721‐4165
Humana Specialty Pharmacy 800-486-2668 877-405-7940
Kroger Specialty Pharmacy 888‐327‐2962 888-315-3270
Magellan Rx Pharmacy (ICORE) 866-554-2673 866-364-2673
Onco360 877-662-6633 877-662-6355
Optum Specialty Pharmacy 888‐432‐2797 866‐306‐5231
RxCrossroads by McKesson (VA Dispensing) 855‐637‐9433 855‐637‐9446
Special Care Pharmacy Services 787‐783‐8579 787‐783‐2951
Upstate Pharmacy 800‐314‐4655 800‐314‐7756
US Bioservices 877-757-0667 888-899-0067

References:

  1. FDCA §505-1(e)(2)
  2. FDCA §505-1(f)(3)
  3. U.S. Food & Drug Administration. REMS Reports. Available at https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsData.page.