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Risk Evaluation & Mitigation Strategies (REMS)

What are REMS?

Effective as of March 25, 2008, The Food and Drug Administration Amendments Act of 2007 (FDAAA) reserved the right for the Food and Drug Administration (FDA) to order Risk Evaluation & Mitigation Strategies (REMS) for drugs or biologics with significant toxicity levels and/or demonstrable risk factors. These strategies are meant to ensure that the benefits of particular drugs continue to outweigh the risks that they pose for patients. REMS are currently being mandated to assess adverse risks associated with specific oncologic drugs, biologics and supportive care therapies.
While REMS components are not uniform, many do and will contain new provisions and requirements for physicians and other certified health care providers. Clinicians may be required to:

• obtain and dispense drugs through specific distribution channels
• possess specific training, education, experience, or certification(s) in order to prescribe these drugs
• enroll patients in registry programs
• issue mandatory, time-sensitive reports of patient responses to treatment

Your ability to prescribe and dispense certain medications, even some that have been on the market for years, could be contingent upon compliance with these REMS provisions.

For a comprehensive list of FDA approved REMS, please visit: FDA Approved REMS

Active Disease Treatment:

• Melanoma
• Interferon Alfa-2b (INTRON®A) – Schering Corporation

• Multiple Myeloma
• Lenalidomide (Revlimid®) – Celgene Corporation
• Thalidomide (Thalomid®) – Celgene Corporation

• Prostate
• Abarelix (Plenaxis™) – GlaxoSmithKline Inc.

Supportive Care:

• Chronic Immune (Idiopathic) Thrombocytopenic Purpura
• Romplostim (Nplate®) – Amgen Inc.

• Erythropoiesis-Stimulating Agents (ESAs)
• Darbepoetin Alfa (Aranesp®) – Amgen Inc.
• Epoetin Alfa (Epogen®) – Amgen Inc.
• Epoetin Alfa (Procrit®) – Centocor Ortho Biotech, LP.

• Exocrine Pancreatic Insufficiency
• Pancrelipase (Creon®)—Solvay Pharmaceuticals

• Pain Management
• BEMA Fentanyl (ONSOLIS®) – BioDelivery Sciences International, Inc. & Meda Pharmaceuticals Inc.
• Fentanyl Buccal Tablet (FENTORA®) – Cephalon Inc.
• Fentanyl citrate oral transmucosal lozenge (Actiq®) – Cephalon Inc.

• Paroxysmal Nocturnal Hemoglobinuria
• Eculizumab (Soliris®) – Alexion Pharmaceuticals

For REMS patient information on NCCN.com, please click here

Companies interested in supporting a link to REMS Information should contact C. Lyn Fitzgerald, Director, Pharma/Biotech.