NCCN Resource Tool: Risk Evaluation & Mitigation Strategies (REMS)

NCCN® has published updates to the NCCN Resource Tool: Risk Evaluation Mitigation Strategies (REMS) to reflect the recent FDA requirement to have a REMS program for Erythropoiesis-Stimulating Agents (ESAs). This NCCN Resource Tool provides oncology practitioners with a list of medications used for patients with cancer (i.e., for active treatment or supportive care) with one or more REMS components.

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NCCN Resource Tool: Risk Evaluation & Mitigation Strategies (REMS)

What are REMS?
Effective March 25, 2008, the Food and Drug Administration Amendments Act of 2007 (FDAAA) reserved the right for the U.S. 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.

There are three components to a REMS program:

1. a medication guide or a patient package insert
2. a communication plan for healthcare providers
3. elements to assure safe use (ETASU).

A drug’s REMS program may not require the provision of all three components, as the specific components a REMS program employs will vary based on the severity of the risks, the population likely to be exposed, and other factors. In fact, the most common REMS only require the provision of a medication guide.

While REMS components are not uniform, some do and will contain new provisions and requirements for physicians and other certified health care providers. For REMS requiring ETASU, clinicians may be required to:

º obtain and dispense drugs through specific distribution channels
º possess specific training, education, experience, or certification(s) in order to prescribe these drugs
º enroll patients in registry programs
º 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
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Active Treatment:
- Interferon alfa-2b (Intron A®) – Schering-Plough
º Melanoma, CML, Kidney cancer, Multiple myeloma, Neuroendocrine tumors, NHL, Sarcoma
º REMS component: medication guide

- Peginterferon alfa-2a (Pegasys®) – Hoffman-La Roche, Inc.
º CML
º REMS component: medication guide

- Peginterferon alfa-2b (PegIntron®) – Schering-Plough
º CML, Melanoma
º REMS component: medication guide

- Pazopanib (Votrient®) – GlaxoSmithKline
º Kidney cancer
º REMS component: medication guide


Supportive Care:
- Darbepoetin alfa (Aranesp®) – Amgen, Inc
º Anemia
º REMS component: medication guide, communication plan, elements to assure safe use, implementation system

- Epoetin alfa (Epogen®, Procrit®) – Amgen, Inc., Ortho Biotech Products, LP
º Anemia
º REMS component: medication guide, communication plan, elements to assure safe use, implementation system

- Eltrombopag (Promacta®) – GlaxoSmithKline
º Chronic Immune (Idiopathic) Thrombocytopenic Purpura
º REMS components: medication guide; elements to assure safe use; implementation system

- Fentanyl buccal soluble film (Onsolis®) – BioDelivery Sciences International, Inc. & Meda Pharmaceuticals Inc.
º Pain
º REMS components: medication guide; communication plan; elements to assure safe use; implementation system

- Morphine/naltrexone combination (Embeda®) – King Pharmaceuticals
º Pain
º REMS components: medication guide; communication plan

- Metoclopramide tablets, oral solution, and orally disintegrating tablets (Various generic, Reglan, Reglan ODT, Metozolv ODT) – Silarx Pharmaceuticals, Inc.; Morton Grove Pharmaceuticals, Inc.; Pharmaceutical Associates, Inc.; ANI Pharmaceuticals, Inc.; Salix Pharmaceuticals, Inc.; and Alaven Pharmaceutical, LLC
º Nausea and vomiting
º REMS component: medication guide

- Pancrelipase delayed-release capsules (Creon®, Zenpep®) – Solvay Pharmaceuticals, Inc.; Eurand Pharmaceuticals, Inc.
º Exocrine Pancreatic Insufficiency
º REMS component: medication guide

- Romiplostim (Nplate®) – Amgen, Inc.
º Chronic Immune (Idiopathic) Thrombocytopenic Purpura
º REMS components: medication guide; communication plan; elements to assure safe use; implementation system
http://www.nccn.org/rems/