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

 

View all Drugs with REMS for:

 

Search by Drug Name:

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:

  • 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 Treatment:

  • Interferon alfa-2b (Intron A®) – Schering-Plough
    • Released from REMS on 5/13/2011
  • Ipilimumab (Yervoy®) – Bristol-Myers Squibb
    • REMS components: communication plan
  • Isotretinoin – Barr Laboratories, Inc., Mylan Pharmaceuticals Inc., Ranbaxy Labs Inc.
    • REMS components: medication guide, elements to assure safe use, implementation system
  • Lenalidomide (Revlimid®) – Celgene Corporation
    • REMS components: elements to assure safe use, implementation system
  • Nilotinib (Tasigna®) – Novartis Pharmaceuticals
    • Released from REMS on 5/17/2013
  • Peginterferon alfa-2a (Pegasys®) – Hoffman-La Roche, Inc.
    • Released from REMS on 5/09/2011
  • Peginterferon alfa-2b (PegIntron®) – Schering-Plough
    • Released from REMS on 5/13/2011
  • Pazopanib (Votrient®) – GlaxoSmithKline
    • Released from REMS on 4/21/2011
  • Pomalidomide (Pomalyst®) – Celgene Corporation
    • REMS components: elements to assure safe use, implementation system
  • Ponatinib (Iclusig®) Tablets – ARIAD Pharmaceuticals, Inc.
    • REMS component: communication plan
  • Sunitinib (Sutent®) – Pfizer, Inc.
    • Released from REMS on 5/19/2011
  • Thalidomide (Thalomid®) – Celgene Corporation
    • REMS component: elements to assure safe use, implementation system
  • Vandetanib (Caprelsa®) – AstraZeneca Pharmaceuticals LP
    • REMS component: medication guide, communication plan, elements to assure safe use, implementation system

Supportive Care:

  • Denosumab (Prolia®) – Amgen, Inc.
    • REMS components: medication guide, communication plan
  • Epoetin alfa (Epogen®, Procrit®) – Amgen, Inc., Janssen Products, LP
    • REMS components: elements to assure safe use, implementation system
    • To enroll in the ESA APPRISE Oncology Program , please visit www.esa-apprise.com
  • Eltrombopag (Promacta®) – GlaxoSmithKline 
    • REMS components: communication plan
  • Fentanyl buccal soluble film (Onsolis®) – BioDelivery Sciences International, Inc. & Meda Pharmaceuticals Inc.
    • REMS components: medication guide, elements to assure safe use, implementation system
  • Fentanyl buccal tablet (Fentora®) – Cephalon, Inc.
    • REMS components: medication guide, elements to assure safe use, implementation system
  • Fentanyl buccal transmucosal (Actiq®) – Cephalon, Inc.
    • REMS components: medication guide, elements to assure safe use, implementation system
  • Fentanyl nasal spray (Lazanda®) – Depomed, Inc. (formerly Archimedes Pharma)
    • REMS components: medication guide, elements to assure safe use, implementation system
  • Fentanyl sublingual spray (SUBSYS®) – Insys Therapeutics
    • REMS components: medication guide, elements to assure safe use, implementation system
  • Fentanyl sublingual tablets (Abstral®) - Galena Biopharma
    • REMS components: medication guide, elements to assure safe use, implementation system
  • Gabapentin (Neurontin®) – Pfizer Inc.
    • Released from REMS on 8/10/2011
  • Hydromorphone hydrochloride extended release tablets (Exalgo®) – Mallinckrodt, Inc.
    • REMS components: medication guide, elements to assure safe use
  • Morphine sulfate oral solution (10 mg/5 mL, 20 mg/5 mL, 100 mg/5 mL) – Roxane Laboratories, Inc.
    • Released from REMS on 10/18/2011
  • Morphine/naltrexone combination (Embeda®) – King Pharmaceuticals
    • 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
    • REMS component: medication guide
    • Tablets and orally disintegrating tablets released from REMS on 8/02/2011 (Reglan® and Reglan® ODT) and 8/22/2011 (Metozolv® ODT)
  • Modafinil (Provigil®) – Cephalon, Inc.
    • Released from REMS on 1/13/2012
  • Oxycodone controlled-release tablets (OxyContin®) – Purdue Pharma L.P.
    • REMS components: medication guide, elements to assure safe use
  • Pancrelipase delayed-release capsules (Creon®, Pancreaze®, Zenpep®) – Solvay Pharmaceuticals, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Eurand Pharmaceuticals, Inc.      
    • Released from REMS on 5/09/2011 (Creon®), 6/10/2011 (Zenpep®), and 6/20/2011 (Pancreaze®)
  • Romiplostim (Nplate®) – Amgen, Inc.
    • REMS components: communication plan

 


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

Companies interested in supporting a link to REMS Information should contact
Marisa Getzewich, Manager, Business Development.