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NCCN REMS Resource Webpage Updated

Edward C. Li, PharmD, BCOP, Drugs and Biologics Editor

To help oncology clinicians stay current with drugs requiring a Risk Evaluation and Mitigation Strategy (REMS), NCCN maintains a REMS Resource Page on its website to serve as a clinician reference tool. The REMS Resource Page lists agents used in oncology care that have a Food and Drug Administration (FDA)-approved REMS, including those used for active treatment and supportive care indications. The listings are comprised of the drug names (brand and generic), manufacturer, disease indications (according to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) and NCCN Drugs and Biologics Compendium (NCCN Compendium™), and required REMS components. Currently, there are twenty-three (23) drug listings on the page, eleven (11) of which require elements to assure safe use.

The NCCN REMS Resource Page was recently updated to include some drugs newly added to the FDA's list of approved REMS. The table summarized below reflects a sample of drugs recently added that may be used for a supportive care indication (e.g., pain, cancer-related fatigue) in a patient with cancer. All the drugs listed require the provision of a medication guide detailing the risks associated with these drugs whenever these agents are dispensed. Additionally, prescribing and dispensing the newly FDA-approved fentanyl sublingual tablets is contingent upon enrollment in the Abstral® REMS program.

 

Drug

Cancer-related use

REMS Element(s)

Date added

Gabapentin

Neuropathic pain

Medication guide

10/11/2010

Modafinil

Cancer-related fatigue

Medication guide

10/21/2010

Fentanyl sublingual tablets (Abstral®)

Pain

Medication guide, elements to assure safe use (Abstral REMS)

1/7/2011

 

 

 

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