Issues related to Isotretinoin use in Oncology
The FDA and the pharmaceutical companies that make 13-cis-retinoic acid (isotretinoin or Accutane) have implemented a new system for controlling prescriptions called iPLEDGE. It is important that any physician who will be prescribing isotretinoin be registered with iPLEDGE. The iPLEDGE team and the FDA are working with the pediatric oncology community to solve problems to insure drug access for all oncology patients. Information on issues related to iPLEDGE and neuroblastoma can be found here on this web site.
The iPLEDGE system can sometimes introduce unacceptable delays in getting access to isotretinoin for patients with cancer. iPLEDGE has created a form so that physicians prescribing isotretinoin for cancer patients can seek exceptions to some of the automated restrictions imposed by iPLEDGE. This can only be used for cancer patients, and can be used for requesting an oncology exception for a variety of reasons, when medically justified.
Call iPLEDGE at 877-475-3345 if you need any assistance with the exception request. This phone number is not staffed with a live operator, please leave contact information and the call will be returned. Please note that this phone number must only be used for requesting exceptions for oncology patients. No other iPLEDGE questions or issues will be handled through this number.
Click on the links below to download.
- iPledge Letter to Healthcare Providers re. Elimination of the 23 day lock-out period for Males and Females of Non-Childbearing Potential - Adobe PDF document
- Oncology Exception Instructions - MS Word document
- Form to Request Oncology Exception - MS Word document
- December 2005 Memo From Children's Oncology Group on iPLEDGE - Adobe PDF document