View the Myalept Prescribing Information at DailyMed
REMS last update: 11/28/2016
View Myalept's Regulatory Information at Drugs@FDA
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
Healthcare Providers who prescribe Myalept
|To be able to prescribe Myalept||
|Before writing the first prescription for a patient||
|Before writing each prescription after the first prescription||
Patients who receive Myalept
|Before receiving the initial Myalept prescription||
Pharmacies that dispense Myalept
|To be able to dispense Myalept||
|Before dispensing Myalept||
What materials are included in the REMS?
The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:
Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.