Approved Risk Evaluation and Mitigation Strategies (REMS)

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Saxenda (liraglutide)
NDA #206321
REMS last update: 05/22/2017



What is the purpose of the REMS?

The goal of the SAXENDA REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with SAXENDA by:

  1. Informing healthcare providers about the potential risk of medullary thyroid carcinoma associated with SAXENDA
  2. Informing healthcare providers about the risk of acute pancreatitis (including necrotizing pancreatitis) associated with SAXENDA.

What do participants need to know?

Healthcare providers should read the relevant Medication Guide or communication materials included in the product-specific approved REMS to learn about the risk(s). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

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. For a specific Medication Guide of a product in the Saxenda REMS, see the DailyMed link(s).
Material Name Material Name Link
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Document.pdf
REMS Factsheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Factsheet.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_Full.pdf
REMS Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Letter_for_Healthcare_Providers.pdf
REMS Letter for Professional Societies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Letter_for_Professional_Societies.pdf
REMS Slides (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Slides.pdf
REMS Website Screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Saxenda_2017-05-22_REMS_Website_Screenshot.pdf

What updates have been made to the REMS?

Date Summary of change
05/22/2017 Modified to align with the changes to the Saxenda prescribing information approved with NDA 206321/S-003 on September 22, 2016 in the REMS document and REMS materials.
02/01/2016 Modified to include a link to the Saxenda REMS website on www.saxenda.com, www.saxendacare.com, and www.saxendapro.com.
12/23/2014 Approval of the REMS.

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.

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