Approved Risk Evaluation and Mitigation Strategies (REMS)

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Tanzeum (albiglutide)
BLA #125431
REMS last update: 07/27/2015



What is the purpose of the REMS?

The goal of the TANZEUM REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis associated with TANZEUM by:

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

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 Tanzeum REMS, see the DailyMed link(s).
Material Name Material Name Link
Letter for Healthcare Professionals (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_Letter_for_Healthcare_Providers.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_document.pdf
REMS factsheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_factsheet.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_full.pdf
REMS website screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tanzeum_2015.07.27_REMS_website_screenshot.pdf

What updates have been made to the REMS?

Date Summary of change
07/27/2015 Modified to conform the REMS to the safety labeling changes approved on March 9, 2015, under sBLA No. 008, by making changes in the REMS document and to the following REMS appended materials: REMS Letter for Healthcare Providers, REMS Letter for Professional Societies, REMS Factsheet, and the REMS Webpage.
04/15/2014 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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