Approved Risk Evaluation and Mitigation Strategies (REMS)

Contact Us | REMS Basics | Gov Delivery Get REMS Email Alerts | Reports & Data Files

Zydelig (idelalisib)
NDA #206545 NDA #205858
REMS last update: 01/04/2017



What is the purpose of the REMS?

The goal of the Zydelig REMS is to mitigate the risks of fatal and /or serious hepatotoxicity; fatal and/or serious and severe diarrhea or colitis; fatal and/or serious pneumonitis; fatal and/or serious infections, and fatal and serious intestinal perforation associated with Zydelig treatment by informing healthcare providers of the risks of

  1. fatal and/or serious hepatotoxicity
  2. fatal and/or serious and severe diarrhea or colitis
  3. fatal and/or serious pneumonitis
  4. fatal and/or serious infections
  5. fatal and serious intestinal perforation

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 Zydelig REMS, see the DailyMed link(s).
Material Name Material Name Link
Fact Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Fact_Sheet.pdf
Letter for Professional Societies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Letter_for_Professional_Societies.pdf
Letter to Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Letter_to_Healthcare_Providers.pdf
Patient Safety Information Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Patient_Safety_Information_Card.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_Full.pdf
REMS Website Screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zydelig_2017-01-04_REMS_Website_Screenshot.pdf

What updates have been made to the REMS?

Date Summary of change
01/04/2017 Modified to change the REMS materials based on the safety labeling changes approved on September 21, 2016, include the addition of a new risk (fatal and/or serious infections) to the REMS goal statement, and change the timetable for submission of REMS assessments.
07/23/2014 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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English