Approved Risk Evaluation and Mitigation Strategies (REMS)

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Blincyto (blinatumomab)
BLA #125557
REMS last update: 05/16/2019



What is the purpose of the REMS?

The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe, life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:

  1. Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
  2. Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
  3. Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated with use of BLINCYTO

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 Blincyto REMS, see the DailyMed link(s).
Material Name Material Name Link
Fact Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 Fact Sheet.pdf
Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 Letter for Healthcare Providers.pdf
Letter for Hospital and Homecare Pharmacists (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 Letter for Hospital and Homecare Pharmacists.pdf
Letter for Professional Societies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 Letter for Professional Societies.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 REMS Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 REMS Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blincyto 2019 05 16 REMS Website Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
05/16/2019 Revised to make an editorial change.
04/18/2019 Modified to add instructions in the REMS letters and Fact Sheet to administer corticosteroids for severe or lifethreatening CRS.
02/05/2019 Revised to make editorial changes.
04/10/2018 Modified to align with the Prescribing Information revised on March 29, 2018.
03/29/2018 Modified to include safety data and a new indication to the REMS materials.
07/12/2017 Modified to incorporate the proposed changes to the Prescribing Information and make other minor edits to the REMS materials.
01/30/2017 Revised to make an editorial change(s).
08/30/2016 Modified to include the distribution of the REMS Letter for Professional Societies to pediatric-related professional societies and organizations in the communication plan.
12/03/2014 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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