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Approved Risk Evaluation and Mitigation Strategies (REMS)

Zyprexa Relprevv (olanzapine)
NDA #022173
REMS last update: 04/28/2021



What is the purpose of the REMS?

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:
  1. ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
  2. informing healthcare providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified health care facilities; and
  3. establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program Registry.

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.

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

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
04/28/2021 Modified to make updates to the Privacy Policy page of the Zyprexa Relprevv (olanzapine pamoate) Patient Care Program (PCP) Website to meet current requirements, including updating and hyperlinking of the California Privacy Policy Statement.
04/22/2020 Modified the Zyprexa Relprevv Patient Care Program Instructions Brochure to align with recent approved changes to the U.S. Prescribing Information (USPI) and the Medication Guide (MG).
04/11/2019 Modified to remove Important Safety Information references within the Patient Care Program Website and to update the Prescribing Information in the Patient Care Program Instructions Brochure.
11/30/2017 Modified to update various appended REMS materials.
10/30/2014 Modified to:

  1. Include updates to name and patent, latex-free statements, graphics, address combinations, the removal of the term “non-pyrogenic”, and the addition of a cautionary statement on single use medical devices in the Instructions to Reconstitute and Administer Zyprex a Relprevv Poster.
  2. Change the hours of operation for Patient Care Program Call Center.
  3. Remove references/links on the Zyprexa Relprevv REMS website to Spanish Translations of the United States Prescribing In formation (USPI) and Medication Guide.
  4. Reinforce the requirement that dispensers report the date Zyprexa Relprevv is dispensed prior to the Convenience Kit leaving the premises in the Zyprexa Relprevv Patient Care Program Instructions Brochure, Pharmacy Registration Form, and Buy & Bill Pharmacy Service Provider Registration Form.
  5. Provide consistency in terminology throughout the REMS and REMS appended materials by changing the term “vial kit” to “Convenience Kit” in the Zyprexa Relprevv Patient Care Program Instructions Brochure, Pharmacy Registration Form and Buy & Bill Pharmacy Service Provider Registration Form.
03/27/2013 Modified to update the REMS Patient Care Program website.
08/03/2012 Modified to add most current updated version and replace the prior REMS issued.
07/08/2010 Modified to align cutoff dates for REMS assessments and new drug application (NDA) and investigational new drug (IND) annual reports.
12/11/2009 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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