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:- 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;
- 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
- 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.
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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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:
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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.