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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.
Enroll in the REMS Program by completing the Prescriber Registration Form and submitting it to the REMS Program.
| Prescriber Registration Form |
Before treatment initiation (first dose)
Counsel the patient or patient guardian using the Medication Guide.
Enroll the patient in the REMS Program by completing the Patient Registration Form and submitting it to the REMS Program. Provide a completed copy of the form to the patient.
| Patient Registration Form |
To maintain certification to prescribe; every three years
Patients who are prescribed Zyprexa Relprevv or their guardians:
Before the first prescription
Review the Medication Guide
Enroll in the REMS Program by completing the Patient Registration Form with the prescriber. Enrollment information will be provided to the REMS Program.
| Patient Registration Form |
Receive counseling from the prescriber on the risks and benefits of treatment using the Medication Guide.
During treatment; after each administration
Be monitored continuously for three hours by healthcare staff.
Have someone with you when you leave the clinic after each injection
Do not drive or operate heavy machinery for the rest of the day after each injection.
At all times
Seek medical care right away and inform the prescriber if experiencing excessive sleepiness, dizziness, confusion, difficulty talking,
difficulty walking, muscle stiffness or shaking, weakness, irritability, aggression, anxiety, increase in blood pressure or convulsions.
Obtain authorization to dispense each prescription by contacting the REMS Program Call Center or using the REMS Program Website.
Verify the patient will be accompanied upon leaving the healthcare facility.
After administering
Verify the patient will be accompanied upon leaving the healthcare facility.
Verify that the patient was alert, oriented, and absent of any signs and symptoms of PDSS prior to being released form the healthcare facility.
Have the authorized representative re-enroll in the REMS Program by completing the Healthcare Facility Registration Form.
| Healthcare Facility Registration Form |
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 Zyprexa Relprevv REMS, see the DailyMed link(s).
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:
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.
Change the hours of operation for Patient Care Program Call Center.
Remove references/links on the Zyprexa Relprevv REMS website to Spanish Translations of the United States Prescribing In formation (USPI) and Medication Guide.
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.
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.
