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The goal of the Zyprexa Relprevv REMS is to mitigate the risk of serious adverse drug
experiences resulting from Post-Injection Delirium/Sedation Syndrome (PDSS).
Patients are monitored for at least three hours after administration of Zyprexa Relprevv
at a certified healthcare setting.
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.
Healthcare Providers who prescribe Zyprexa Relprevv must:
To become certified to
prescribe
Review the drug’s Prescribing Information.
Review the Healthcare Provider Training.
Successfully complete and submit the Prescriber
Knowledge Assessment to the REMS.
Enroll in the REMS by completing and submitting the
Prescriber Enrollment Form to the REMS.
Before treatment initiation
(first dose)
Counsel the patient on Post-Injection/Delirium
Sedation Syndrome (PDSS) using the Medication
Guide. Provide a copy of the material to the patient.
Enroll the patient in the REMS by completing and
submitting the Patient Enrollment Form to the REMS.
Provide a completed copy of the form to the patient.
To maintain certification to
prescribe; every 3 years
Review the drug’s Prescribing Information.
Review the Healthcare Provider Training.
Successfully complete and submit the Prescriber
Knowledge Assessment to the REMS.
Re-enroll in the REMS by completing and submitting
the Prescriber Enrollment Form to the REMS.
At all times, within 1 day
Report PDSS events to the REMS using the Post-
Injection Delirium/Sedation Form.
Patients who are prescribed Zyprexa Relprevv:
Before treatment initiation
Review the Medication Guide.
Receive counseling from the prescriber using the
Medication Guide.
Enroll in the REMS by completing the Patient
Enrollment Form with the prescriber. Enrollment
information will be provided to the REMS.
After administration, for at
least 3 hours
Be monitored for Post-Injection Delirium/Sedation
Syndrome (PDSS) continuously by healthcare staff in
a healthcare setting.
After administration
Have someone with you when you leave.
At all times
Get 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.
Pharmacies that dispense Zyprexa Relprevv must:
To become certified to
dispense
Designate an authorized representative to carry out
the certification process and oversee implementation
and compliance with the REMS on behalf of the
pharmacy.
Have the authorized representative review the
Pharmacy Guide
Have the authorized representative enroll in the REMS
by completing and submitting the Pharmacy
Enrollment Form to the REMS.
Have the authorized representative train all relevant
staff involved dispensing using the Pharmacy Guide.
Establish processes and procedures to report the date
of dispensing to the REMS.
Establish processes and procedures to verify that
Zyprexa Relprevv is dispensed directly to a certified
healthcare setting and the drug is not dispensed
directly to the patient.
Before dispensing
Obtain authorization to dispense each prescription by
contacting the REMS to verify the prescriber is
certified, patient is enrolled, and the healthcare
setting is certified.
Report the date of dispensing to the REMS through
the processes and procedures established as a
requirement of the REMS.
To maintain certification to
dispense; every 3 years
Have the authorized representative review the
Pharmacy Guide.
Have the authorized representative re-enroll in the
REMS by completing and submitting the Pharmacy
Enrollment Form to the REMS.
To maintain certification to
dispense
If the authorized representative changes, have a new
authorized representative review the Pharmacy Guide.
Have a new authorized representative re-enroll in the
REMS by completing and submitting the Pharmacy
Enrollment Form to the REMS.
At all times
Not distribute, transfer, loan, or sell Zyprexa
Relprevv.
Not dispense Zyprexa Relprevv for use outside a
certified healthcare setting.
Not dispense Zyprexa Relprevv directly to patients.
Maintain records documenting staff’s completion of
training.
Maintain records that all REMS processes and
procedures are in place and are being followed.
Comply with audits by CHEPLAPHARM Registration
GmbH or a third party acting on behalf of
CHEPLAPHARM Registration GmbH to ensure that all
processes and procedures are in place and are being
followed.
Healthcare settings that dispense Zyprexa Relprevv for administration must:
To become certified to
dispense for administration
Have ready access to emergency response services.
Be able to monitor patients continuously for at least 3
hours post-injection and provide close medical
supervision if Post-Injection Delirium/Sedation
Syndrome (PDSS) is suspected.
Designate an authorized representative to carry out
the certification process and oversee implementation
and compliance with the REMS on behalf of the
healthcare setting.
Have the authorized representative review the
Healthcare Provider Training.
Have the authorized representative successfully
complete and submit the Healthcare Setting
Knowledge Assessment to the REMS.
Have the authorized representative enroll in the REMS
by completing and submitting the Healthcare Setting
Enrollment Form to the REMS.
Have the authorized representative train all relevant
staff involved in administering using the Healthcare
Provider Training.
Establish processes and procedures to monitor
patients continuously for at least 3 hours after
administration and provide close medical supervision if
PDSS is suspected.
Establish processes and procedures to provide the
patient with the Medication Guide before
administration, verify the prescriber is certified and
the patient is enrolled before administration, and that
the patient is accompanied upon leaving the
healthcare setting to their destination.
Before administering
Provide the patient with the Medication Guide.
Document using the Patient Injection Form.
Verify that the patient is enrolled, and the prescriber
is certified in the REMS. Document using the Patient
Injection Form.
Verify the patient will be accompanied upon leaving
the healthcare setting.
After administering, for at
least 3 hours post-injection
Assess the patient’s health status continuously for
sign and symptoms of PDSS. Document using the
Patient Injection Form.
Assess the patient for resolution of any signs or
symptoms of PDSS.
After administering, before
discharge
Verify that the patient is alert, oriented, and absent of
any signs and symptoms of PDSS. Document using
the Patient Injection Form.
Verify that the patient will be accompanied upon
leaving the healthcare setting. Document using the
Patient Injection Form.
After administering, within 3
days
Submit the Patient Injection Form to the REMS.
To maintain certification to
dispense; every 3 years
Have the authorized representative review the
Healthcare Provider Training.
Have the authorized representative successfully
complete and submit the Healthcare Setting
Knowledge Assessment to the REMS.
Have the authorized representative re-enroll in the
REMS by completing and submitting the Healthcare
Setting Enrollment Form to the REMS.
To maintain certification to
dispense
If the authorized representative changes, have a new
authorized representative review the Healthcare
Provider Training.
Have a new authorized representative successfully
complete and submit the Healthcare Setting
Knowledge Assessment to the REMS.
Have a new authorized representative re-enroll in the
REMS by completing and submitting the Healthcare
Setting Enrollment Form to the REMS.
At all times
Report PDSS events to the prescriber.
Not dispense Zyprexa Relprevv for use outside a
certified healthcare setting.
Not distribute, transfer, loan, or sell Zyprexa
Relprevv.
Maintain records documenting staff’s completion of
training.
Maintain records that all REMS processes and
procedures are in place and are being followed.
Comply with audits by CHEPLAPHARM Registration
GmbH or a third party acting on behalf of
CHEPLAPHARM Registration GmbH to ensure that all
processes and procedures are in place and are being
followed.
Wholesalers-distributors that distribute Zyprexa Relprevv must:
To be able to distribute
Establish processes and procedures to ensure that the
drug is distributed only to certified pharmacies.
Train all relevant staff involved in distributing on the
REMS requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of all drug distribution.
Comply with audits carried out by CHEPLAPHARM
Registration GmbH or a third party acting on behalf of
CHEPLAPHARM Registration GmbH to ensure that all
processes and procedures are in place and are being
followed.
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).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters,
and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
05/07/2026
Modified to include the following:
Updates to remove any mention of "single-use" language in REMS materials.
Changes to REMS program name to Zyprexa Relprevv REMS.
Updates to REMS goal and objectives to focus on the safe use behaviors for
mitigating the risk of post-injection delirium/sedation syndrome (PDSS).
Updates to REMS Document with changes that are consistent with the Guidance
Document, Format and Content of a REMS Document (January 2023) and the
REMS Document Technical Conformance Guide (January 2023).
Addition of knowledge assessments for prescribers and healthcare settings for
initial certification and recertification.
Addition of requirement for pharmacies to obtain authorization to dispense from
the REMS before each dispense.
Changes to the audit requirements for pharmacies and healthcare settings, and
addition of audit requirements for wholesalers-distributors to the REMS
Document.
Streamlined REMS materials to improve messaging of risk and REMS
requirements.
Updates to the REMS website, including changes to layout and addition of the
certified pharmacy finder and the certified healthcare setting finder.
Updates to the Communication Plan to disseminate the Healthcare Professional
Letter and Fact Sheet to prescribers, pharmacies, and healthcare settings.
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.
