Approved Risk Evaluation and Mitigation Strategies (REMS)

Zyprexa Relprevv (olanzapine)

NDA #022173

REMS last update: 04/28/2021

• View the Zyprexa Relprevv Prescribing Information and Medication Guide at DailyMed.
• View Zyprexa Relprevv's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

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

Healthcare providers who prescribe Zyprexa Relprevv must:

To become certified to prescribe	Review the Healthcare Professional Training. | Healthcare Professional Training | 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	Re-enroll in the REMS Program by completing the Prescriber Registration Form. | Prescriber Registration Form |
At all times	Report post-injection delirium sedation syndrome (PDSS) events to the REMS Program using the Post-Injection Delirium/Sedation Form. | Post-Injection Delirium/Sedation Syndrome Form |

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.

Pharmacies that dispense Zyprexa Relprevv must:

To become certified to dispense	Train all relevant staff involved in the REMS Program using the Patient Care Program Instruction Brochure. | Patient Care Program Instructions Brochure | Designate an authorized representative to carry out the certification process on behalf of the pharmacy or healthcare setting. Have the authorized representative review the Patient Care Program Instruction Brochure.
Before dispensing	Not dispense Zyprexa Relprevv directly to patients. Obtain authorization to dispense each prescription by contacting the REMS Program Call Center or using the REMS Program Website.
After dispensing	Report the date of dispensing to the REMS Program
To maintain certification to dispense; every three years	Have the authorized representative re-enroll in the REMS Program by completing the Pharmacy Registration Form or Buy & Bill Pharmacy Service Provider Registration Form. | Pharmacy Registration Form | | Buy and Bill Pharmacy Service Provider Registration Form |

Healthcare settings that dispense Zyprexa Relprevv must:

To become certified to dispense	Train all relevant staff involved in the REMS Program using the Patient Care Program Instruction Brochure, Healthcare Professional Training, and Reconstitution and Administration Training. | Reconstitution and Administration Training Video | | Healthcare Professional Training | | Patient Care Program Instructions Brochure | Designate an authorized representative to carry out the certification process on behalf of the healthcare setting. Have the authorized representative review the Patient Care Program Instruction Brochure. | Patient Care Program Instructions Brochure |
Before administering	Provide the patient with the Medication Guide. 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).

Material Name	Material Name Link
Buy and Bill Pharmacy Service Provider Registration Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Buy_and_Bill_Pharmacy_Service_Provider_Registration_Form.pdf
Healthcare Facility Registration Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Healthcare_Facility_Registration_Form.pdf
Healthcare Professional Training (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Healthcare_Professional_Training.pdf
Multiple Patient Injection Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Multiple_Patient_Injection_Form.pdf
Patient Care Program Instructions Brochure (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Patient_Care_Program_Instructions_Brochure.pdf
Patient Registration Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Patient_Registration_Form.pdf
Pharmacy Registration Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Pharmacy_Registration_Form.pdf
Post-Injection Delirium/Sedation Syndrome Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Post_Injection_Delirium_Sedation_Syndrome_Form.pdf
Prescriber Registration Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Prescriber_Registration_Form.pdf
Reconstitution and Administration Training Video (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Reconstitution_and_Administration-Training_Video.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_REMS_Full.pdf
REMS Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_REMS_Website_Screenshots.pdf
Single Patient Injection Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa_Relprevv_2021_04_28_Single_Patient_Injection_Form.pdf

Assessment Plan

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
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.