Approved Risk Evaluation and Mitigation Strategies (REMS)

Contact Us | REMS Basics | Gov Delivery Get REMS Email Alerts | Reports & Data Files

Zyprexa Relprevv (olanzapine)
NDA #022173
REMS last update: 10/30/2014



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

Healthcare Providers who prescribe Zyprexa Relprevv must

To become certified to prescribe
Before treatment initiation (first dose)
  • Counsel the patient or patient guardian using the Medication Guide.
  • Enroll the patient by completing and submitting the Patient Registration Form 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
At all times
  • Report post-injection delirium sedation syndrome (PDSS) events to the REMS program using the Post-Injection Delirium/Sedation Form. Report post-injection delirium sedation syndrome (PDSS) events to the REMS program using the Post-Injection Delirium/Sedation Form.
    | Multiple Patient Injection Form | | Single Patient Injection Form |

Patients who are prescribed Zyprexa Relprevv or their guardians

Before the first prescription
  • Review the Medication Guide.
  • Enroll in the REMS 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 risk 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
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

Healthcare settings that dispense Zyprexa Relprevv must

To become certified to dispense
Before administering
  • Provide the patient with a 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
  • Assess the patient’s condition by ensuring continuous monitoring for at least three hours. Document and submit the result to the REMS program using the Single or Multiple Patient Injection Form.
    | Multiple Patient Injection Form | | Single Patient Injection Form |
  • Verify that the patient was alert, oriented, and absent of any signs and symptoms of PDSS prior to being released form the health-care facility.
To maintain certification to dispense; every three years
  • Have the authorized representative re-enroll in the REMS program by completing the Healthcare Facility Registration Form. 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_2014-10-30_BUY AND BILL PHARMACY SERVICE PROVIDER REGISTRATION FORM .pdf
Healthcare Facility Registration Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_HEALTHCARE FACILITY REGISTRATION FORM .pdf
Healthcare Professional Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30 _HEALTHCARE PROFESSIONAL TRAINING .pdf
Multiple Patient Injection Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_MULTIPLE PATIENT INJECTION FORM .pdf
Patient Care Program Instructions Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_PATIENT CARE PROGRAM INSTRUCTIONS BROCHURE .pdf
Patient Registration Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30 _PATIENT REGISTRATION FORM .pdf
Pharmacy Registration Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_PHARMACY REGISTRATION FORM .pdf
Post Injection Delirium Sedation Syndrome (PDSS) Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_POST INJECTION DELIRIUM SEDATION SYNDROME (PDSS) FORM .pdf
Prescriber Registration Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_PRESCRIBER REGISTRATION FORM.pdf
Reconstitution and Administration Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_RECONSTITUTION AND ADMINISTRATION TRAINING.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_REMS DOCUMENT .pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_FULL.pdf
REMS Website Screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_REMS WEBSITE .pdf
Single Patient Injection Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zyprexa Relprevv_2014-10-30_SINGLE PATIENT INJECTION FORM .pdf

What updates have been made to the REMS?

Date Summary of change
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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English