Approved Risk Evaluation and Mitigation Strategies (REMS)

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

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

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
  • Review the Healthcare Professional Training.
  • Enroll in the REMS by completing the Prescriber Registration Form and submitting it to the REMS program.
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.
To maintain certification to prescribe; every three years
  • Re-enroll in the REMS program by completing the 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. Report post-injection delirium sedation syndrome (PDSS) events to the REMS program using the Post-Injection Delirium/Sedation 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.
  • 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
  • Train all relevant staff involved in the REMS program using Patient Care Program Instruction 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.
  • Have the authorized representative enroll in the REMS by completing the Pharmacy Registration Form or the Buy and Bill Pharmacy Service Provider Registration Form.
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 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 Patient Care Program Instruction Brochure, Healthcare Professional Training, and Reconstitution and Administration Training.
  • 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.
  • Establish processes and procedures to verify a patient is continuously monitored for at least 3 hours post-injection for suspected post-injection delirium sedation syndrome (PDSS).
  • Have the authorized representative enroll in the REMS by completing the Healthcare Facility Registration Form.
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.
  • 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.

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:


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.

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