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 the first prescription
  • Counsel the patient and/or patient guardian using the Medication Guide.
  • Enroll the patient by completing and submitting the Patient Registration Form.
Every three years
  • Re-enroll in the Zyprexa Relprevv REMS program by completing the Prescriber Enrollment Form.
At all times
  • Report a post-injection delirium sedation syndrome (PDSS) event to the REMS program using the Post-Injection Delirium/Sedation Form.

Patients who are prescribed Zyprexa Relprevv

Before the first prescription
  • Review the Medication Guide.
  • Enroll in the REMS by completing the Patient Registration Form with the prescriber.
  • Receive counseling from the prescriber on the risk and benefits of treatment using the Medication Guide.
After administration
  • Get observed in a clinic continuously for three hours.
At all times
  • 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 on behalf of the pharmacy.
  • Have the authorized representative review the Patient Care Program Instruction Brochure.
  • Train all relevant staff involved in the REMS program using Patient Care Program Instruction Brochure.
  • Have the authorized representative enroll in the REMS by completing the Pharmacy Registration Form or the Buy and Bill Registration Form.
Before dispensing
  • Obtain authorization to dispense by processing the prescription through the pharmacy management system.
Every three years
  • Re-enroll in the Zyprexa Relprevv REMS program by completing the Pharmacy Registration Form or Buy and Bill Registration Form.
At all times
  • Report the date of dispensing to the REMS program.

Healthcare settings that dispense Zyprexa Relprevv must

To become certified to dispense
  • 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.
  • Train all relevant staff involved in the REMS program using 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 dispensing
  • Provide the patient with a Medication Guide.
  • Obtain authorization to dispense by processing the prescription through the pharmacy management system.
After administering
  • Assess the patient’s condition by ensuring continuous monitoring for at least three hours. Assess the patient’s condition by ensuring continuous monitor for at least three hours.
Every three years
  • Re-enroll in the Zyprexa Relprevv REMS program by completing the Healthcare Facility Registration Form. Re-enroll in the Zyprexa Relprevv REMS program by completing the Healthcare Facility Registration Form.
At all times
  • Report the administration of Zyprexa Relprevv to the REMS program using the Single Patient Injection or Multiple Patient Injection 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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