LOS ANGELES COUNTY
DEPARTMENT OF MENTAL HEALTH
  Policy 351.04 Olanzapine Pamoate (ZYPREXA RELAPREVV™) Long-Acting Injection for Schizophrenia (306.29)
 
  PROCEDURES
  1. Patient Criteria:
    1. Inclusion Criteria: Client must fulfill all inclusion criteria (exceptions may be made for clients who meet partial criteria on a case-by-case review)
      1. All Risk Evaluation and Mitigation Strategies (REMS) requirements have been met DMH Policy 351.05.
      2. Client is 18 years old with a diagnosis of schizophrenia or schizoaffective disorder.
      3. Client has been started and stabilized on ZYPREXA RELPREVV by an outside provider and is now being seen at a directly operated (DO) clinic.
      4. Client agrees to stay and be monitored for at least three (3) hours after administration.
      5. Client or caregiver confirms client has a designated driver post-injection (cannot be a taxi or ride-sharing company).
      6. Client or caregiver provides a signed informed consent form.
      7. For women of child-bearing age, client must be provided contraceptive counseling and educated on the potential risks versus benefits of receiving ZYPREXA RELPREVV if the client were to become pregnant.
    2. Exclusion Criteria: If client meets any of the exclusion criteria, they shall NOT receive ZYPREXA RELPREVV
      1. Hypersensitivity to olanzapine or any of the excipients.
      2. History of non-response to olanzapine (not including failure due to poor adherence).
  2. Administration and Monitoring
    1. Prior to each administration, the following must be completed and verified:
      1. Client is enrolled in the ZYPREXA RELPREVV Patient Care Program and has an active medication order in OrderConnect.
      2. Client has a designated driver (not taxi, Uber, Lyft, etc.).
      3. Client or caregiver is provided a ZYPREXA RELPREVV Patient Care Program Medication Guide
    2. Follow the ZYPREXA RELPREVV Patient Care Program Medication Guide for proper reconstitution and administration technique.
    3. Client must be monitored for at least three (3) hours after injection for post-injection delirium/sedation syndrome (PDSS).
    4. Prior to discharge, client shall be evaluated by a psychiatrist and determined to be alert, oriented, and without any signs/symptoms of PDSS.
    5. Injection data must be submitted individually for each patient by using the Single Patient Injection Form found in the ZYPREXA RELPREVV Patient Care Program Instructions Brochure.
      1. Forms shall be scanned and uploaded to client’s record after each injection.
  3. Identifying and Responding to Potential PDSS
    1. What is PDSS?
      1. Related to excessive olanzapine plasma concentration
    2. Incidence
      1. In pre-marketing ZYPREXA RELPREVV clinical trials:
        1. PDSS events occurred in 0.07% of injections (~1 event per 1400 injections)
        2. Approximately 1.7% of clients experienced PDSS
    3. Typical Presentation:
      1. Sedation: ranging from mild in severity to coma (lasting up to 12 hours).
      2. Delirium: confusion, disorientation, agitation, anxiety, and other cognitive impairments.
      3. Other symptoms noted include: extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension, or convulsions.
      4. There are no recommendations from ZYPREXA RELPREVV on specific monitoring tools or scales that should be used to observe clients.
        1. Optional tools that can be used for objective measurement of sedation/delirium include:
          • Richmond Agitation-Sedation Scale (RASS)
          • Confusion Assessment Method (CAM) scale
    4. Typical onset of action for those who experience PDSS:
      1. Milder symptoms will appear first and progress in severity or number.
      2. Usual time of onset:
        Time of Onset of Symptoms % of patients
        < 1 hour ~ 80%
        > 1 hour - 3 hours ~ 14%
        > 3 hours ~ 6%
    5. Response:
      1. If a client is suspected of experiencing PDSS, continue to monitor the client and call 911.
      2. Report all suspected cases of PDSS to ZYPREXA RELPREVV Patient Care Program within 24 hours of the event (please see below in REMS reporting requirement for more information).
  4. REMS Reporting Requirements
    1. Single Patient Injection Form shall be submitted within seven (7) days of injection administration for each injection. The forms shall be submitted in one of the following ways:
      • Telephone: 1-877-772-9390
      • Fax: 1-877-772-9391
      • Internet: www.zyprexarelprevvprogram.com
    2. All suspected cases of PDSS shall be reported to ZYPREXA RELPREVV Patient Care Program within 24 hours of awareness of the event. For each suspected PDSS event, the prescriber shall record and submit data to the ZYPREXA RELPREVV Patient Care Program in one of the following ways:
      • Telephone: 1-877-772-9391
      • Fax: 1-877-772-9391
      • Internet: www.zyprexarelprevvprogram.com