Risk Evaluation and Mitigation Strategy (REMS)

Prescriber Roles & Responsibilities

To become certified, each prescriber must complete a one-time enrollment by completing the XYREM REMS Program Prescriber Enrollment Form and submitting it to the XYREM REMS Program via facsimile, email, or mail.

Prescribers enrolled in the XYREM REMS Program agree to:

  1. Review the Prescribing Information (PI) and the XYREM REMS Program Prescriber Brochure.
  2. Screen each patient for:
    • History of alcohol or substance abuse
    • History of sleep-related breathing disorders
    • History of compromised respiratory function
    • Concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents
    • History of depression or suicidality
  3. Counsel each patient prior to initiating therapy with XYREM on the serious risks and safe use and handling of XYREM using the XYREM REMS Program Quick Start Guide.
  4. Enroll each patient in the XYREM REMS Program by completing the XYREM REMS Program Patient Enrollment Form and submitting the form to the XYREM REMS Program.
  5. Evaluate each patient within the first 3 months of starting XYREM therapy, including an evaluation of the following. It is recommended that patients be re-evaluated every 3 months thereafter while taking XYREM.
    1. Concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents
    2. Serious adverse events
    3. Signs of abuse and misuse, including:
      1. an increase in dose or frequency of dosing
      2. reports of lost, stolen, or spilled medication
      3. drug-seeking behavior
  6. Report all potential serious adverse events, including CNS depression, respiratory depression, loss of consciousness, coma, death, and any cases of suspected abuse, misuse, or diversion to Jazz Pharmaceuticals.

Each time a new prescription is written the prescriber will complete the XYREM REMS Program Prescription Form and submit it to the XYREM REMS Program. By completing and signing this form, the prescriber acknowledges:

  1. Having an understanding of:
    1. The approved indications for XYREM:
      1. Treatment of cataplexy in narcolepsy
      2. Treatment of excessive daytime sleepiness in narcolepsy
    2. The serious risks associated with XYREM
    3. The Prescribing Information and XYREM REMS Program Prescriber Brochure
  2. Having screened the patient for the following:
    1. History of alcohol or substance abuse
    2. History of sleep-related breathing disorders
    3. History of compromised respiratory function
    4. Concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents
    5. History of depression or suicidality
  3. Having counseled the patient on:
    1. The serious risks associated with XYREM
    2. Contraindications (alcohol and sedative hypnotics) and implications of concomitant use of XYREM with other potentially interacting agents
    3. Preparation and dosing instructions for XYREM
    4. Risk of abuse and misuse associated with XYREM
    5. Risk of operating hazardous machinery including automobiles or airplanes for the first 6 hours after taking a dose of XYREM
    6. Safe use, handling, and storage of XYREM
  4. That XYREM is medically appropriate for the patient
  5. Having listed all known prescription and nonprescription medications and doses on the XYREM REMS Program Prescription Form