Approved Risk Evaluation and Mitigation Strategies (REMS)

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Xyrem (Sodium oxybate)
NDA #021196
REMS last update: 07/15/2015

View the Xyrem Prescribing Information and Medication Guide at DailyMed.
View Xyrem'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 Xyrem

To be able to prescribe Xyrem
  • Review the prescribing information for Xyrem.
  • Review the educational materials for prescribers, including: the Prescriber Brochure.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
Before writing the first prescription for a patient
  • Be able to determine that Xyrem is medically appropriate for the patient.
  • Counsel the patient regarding the serious risks and safe use, handling, and storage of the medication.
  • Assess the patient for a history of alcohol or substance abuse; history of sleep-related disorders; history of compromised respiratory function; concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents; and a history of depression or suicidality.
  • Enroll the patient by completing and submitting the Patient Enrollment Form.
  • Complete and submit the Prescription Form.
  • List all known prescription and nonprescription medications and doses on the Prescription Form.
Before writing each prescription after the first prescription
  • Complete and submit the Prescription Form.
While patient is being treated with Xyrem
  • Within the first three months and recommended every three months thereafter: assess the patient for the concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents; serious adverse events; signs of abuse and misuse.
Ongoing
  • Report serious adverse events, including CNS depression, respiratory depression, loss of consciousness, coma, death, and any case of suspected abuse, misuse, or diversion to the sponsor.

Patients who receive Xyrem

To be able to receive Xyrem
  • Enroll in the REMS by completing the Patient Enrollment Form with the prescriber.

Pharmacies that dispense Xyrem

To be able to dispense Xyrem
  • Train all relevant staff involved in the dispensing of Xyrem using the Pharmacy Training Program.
Before dispensing Xyrem
  • Complete and submit the Patient Counseling Checklist.
  • Verify the prescriber and patient are enrolled and that the patient has no other active Xyrem prescription using the REMS Program Central Database.
  • Verify all prescription information.
  • Review the patient information using the REMS Program Central Database.
When shipping Xyrem
  • Verify and confirm the patient’s shipping address and that the patient or patient-authorized adult designee will be available to receive the shipment.
  • Ship the medication directly to the patient, or a patient-authorized adult designee, using an overnight service.
  • Provide a Medication Guide with each shipment.
  • For each new patient: provide a copy of the Patient Quick Start Guide if they have not already received it from the prescriber.
  • Verify the receipt of the shipment.
  • For the first shipment: dispense no more than a one-month supply.
  • For shipments after the first: dispense no more than a three-month supply.
Ongoing
  • Provide 24-7 toll-free access to the REMS Program pharmacist.
  • Report serious adverse events, including CNS depression, respiratory depression, loss of consciousness, coma, death, and any case of suspected abuse, misuse, or diversion to the sponsor.
  • Maintain records of patient or prescriber behavior that raises suspicions of abuse, misuse, or diversion in the REMS Program Central Database using the Risk Management Report Form.
  • Maintain records of each shipping and receipt of shipment.

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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