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The goal of the Sodium Oxybate REMS Program is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of sodium oxybate by:
A. Informing prescribers, pharmacists, and patients of:
The risk of significant CNS and respiratory depression associated with sodium oxybate
The contraindication of use of sodium oxybate with sedative hypnotics and alcohol
The potential for abuse, misuse, and overdose associated with sodium oxybate
The safe use, handling, and storage of sodium oxybate
B. Ensuring that pharmacy controls exist prior to filling prescription for sodium oxybate that:
Screen for concomitant use of sedative hypnotics and other potentially interacting agents
Monitor for inappropriate prescribing, misuse, abuse, and diversion of sodium oxybate
Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion
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).
Healthcare Providers who prescribe a sodium oxybate product must
Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the Sodium Oxybate REMS Program.
| Prescriber Enrollment Form |
Before treatment initiation
Determine that sodium oxybate is medically appropriate for the patient.
Assess the patient for a 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; and history of depression or suicidality.
Counsel the patient on the serious risks and safe use, handling, and storage.
Enroll the patient by completing and submitting the Patient Enrollment Form to the Sodium Oxybate REMS Program.
| Patient Enrollment Form |
During treatment; before each prescription
Complete the Prescription Form and submit to a specially certified pharmacy.
| Prescription Form |
During treatment; within the first 3 months and recommended every 3 months thereafter
Assess the patient for concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents; serious adverse events; and signs of abuse and misuse, including an increase in dose or frequency of dosing, reports of lost, stolen, or spilled medication, and drug-seeking behavior.
At all times
Report all potential serious adverse events, including CNS depression, respiratory depression, loss of consciousness, coma, death, and any cases of abuse, misuse, or diversion to the Sodium Oxybate REMS Program.
Patients who are prescribed a sodium oxybate product
Before the first prescription
Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the Sodium Oxybate REMS Program.
| Patient Enrollment Form |
Receive counseling from the prescriber on serious risks, and safe use, handling, and storage.
Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
Have the authorized representative enroll the pharmacy in the Sodium Oxybate REMS Program by completing the Pharmacy Enrollment Form.
| Pharmacy Enrollment Form |
Before dispensing
Complete the Patient Counseling Checklist and submit to the Sodium Oxybate REMS Program.
| Patient Counseling Checklist |
Verify the prescriber and patient are enrolled and that the patient has no other active sodium oxybate prescription by obtaining a Pre-Dispense Authorization (PDA) from the Sodium Oxybate REMS Program.
Verify all prescription information on the Prescription Form.
Review the patient information using the Sodium Oxybate REMS Program website and the Prescription Form.
Verify relevant patient information by calling the Xyrem REMS Program. Document that the call to the Xyrem REMS Program was completed using the Prescription Form.
| Prescription Form |
Before shipping
Verify and confirm the patient’s shipping address with the patient or their patient-authorized adult representative and that they will be available to receive the shipment.
Ship the product directly to the patient or their patient-authorized adult designee using an overnight service.
Provide the patient with the Medication Guide with each shipment.
For the first shipment: provide the patient with the Patient Quick Start Guide.
| Patient Quick Start Guide |
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.
After receipt of the shipment
Submit the shipment and receipt dates to the Sodium Oxybate REMS Program.
To maintain certification to dispense, if the pharmacy designates a new authorized representative
Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
Have the authorized representative enroll the pharmacy in the REMS Program by completing the Pharmacy Enrollment Form.
| Pharmacy Enrollment Form |
At all times
Report all potential adverse events reported by all sources, including any CNS depression, respiratory depression, loss of consciousness, coma, and death and any cases of suspected abuse, misuse, or diversion to the Sodium Oxybate REMS program.
Report all instances of patient or prescriber behavior that gives rise to a reasonable suspicion of abuse, misuse, or diversion to the Sodium Oxybate REMS Program.
For early refills including lost, stolen, destroyed, or spilled drugs: complete and submit the Risk Management Form to the Sodium Oxybate REMS Program.
| Risk Management Report Form |
Provide 24-7 toll-free access to a pharmacist from the REMS Program.
Wholesalers that distribute a sodium oxybate product must
To be able to distribute
Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies on a per patient basis.
The REMS includes a REMS Document.
In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Sodium Oxybate REMS, see the DailyMed link on the Products tab.
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
01/17/2017
Approval of the REMS.
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.
