Approved Risk Evaluation and Mitigation Strategies (REMS)

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Sodium Oxybate
Shared System REMS
REMS last update: 01/17/2017

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
sodium oxybate ( Info at Drugs@FDA ) ANDA 202090 WEST-WARD PHARMS INT 01/17/2017 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202090

What is the purpose of the REMS?

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:

  1. The risk of significant CNS and respiratory depression associated with sodium oxybate
  2. The contraindication of use of sodium oxybate with sedative hypnotics and alcohol
  3. The potential for abuse, misuse, and overdose associated with sodium oxybate
  4. The safe use, handling, and storage of sodium oxybate
B. Ensuring that pharmacy controls exist prior to filling prescription for sodium oxybate that:
  1. Screen for concomitant use of sedative hypnotics and other potentially interacting agents
  2. Monitor for inappropriate prescribing, misuse, abuse, and diversion of sodium oxybate
  3. 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

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Review the Prescriber Brochure. | Prescriber Brochure |
  • 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.
  • Review the Patient Quick Start Guide. | Patient Quick Start Guide |

Pharmacies that dispense a sodium oxybate product must

To become certified to dispense
  • Train all relevant staff involved in dispensing using the Certified Pharmacy Training Program. | Certified Pharmacy Training Program |
  • 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.

View additional drug-specific postmarket safety information from the FDA

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. For a specific Medication Guide of a product in the Sodium Oxybate REMS, see the DailyMed link on the Products tab.

Material Name Material Name Link
Certified Pharmacy Training Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Certified_Pharmacy_Training_Program.pdf
Patient Counseling Checklist (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Patient_Counseling_Checklist.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Patient_Enrollment_Form.pdf
Patient Quick Start Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Patient_Quick_Start_Guide.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Pharmacy_Enrollment_Form.pdf
Prescriber Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Prescriber_Brochure.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Prescriber_Enrollment_Form.pdf
Prescription Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Prescription_Form.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium Oxybate_2017-01-17_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_REMS_Website_Screenshots.pdf
Risk Management Report Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sodium_Oxybate_2017-01-17_Risk_Management_Report.pdf

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.

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