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The goal of the XYWAV and XYREM REMS is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and
diversion of XYWAV and XYREM by:
Informing prescribers, pharmacists, and patients of:
The risk of significant CNS and respiratory depression associated with XYWAV and XYREM.
The contraindication of use of XYWAV and XYREM with sedative hypnotics and alcohol.
The potential for abuse, misuse, and overdose associated with XYWAV and XYREM.
The safe use, handling, and storage of XYWAV and XYREM.
Ensuring that pharmacy controls exist prior to filling prescriptions for XYWAV and XYREM that:
Screen for concomitant use of sedative hypnotics and other potentially interacting agents.
Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM.
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). See the application holder(s) REMS Website or the approved REMS materials for more information.
Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
| Prescriber Enrollment Form |
Before treatment initiation (first dose)
Assess the patient's health status to determine if XYWAV and XYREM is medically appropriate by screening for history or alcohol or substance abuse, sleep-related breathing disorders, compromised respiratory function, and depression or suicidality.
Assess the patient’s health status to determine if XYWAV or XYREM is medically appropriate by screening for concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents. Document and submit to the REMS Program using the product-specific Prescription Form.
| XYWAV Prescription Form |
| XYREM Prescription Form |
For patients dis-enrolled for suspicion of abuse, misuse, or diversion: communicate with the pharmacy and agree it is appropriate to re-enroll the patient.
For patients with a lapse in treatment for 6 months or longer: order the prescription using either the XYWAV Prescription Form or XYREM Prescription Form and submit it to the REMS Program.
| XYWAV Prescription Form |
| XYREM Prescription Form |
During treatment; within the first 3 months of starting treatment and recommended every 3 months thereafter
Assess the patient for: concomitant use of sedative hypnotics, other CNS depressants, or 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, and death, and any cases of suspected abuse, misuse, or diversion to Jazz Pharmaceuticals.
Receive counseling from the prescriber on the serious risks associated with XYWAV and XYREM and safe use, handling, and storage of XYWAV and XYREM using the XYWAV Patient Quick Start Guide, XYREM Patient Quick Start Guide, XYWAV Brochure for Pediatric Patients and their Caregivers, or XYREM Brochure for Pediatric Patients and their Caregivers.
Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program.
| Patient Enrollment Form |
Adhere to the safe use conditions described in the XYWAV Patient Quick Start Guide, XYREM Patient Quick Start Guide, XYWAV Brochure for Pediatric Patients and their Caregivers, or XYREM Brochure for Pediatric Patients and their Caregivers.
Complete the Patient Counseling Checklist with the pharmacist based on changes in your medication and/or medical history.
During treatment; within the first 3 months of starting treatment and recommended every 3 months thereafter
Be monitored for concomitant use of sedative hypnotics, other CNS depressants, or potentially interacting agents; serious adverse events; 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.
Before treatment re-initiation, after lapse in treatment for 6 months or longer
Complete the Patient Counseling Checklist with the pharmacist.
At all times
Inform your prescriber and the pharmacy about any new medications you may be taking or medical conditions you may have.
For all relevant staff involved in dispensing: successfully complete the Module A Knowledge Assessment and submit it to the REMS Program.
| Module A Knowledge Assessment |
For all pharmacists involved in dispensing: successfully complete the Module A Knowledge Assessment and Module B Knowledge Assessment and submit it to the REMS Program.
| Module B Knowledge Assessment |
| Module A Knowledge Assessment |
Train all pharmacists involved in dispensing per the requirements of the Pharmacy Training Program - Module B.
| Certified Pharmacy Training Program |
Establish processes and procedures to verify the following: the patient and prescriber are enrolled, the patient has no other active XYWAV or XYREM prescriptions.
Establish processes and procedures to verify all the prescription information including patient name and two additional identifiers,
prescriber name and information, dose, titration information (if applicable), number of refills, dosing directions, total quantity (days’ supply), and concomitant medications.
Establish processes and procedures to assess the patient’s concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents that either are unknown to the prescriber or pose a high risk of serious interaction.
Establish processes and procedures to provide 24-7 toll-free access to a XYWAV and XYREM REMS Program pharmacist; to dispense no more than a one-month supply for the initial shipment and no more than a three-month supply for subsequent shipments; and to ship, track, and verify receipt of XYWAV and XYREM to the patient or patient-authorized adult designee using an overnight service.
Before dispensing
For new patients and existing patients who restart treatment after not receiving XYWAV or XYREM for 6 months or longer: Counsel the patient using the Patient Counseling Checklist. Document and submit to the REMS Program using the Central Database.
| Patient Counseling Checklist |
For patients who report a change in their medication use or medical history: document and submit to the REMS Program using the Central Database.
Assess the patient’s concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents that either are unknown to the prescriber or pose a high risk of serious interaction using the processes and procedures established as a requirement of the REMS Program.
Verify in the Central Database that the patient and prescriber are enrolled and that the patient has no other active XYWAV or XYREM prescriptions through the processes and procedures established as a requirement of the REMS Program.
For patients previously dis-enrolled for suspicion of abuse, misuse or diversion: communicate all relevant patient history to the prescriber and re-enroll the patient if the prescriber and pharmacist agree.
Verify the patient’s prescription information, including patient name and two additional identifiers, prescriber name and information, dose, titration information (if applicable), number of refills, dosing directions, total quantity (days’ supply), and concomitant medications through the processes and procedures established as a requirement of the REMS Program.
Assess the patient's potential for abuse, misuse, and diversion by reviewing the alerts and Risk Management Report history in the Central Database.
For patients who request an early refill if abuse, misuse or diversion is suspected: discuss the request or concern with the prescriber.
Dispense no more than a one months' supply for the initial shipment.
Dispense no more than a three months' supply for subsequent shipments.
Before shipping
Verify the patient’s shipping address and that the patient or patientauthorized adult designee will be available to receive the shipment through the processes and procedures established as a requirement of the REMS.
Ship XYWAV and XYREM directly to each patient or a patient-authorized adult designee through the processes and procedures established as a requirement of the REMS.
Provide the patient with the XYWAV Patient Quick Start Guide, XYREM Patient Quick Start Guide, XYWAV Brochure for Pediatric Patients and their Caregivers, or XYREM Brochure for Pediatric Patients and their Caregivers with the first shipment.
After shipping
Track and verify receipt of each shipment of XYWAV and XYREM through the processes and procedures established as a requirement of the REMS.
Document and submit the shipment and receipt dates to the Central Database.
To Maintain Certification to Dispense, Every Year
For all relevant staff involved in dispensing: review the Pharmacy Training Program - Module A.
For all relevant staff involved in dispensing: successfully complete the Module A Knowledge Assessment and submit it to the REMS Program.
For all pharmacists involved in dispensing: review the Pharmacy Training Program – Modules A and B.
For all pharmacists involved in dispensing: successfully complete the Module A Knowledge Assessment and Module B Knowledge Assessment and submit it to the REMS Program.
Train all pharmacists involved in dispensing on the requirements of the REMS Program using Pharmacy Training Program – Module B.
At all times
Provide 24-7 toll-free access to a XYWAV and XYREM REMS Program pharmacist.
Ship XYWAV or XYREM directly to the patient or a patient-authorized adult designee using an overnight service.
Document and report all potential adverse events reported by all sources, including any CNS depression, respiratory depression, loss of consciousness, coma, and death to Jazz Pharmaceuticals.
Report lost, stolen, destroyed, or spilled drug to the Central Database using the Risk Management Report.
Monitor for all instances of patient and prescriber behavior that give rise to a reasonable suspicion of abuse, misuse, and diversion, including all requests for early refills, and all reports of lost, stolen, destroyed, or spilled drug. Report to Jazz Pharmaceuticals by documenting into the Central Database using the Risk Management Report.
| Risk Management Report |
Not distribute, transfer, loan, or sell XYWAV or XYREM.
Comply with audits carried out by Jazz Pharmaceuticals or a third party acting on behalf of Jazz Pharmaceuticals to ensure that all processes and procedures are in place and are being followed.
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 Xywav and Xyrem REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
02/09/2022
Modified to make changes to the XYWAV and XYREM Prescription Forms to decrease prescriber confusion when documenting the indication for use and signing the form.
12/09/2021
Modified to make changes to the dosing table structure on the Xywav Prescription Form to prevent confusion when the prescriber fills out the form.
08/12/2021
Modified to:
Make changes to the REMS materials to align with the new indication of Idiopathic Hypersomnia for Xywav
Make changes to the REMS assessment timetable
Change the reporting interval for the Knowledge, Attitude, and Behavior Surveys from annually to every other year
Make changes to the Patient Counseling Checklist to capture additional information regarding concomitant medication and alcohol use
02/11/2021
Modified to make revisions to the most common side effects in pediatric patients listed in the
Patient Counseling Checklist, Prescriber Brochure, the Xyrem and Xywav
Brochures for Pediatric Patients and their Caregivers, and the REMS Supporting
Document to conform with a recently approved prior approval supplement.
Modified to revise the REMS document, REMS supporting document, and appended
REMS materials to allow for the addition of an authorized generic for Xyrem.
07/21/2020
Modified to make changes to the REMS document, add an additional NDA number to include Xywav (NDA 212690),change the name of the REMS to the ‘Xywav and Xyrem REMS’,
update the REMS Document to include Xywav.In addition, this REMS modification updates the format and content of the REMS
Document consistent with the October 2017 Draft Guidance.
Changes to the REMS materials to add an additional NDA to include Xywav (NDA 212690),addition of the following new REMS materials: Xywav REMS
Prescription Form, Xywav REMS Patient Quick Start Guide, and Xywav REMS Brochure for Pediatric Patients and Their Caregivers.
10/26/2018
Modified to update the REMS document and materials to align with labeling changes related to the new pediatric indication.
07/15/2015
Modified to change the name of the REMS from the “Xyrem Success Program” to “Xyrem REMS Program” in the Medication Guide.
02/27/2015
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.
