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XYWAV - Jazz Pharmaceuticals, Inc.

Manufacturer
Jazz Pharmaceuticals, Inc.
Effective date
2025-07-28
Label type
RISK EVALUATION & MITIGATION STRATEGIES
Version
10
Source
full-release
Hydrated at
2026-06-04 22:50:46

Label at a glance#

ProductXYWAV
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS Administrative Information

Risks: serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion

Application Numbers: NDA 21196 (and Authorized Generic); NDA 212690

Application Holder: Jazz Pharmaceuticals, Inc (NDA 21196); Jazz Pharmaceuticals Ireland, Ltd. (NDA 212690)

Initial REMS Approval: 02/2015
Most Recent REMS Update: 07/2025

II. REMS Goal

REMS Goals

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:

  1. Informing prescribers, pharmacists, and patients of:
    1. The risk of significant CNS and respiratory depression associated with XYWAV and XYREM
    2. The contraindication of use of XYWAV and XYREM with sedative hypnotics and alcohol
    3. The potential for abuse, misuse, and overdose associated with XYWAV and XYREM
    4. The safe use, handling, and storage of XYWAV and XYREM
  2. Ensuring that pharmacy controls exist prior to filling prescriptions for XYWAV and XYREM that:
    1. Screen for concomitant use of sedative hypnotics and other potentially interacting agents
    2. Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM
    3. Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion

III. REMS Requirements

REMS Requirements

Jazz Pharmaceuticals must ensure that healthcare providers, patients, and the pharmacy comply with the following requirements:

REMS Participant Requirements

1. Healthcare providers who prescribe XYWAV and XYREM must:

REMS Participant Requirements

To become certified to prescribe

  1. Review the XYWAV and XYREM Prescribing Information.
  2. Review the following: Prescriber Brochure.
  3. Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS.

Before treatment initiation (first dose)

  1. Assess the patient’s health status to determine if XYWAV or XYREM is medically appropriate by screening for history of alcohol or substance abuse, sleep-related breathing disorders, compromised respiratory function, and depression or suicidality. Document and submit to the REMS using the product-specific Prescription Form.
  2. 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 using the product-specific Prescription Form.
  3. Counsel the patient on the serious risks associated with XYWAV and XYREM safe use, handling, and storage 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.
  4. Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS.
  5. Order the prescription using either the XYWAV Prescription Form or XYREM Prescription Form and submit it to the REMS.

Before treatment re-initiation.

  1. For patients dis-enrolled for suspicion of abuse, misuse or diversion: Communicate with the pharmacy regarding all relevant patient history and re-enroll the patient if the prescriber and pharmacist agree.
  2. For patients with a lapse in treatment of 6 months or longer: Order the prescription using either the XYWAV Prescription Form or XYREM Prescription Form and submit it to the REMS.

During treatment, within the first 3 months of starting treatment and recommended every 3 months thereafter.

  1. 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

  1. 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.
  2. Assess the patient’s potential for abuse, misuse, and diversion. Report all instances of behavior that give rise to a reasonable suspicion of abuse, misuse, or diversion, including all requests for early refills, and all reports of lost, stolen, destroyed, or spilled drug to the REMS.
  3. Report requests to disenroll a patient for suspected abuse, misuse, or diversion to the REMS.
2. Patients who are prescribed XYWAV and XYREM:

REMS Participant Requirements

Before treatment initiation

  1. Review 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.
  2. 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.
  3. Enroll in the REMS by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS.
  4. Complete the Patient Counseling Checklist with the pharmacist.

During treatment

  1. 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.
  2. 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

  1. Be monitored by your prescriber 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

  1. Complete the Patient Counseling Checklist with the pharmacist.

At all times

  1. Inform your prescriber and the pharmacy about any new medications you may be taking or medical conditions you may have.
3. The pharmacy that dispenses XYWAV and XYREM must:

REMS Participant Requirements

To become certified to dispense

  1. For all relevant staff involved in dispensing: review the Pharmacy Training Program – Module A.
  2. For all relevant staff involved in dispensing: successfully complete the Module A Knowledge Assessment and submit it to the REMS.
  3. For all pharmacists involved in dispensing: review the Pharmacy Training Program – Module A and B.
  4. For all pharmacists involved in dispensing: successfully complete the Module A Knowledge Assessment and Module B Knowledge Assessment and submit it to the REMS.
  5. Train all pharmacists involved in dispensing per the requirements of the Pharmacy Training Program – Module B.
  6. Establish processes and procedures to verify the following: the patient and prescriber are enrolled, the patient has no other active XYWAV or XYREM prescriptions.
  7. 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.
  8. 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.
  9. Establish processes and procedures to verify and document the patient has no other active prescriptions for oxybate products that overlap with the current prescription for XYWAV and XYREM by reviewing the following information received from other REMS for oxybate products: oxybate prescription information of prescriptions in process; oxybate prescription information of dispensed prescriptions that includes last dispense date, days’ supply, and prescriber’s name; and the patient and prescriber have not been disenrolled from any of the REMS for oxybate products for suspected abuse, misuse, or diversion.
  10. Establish processes and procedures to assess the patient’s potential for abuse, misuse, and diversion by reviewing the alerts and Risk Management Report histories in the REMS.
  11. Establish processes and procedures to provide 24-7 toll-free access to a XYWAV and XYREM REMS 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.
  12. Establish processes and procedures to reconcile XYWAV and XYREM inventory using the pharmacy’s inventory management system.

Before Dispensing

  1. 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 using the Central Database.
  2. For patients who report a change in their medication use or medical history: Document and submit the change to the REMS using the Central Database and the Patient Counseling Checklist (if required).
  3. 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.
  4. Verify the patient has no other active prescriptions for oxybate products that overlap with the current prescription for XYWAV or XYREM through the processes and procedures established as a requirement of the REMS by reviewing the following information received from other REMS for oxybate products: oxybate prescription information of prescriptions in process; oxybate prescription information of dispensed prescriptions that includes last dispense date, days’ supply, and prescriber’s name; and that the patient and prescriber have not been disenrolled from any other REMS for oxybate products for suspected abuse, misuse, or diversion. Document and submit to the REMS using the Central Database.
  5. Verify in the Central Database that the prescriber is certified, and the patient is enrolled in the REMS and that the patient has no other active XYWAV or XYREM prescriptions through the processes and procedures established as a requirement of the REMS.
  6. 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.
  7. 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.
  8. Assess the patient’s and their prescriber’s potential for abuse, misuse, and diversion by reviewing the alerts and Risk Management Report history in the Central Database.
  9. For patients who request an early refill or if abuse, misuse or diversion is suspected: Discuss the request or concern with the prescriber.
  10. Dispense no more than a one-month (30 day) supply for the initial shipment.
  11. Dispense no more than a three-month (90 day) supply for subsequent shipments.

Before Shipping

  1. Verify the patient’s shipping address and that the patient or patient-authorized adult designee will be available to receive the shipment through the processes and procedures established as a requirement of the REMS.
  2. 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.
  3. Provide new patients 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

  1. Track and verify receipt of each shipment of XYWAV and XYREM through the processes and procedures established as a requirement of the REMS.
  2. Document and submit the shipment and receipt dates to the Central Database.

To Maintain Certification to Dispense, Every Year

  1. For all relevant staff involved in dispensing: review the Pharmacy Training Program – Module A.
  2. For all relevant staff involved in dispensing: successfully complete the Module A Knowledge Assessment and submit it to the REMS.
  3. For all pharmacists involved in dispensing: review the Pharmacy Training Program – Modules A and B.
  4. For all pharmacists involved in dispensing: successfully complete the Module A Knowledge Assessment and Module B Knowledge Assessment and submit it to the REMS.
  5. Train all pharmacists involved in dispensing on the requirements of the REMS using Pharmacy Training Program – Module B.

At all times

  1. Provide 24-7 toll-free access to a XYWAV and XYREM REMS pharmacist.
  2. Ship XYWAV or XYREM directly to the patient or a patient-authorized adult designee using an overnight service.
  3. 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.
  4. Report lost, stolen, destroyed, or spilled drug to the Central Database using the Risk Management Report.
  5. 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.
  6. Not distribute, transfer, loan, or sell XYWAV or XYREM.
  7. Not stock XYWAV or XYREM in retail pharmacies.
  8. Maintain records of staff training and completion of knowledge assessments.
  9. Maintain records of inventory reconciliation using the pharmacy’s inventory management system.
  10. Maintain records of all processes and procedures including compliance with those processes and procedures.
  11. 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.

Jazz Pharmaceuticals must provide training to healthcare providers who prescribe XYWAV and XYREM.

REMS Applicant Requirements

The training includes the following educational material: Prescriber Brochure. The training must be available on a website and delivered by Jazz Pharmaceuticals.

Jazz Pharmaceuticals must provide training to the pharmacy that dispenses XYWAV and XYREM.

The training includes the following educational materials: Certified Pharmacy Training Program-Module A and B, Module A Knowledge Assessment, and Module B Knowledge Assessment. The training must be available on a website or delivered by Jazz Pharmaceuticals.

To support REMS operations, Jazz Pharmaceuticals must:

  1. Certify a pharmacy through a contract and distribute XYWAV and XYREM only to the certified pharmacy for dispensing.
  2. Not stock XYWAV or XYREM in retail pharmacies.
  3. Establish and maintain a REMS website, www.XYWAVXYREMREMS.com. The REMS website must include the capability to complete prescriber certification and patient enrollment, and the option to print the Prescribing Information, Medication Guide and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS website. The REMS website must not link back to the promotional product website(s).
  4. Make the REMS website fully operational and all REMS materials available through the website or call center within 180 calendar days of REMS modification (11/18/2024).
  5. Establish and maintain a REMS call center for REMS participants at 1-866-997-3688.
  6. Establish and maintain a validated, secure database, called the Central Database, of all REMS participants who have been or are enrolled and/or certified in the XYWAV and XYREM REMS. The database must include the following information: prescriber and patient enrollment status, all completed forms, prescription and shipment data as well as dosing, concomitant medications, behavior that raises suspicion of abuse, misuse, or diversion including all alerts and risk management reports.
  7. Ensure prescribers are able to submit the Prescriber Enrollment Form by facsimile, mail, email, and online.
  8. Ensure certified prescribers are able to submit the Patient Enrollment Form by facsimile, mail, and online.
  9. Ensure certified prescribers are able to submit the Prescription Form by facsimile, mail, and electronically.
  10. Ensure certified prescribers are able to add refills and renew prescriptions by phone, facsimile, mail, and electronically
  11. Ensure pediatric patients are able to change caregivers provided that the new caregiver has been counseled by the pharmacy on the serious risks and safe use of XYWAV and XYREM and acknowledges that he/she had any questions about XYWAV and XYREM answered before drug product is dispensed and shipped.
  12. Ensure patients are able to change certified prescribers.
  13. Ensure that the pharmacy is able to report lost, stolen, destroyed or spilled drug by completing a Risk Management Report in the Central Database.
  14. Ensure that the pharmacy is able to report repeated incidents of lost, stolen, destroyed, or spilled drug by creating an alert on the patient’s profile in the Central Database.
  15. Ensure that the pharmacy is able to verify and document in the Central Database the following information that is received from other REMS for oxybate products: patient has no other active, overlapping prescriptions for oxybate products by confirming oxybate prescription information of prescriptions in process; oxybate prescription information of dispensed prescriptions that includes last dispense date, days’ supply, and prescriber’s name; and that the patient and prescriber have not been disenrolled from any REMS for oxybate products for suspected abuse, misuse, or diversion.
  16. Ensure that prescribers are able to access alerts and Risk Management Report histories by phone.
  17. Ensure that the pharmacy is able to disenroll patients, in consultation with the prescriber and/or Jazz Pharmaceuticals, after review of incidents suggestive of abuse, misuse, or diversion by changing the patient’s enrollment status in the Central Database.
  18. Report patient and prescriber disenrollment in the XYWAV and XYREM REMS due to suspected abuse, misuse, or diversion to all other REMS for oxybate products by phone. Document in the Central database.
  19. Maintain a process to provide XYWAV and XYREM prescription information, including last dispense date, days’ supply, and prescriber’s name to other pharmacies upon request to verify that the named patient has no other active, overlapping prescriptions for oxybate products and that the patient and prescriber have not been disenrolled from the XYWAV and XYREM REMS for suspected abuse, misuse or diversion.
  20. Notify Prescribers within 2 business days after they become certified in the REMS.
  21. Provide the Prescriber Enrollment Form and the Prescriber Brochure to prescribers who (1) attempt to prescribe XYREM and XYWAV and are not yet certified or (2) inquire about how to become certified.
  22. Provide the certified pharmacy access to the database of certified prescribers and enrolled patients and disenrolled patients.

To ensure REMS participants’ compliance with the REMS, Jazz Pharmaceuticals must:

  1. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: XYREM distribution and dispensing; XYWAV distribution and dispensing, certification of prescribers, and the certified pharmacy; enrolled patients; and audits of REMS participants. These records must be readily available for FDA inspections.
  2. Establish a plan for addressing noncompliance with REMS requirements.
  3. Monitor certified prescribers and the certified pharmacy on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including de-certification.
  4. Monitor the certified pharmacy for timely reporting to Jazz Pharmaceuticals of all potential adverse events and any behavior by patients or prescribers enrolled in the REMS that raises suspicion of abuse, misuse or diversion.
  5. Monitor the Central Database on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified.
  6. Audit the certified pharmacy at least annually.
  7. Take reasonable steps to improve operations of and compliance with the requirements in the XYWAV and XYREM REMS based on monitoring and evaluation of the XYWAV and XYREM REMS.

IV. REMS Assessment Timetable

REMS Timetable for Submission Assessments

Jazz Pharmaceuticals must submit a REMS Assessment on April 26, 2022 and annually thereafter. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Jazz Pharmaceuticals must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the XYWAV and XYREM REMS:

Enrollment Forms

Prescriber

  1. Prescriber Enrollment Form

Patient

  1. Patient Enrollment Form

Training and Educational Materials

Prescriber

  1. Prescriber Brochure

Patient

  1. XYREM Patient Quick Start Guide
  2. XYREM Brochure for Pediatric Patients and their Caregivers
  3. XYWAV Patient Quick Start Guide
  4. XYWAV Brochure for Pediatric Patients and their Caregivers

Pharmacy

  1. Certified Pharmacy Training Program
  2. Module A Knowledge Assessment
  3. Module B Knowledge Assessment

Patient Care Forms

  1. XYREM Prescription Form
  2. XYWAV Prescription Form
  3. Patient Counseling Checklist

Other Materials

  1. Risk Management Report
  2. REMS website

VI. Statutory Elements

REMS Elements

This REMS is required under section 505-1 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Elements to Assure Safe Use:
    1. Health care providers who prescribe XYWAV and XYREM are specially certified under 505-1(f)(3)(A).
    2. Pharmacies that dispense XYWAV and XYREM are specially certified under 505-1(f)(3)(B).
    3. XYWAV and XYREM are dispensed to patients with evidence or other documentation of safe-use conditions under 505-1(f)(3)(D).
  2. Implementation System
  3. Timetable for Submission of Assessments

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e88548e-cd6c-4b2e-a954-1bb23670f612Product name120231010
b3e31acf-ce79-4bd9-845e-03c8d973021aProduct name120210203
a3ec038e-96ea-8cce-3e80-6c56853019f6Product name220170424

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use XYREM safely and effectively. See full prescribing information for XYREM. XYREM ® (sodium oxybate) oral solution, CIII Initial U.S. Approval: 2002SPL related document2025-07-01Jazz Pharmaceuticals, Inc. | Jazz Pharmaceuticals Ireland Limited20260514_32e860ba-14fb-48c4-a3d2-901685877339.zip!5f66234e-a8bf-4281-a5d7-57b1ff8468ba.xml
These highlights do not include all the information needed to use XYWAV safely and effectively. See full prescribing information for XYWAV. XYWAV ® (calcium, magnesium, potassium, and sodium oxybates) oral solution, CIII Initial U.S. Approval: 2002SPL related document2025-07-01Jazz Pharmaceuticals, Inc. | Jazz Pharmaceuticals Ireland Limited20260514_32e860ba-14fb-48c4-a3d2-901685877339.zip!5f66234e-a8bf-4281-a5d7-57b1ff8468ba.xml
These highlights do not include all the information needed to use SODIUM OXYBATE ORAL SOLUTION safely and effectively. See full prescribing information for SODIUM OXYBATE ORAL SOLUTION . SODIUM OXYBATE oral solution, CIII Initial U.S. Approval: 2002SPL related document2023-04-25Hikma Pharmaceuticals USA Inc. | Jazz Pharmaceuticals, Inc. | Jazz Pharmaceuticals Ireland Limited20260514_32e860ba-14fb-48c4-a3d2-901685877339.zip!5f66234e-a8bf-4281-a5d7-57b1ff8468ba.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XYWAVCALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATESJazz Pharmaceuticals, Inc.1e0ae43a-037f-42af-8e23-a0e51d75abe82025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: XYWAV

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