FDA.reportPublic FDA data

LUMRYZ - Avadel CNS Pharmaceuticals, LLC

Manufacturer
Avadel CNS Pharmaceuticals, LLC
Effective date
2025-03-28
Label type
Risk Evaluation & Mitigation Strategies
Version
12
Source
full-release
Hydrated at
2026-06-04 22:50:38

Label at a glance#

ProductLUMRYZ
Label structure6 sections

Label contents#

Full prescribing information#

I. ADMINISTRATIVE INFORMATION

REMS ADMINISTRATIVE INFORMATION

Risk: serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion
Application Number: NDA 214755
Application Holder: Avadel CNS Pharmaceuticals, LLC
Initial REMS Approval: 05/2023
Most Recent REMS Update: 03/2025

II. REMS GOAL

REMS GOALS

The goal of the LUMRYZ REMS is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of LUMRYZ by:

  1. Informing prescribers, pharmacists, and patients of:
    1. The risk of significant central nervous system (CNS) and respiratory depression associated with LUMRYZ
    2. The contraindication of use of LUMRYZ with sedative hypnotics or alcohol
    3. The potential for abuse, misuse, and overdose associated with LUMRYZ
    4. The safe use, handling, and storage of LUMRYZ
  2. Ensuring that pharmacy controls exist prior to filling prescriptions for LUMRYZ that:
    1. Screen for concomitant use of sedative hypnotics and other potentially interacting agents
    2. Monitor for inappropriate prescribing, misuse, abuse, and diversion of LUMRYZ
    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

REMS PARTICIPANT REQUIREMENTS

Avadel CNS Pharmaceuticals, LLC must ensure that healthcare providers, patients, pharmacies, and wholesalers, distributors, and other entities that distribute LUMRYZ comply with the following requirements:

1. Healthcare providers who prescribe LUMRYZ must:
To become certified to prescribe1. Review the drug’s 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)4. Assess the patient’s health status to determine if LUMRYZ is medically appropriate by screening for history of alcohol and drug abuse, sleep-related breathing disorders, compromised respiratory function, depression or suicidality. Document and submit to a certified pharmacy using the Prescription Form.
5. Assess the patient’s health status to determine if LUMRYZ is medically appropriate by screening for concomitant use of sedative hypnotics, other CNS depressants or other potentially interacting agents. Document and submit to a certified pharmacy using the Prescription Form.
6. Counsel the patient on the serious risks and safe use, handling, and storage of LUMRYZ using the Patient Brochure or the Pediatric Patients and their Caregivers Brochure.
7. Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS.
8. Order the prescription using the Prescription Form and submit it to a certified pharmacy.
Before treatment re-initiation9. For patients disenrolled 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.
10. For patients with a lapse in treatment of 6 months or longer: Order the prescription using the Prescription Form and submit it to a certified pharmacy.
During treatment; within the first 3 months of starting treatment and recommended every 3 months thereafter11. 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 times12. 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 Avadel CNS Pharmaceuticals, LLC.
13. Assess the patient’s potential for abuse, misuse, and diversion. Document and submit 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 using the Risk Management Report.
14. Report requests to disenroll a patient for suspected abuse, misuse, or diversion to the REMS using the Risk Management Report.

REMS PARTICIPANT REQUIREMENTS

2. Patients who are prescribed LUMRYZ:
Before treatment initiation1. Review the Patient Brochure or the Pediatric Patients and their Caregivers Brochure.
2. Receive counseling from the prescriber on the serious risks associated with LUMRYZ and safe use, handling, and storage of LUMRYZ using the Patient Brochure or the Pediatric Patients and their Caregivers Brochure.
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 treatment5. Adhere to the safe use conditions described in the Patient Brochure or the Pediatric Patients and their Caregivers Brochure.
6. Complete the Patient Counseling Checklist with the pharmacist based on changes in medication and/or medical history.
During treatment; within the first 3 months of starting treatment and recommended every 3 months thereafter7. 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 longer8. Complete the Patient Counseling Checklist with the pharmacist.
At all times9. Inform your prescriber and the pharmacy about any new medications you may be taking or medical conditions you may have.

REMS PARTICIPANT REQUIREMENTS

3. Pharmacies that dispense LUMRYZ must:
To become certified to dispense1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
2. Have the authorized representative review Certified Pharmacy Training Program - Pharmacy Staff Module and Pharmacist Module.
3. Have the authorized representative successfully complete the Pharmacy Staff Knowledge Assessment and Pharmacist Knowledge Assessment and submit both to the REMS.
4. Have the authorized representative enroll in the REMS by completing and submitting the Pharmacy Enrollment Form.
5. Train all relevant staff involved in dispensing using the Certified Pharmacy Training Program - Pharmacy Staff Module.
6. Have all relevant staff involved in dispensing successfully complete the Pharmacy Staff Knowledge Assessment and submit it to the REMS.
7. Train all pharmacists involved in dispensing using the Certified Pharmacy Training Program - Pharmacy Staff Module and the Pharmacist Module.
8. Have all pharmacists involved in dispensing successfully complete the Pharmacy Staff Knowledge Assessment and Pharmacist Knowledge Assessment and submit both to the REMS.
9. 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.
10. Establish processes and procedures to verify the following: the patient and prescriber are enrolled, the patient has no other active LUMRYZ prescriptions.
11. Establish processes and procedures to verify and document the following by contacting all other REMS for oxybate products: the patient has no other active prescriptions that overlap with the current prescription for LUMRYZ by obtaining oxybate prescription information of 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.
12. Establish processes and procedures to verify all 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.
13. 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.
14. Establish processes and procedures to provide 24-7 toll-free access to a LUMRYZ REMS trained 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 LUMRYZ to the patient or patient-authorized adult designee using an overnight service.
15. Establish processes and procedures to report each prescription filled for LUMRYZ to all other REMS for oxybate products and document to the REMS.
16. Establish processes and procedures to reconcile LUMRYZ inventory using the pharmacy’s inventory management system.
17. Establish processes and procedures to provide dispensing data and shipment and receipt dates to the REMS.
Before dispensing18. For new patients and existing patients who restart treatment after not receiving LUMRYZ for 6 months or longer: Counsel the patient using the Patient Counseling Checklist. Document and submit to the REMS.
19. For patients who report a change in their medication use or medical history: Document and submit the change to the REMS using the Patient Counseling Checklist.
20. Assess the patient’s concomitant use of sedative hypnotics, other CNS depressants, or potentially interacting agents that either are unknown to the prescriber or pose a high risk of serious interaction through the processes and procedures established as a requirement of the REMS.
21. Verify in this REMS that the patient has no other active LUMRYZ prescriptions through the processes and procedures established as a requirement of the REMS. Document and submit to the REMS.
22. Verify the following by contacting all other REMS for oxybate products through the processes and procedures established as a requirement of the REMS: the patient has no other active prescriptions for oxybate products that overlap with the current prescription for LUMRYZ by obtaining oxybate prescription information of last dispense date, days’ supply, and prescriber’s name; and 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.
23. 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 REMS. Document the confirmation to the REMS.
24. Obtain authorization by contacting the REMS to verify the pharmacy is certified, the prescriber is certified, the patient is enrolled, the Patient Counseling Checklist is completed as required, the alerts and Risk Management Report history for the patient and their prescriber are reviewed by the pharmacist, and the patient has no active, overlapping prescriptions for oxybate products.
25. For patients previously disenrolled for suspicion of abuse, misuse, or diversion: Communicate all relevant patient history to the prescriber and determine whether to re-enroll the patient if the prescriber and pharmacist agree.
26. 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.
27. For patients who request an early refill or if abuse, misuse or diversion is suspected: Discuss the request or concern with the prescriber.
28. Dispense no more than a one-month (30 day) supply for the initial shipment.
29. Dispense no more than a three-month (90 day) supply for subsequent shipments.
After dispensing, within 1 business day30. Report each prescription filled for LUMRYZ to all REMS for oxybate products through the processes and procedures established as a requirement of the REMS. Document and submit to the REMS.
Before shipping31. 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.
32. Ship LUMRYZ directly to each patient or a patient-authorized adult designee through the processes and procedures established as a requirement of the REMS.
33. Provide new patients with the Patient Brochure or the Pediatric Patients and their Caregivers Brochure with their first shipment.
After shipping34. Track and verify receipt of each shipment of LUMRYZ through the processes and procedures established as a requirement of the REMS.
35. Document and submit the dispensing data, and shipment and receipt dates to the REMS.
To maintain certification to dispense36. Have a new authorized representative review Certified Pharmacy Training Program – Pharmacy Staff Module and Pharmacist Module.
37. Have a new authorized representative successfully complete the Pharmacy Staff Knowledge Assessment and Pharmacist Knowledge Assessment and submit both to the REMS.
38. Have a new authorized representative enroll in the REMS by completing the Pharmacy Enrollment Form and submitting it to the REMS.
To maintain certification to dispense, every year39. Train all relevant staff involved in dispensing LUMRYZ using the Certified Pharmacy Training Program - Pharmacy Staff Module.
40. Have all relevant staff involved in dispensing LUMRYZ successfully complete the Pharmacy Staff Knowledge Assessment and submit it to the REMS.
41. Train all pharmacists involved in dispensing LUMRYZ using the Certified Pharmacy Training Program - Pharmacy Staff Module and Pharmacist Module.
42. Have all pharmacists involved in dispensing LUMRYZ successfully complete the Pharmacy Staff Knowledge Assessment and Pharmacist Knowledge Assessment and submit both knowledge assessments to the REMS.
At all times43. Provide 24-7 toll-free access to a REMS trained pharmacist.
44. Ship LUMRYZ directly to the patient or a patient-authorized adult designee using an overnight service.
45. Document and report all potential adverse events reported by all sources, including any CNS depression, respiratory depression, loss of consciousness, coma, and death to Avadel CNS Pharmaceuticals, LLC.
46. Report lost, stolen, destroyed, or spilled drug to the REMS using the Risk Management Report.
47. Monitor 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 the REMS by completing and submitting a Risk Management Report.
48. Report requests to disenroll a patient for suspected abuse, misuse, or diversion to the REMS using the Risk Management Report.
49. Not distribute, transfer, loan, or sell LUMRYZ.
50. Not stock LUMRYZ in retail pharmacies.
51. Maintain records of staff training and completion of knowledge assessments.
52. Maintain records of inventory reconciliation using the pharmacy’s inventory management system.
53. Maintain records of all processes and procedures including compliance with those processes and procedures.
54. Comply with audits carried out by Avadel CNS Pharmaceuticals, LLC or a third party acting on behalf of Avadel CNS Pharmaceuticals, LLC to ensure all processes and procedures are in place and are being followed.

REMS PARTICIPANT REQUIREMENTS

4. Wholesalers, distributors, and other entities that distribute LUMRYZ must:
To be able to distribute1. Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
2. Train all relevant staff involved in distributing LUMRYZ on the REMS requirements.
At all times3. Distribute only to certified pharmacies.
4. Maintain records of all drug distributions.
5. Comply with audits carried out by Avadel CNS Pharmaceuticals, LLC or a third party acting on behalf of Avadel CNS Pharmaceuticals, LLC to ensure all processes and procedures are in place and are being followed.

REMS APPLICANT REQUIREMENTS

Avadel CNS Pharmaceuticals, LLC must provide training to healthcare providers who prescribe LUMRYZ.
The training includes the following educational material: Prescriber Brochure. The training must be available on the REMS website and delivered by Avadel CNS Pharmaceuticals, LLC.

Avadel CNS Pharmaceuticals, LLC must provide training to the pharmacies that dispense LUMRYZ.
The training includes the following educational materials: Certified Pharmacy Training Program - Pharmacy Staff Module and Pharmacist Module, Pharmacy Staff Knowledge Assessment, and Pharmacist Knowledge Assessment. The training must be available on the REMS website and delivered by Avadel CNS Pharmaceuticals, LLC.

To support REMS operations, Avadel CNS Pharmaceuticals, LLC must:

  1. Not stock LUMRYZ in retail pharmacies.
  2. Authorize dispensing for each patient after verifying the pharmacy is certified, the prescriber is certified, the patient is enrolled, the Patient Counseling Checklist is completed as required, the alerts and Risk Management Report history for the patient and their prescriber are reviewed by the pharmacist, and the patient has no active, overlapping prescriptions for oxybate products.
  3. Establish and maintain a REMS website: www.LUMRYZREMS.com. The REMS website must include the capability to complete prescriber certification online, complete pharmacy staff and pharmacist knowledge assessments, the capability to enroll and manage patients online, including the capability for pharmacies to obtain an authorization to dispense, complete the Risk Management Report, complete the Patient Counseling Checklist, 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 to promotional product website(s).
  4. Make the REMS website fully operational and all REMS materials available through the REMS website and call center by the date LUMRYZ is first commercially distributed.
  5. Establish and maintain a REMS call center for REMS participants at 1-877-453-1029.
  6. Establish and maintain validated, secure, separate and distinct databases of all REMS participants enrolled, certified and/or disenrolled in the REMS, including a patient database, certified prescriber database, certified pharmacy database, and disenrolled prescriber database that will be queried independently through electronic verification.
  7. Ensure prescribers are able to submit the Prescriber Enrollment Form online and by fax.
  8. Ensure certified prescribers are able to submit the Patient Enrollment Form online and by fax.
  9. Ensure certified prescribers are able to submit the Prescription Form by fax and mail to a certified pharmacy.
  10. Ensure certified prescribers are able to add refills and renew prescriptions by phone, fax, mail, and electronically.
  11. Ensure pediatric patients are able to change caregivers provided that the new caregiver has been counseled by a certified pharmacy on the serious risks and safe use of the drug and acknowledges that he/she had any questions about LUMRYZ answered before drug product is dispensed and shipped.
  12. Ensure patients are able to change certified prescribers.
  13. Ensure pharmacies are able to submit the Pharmacy Enrollment Form by fax.
  14. Ensure certified pharmacies are able to obtain authorization to dispense LUMRYZ online, including through the pharmacy’s pharmacy management system, and by phone.
  15. Ensure certified pharmacies and prescribers are able to report lost, stolen, destroyed or spilled LUMRYZ by completing and submitting a Risk Management Report to the REMS online and by fax.
  16. Ensure certified pharmacies are able to submit the Patient Counseling Checklist by fax and online.
  17. Ensure certified pharmacies are able to verify that the patient has no other active, overlapping prescriptions for oxybate products and that the patient and prescriber have not been disenrolled from any REMS for oxybate products for suspected abuse, misuse, or diversion by phone.
  18. Ensure certified pharmacies are able to report by phone and online that the patient has no other active, overlapping prescriptions of oxybate products and that the patient and prescriber have not been disenrolled from any REMS for oxybate products for suspected abuse, misuse, or diversion.
  19. Ensure certified pharmacies and certified prescribers are able to create an alert in the patient’s profile for repeated incidents of lost, stolen, destroyed, or spilled drug by completing and submitting a Risk Management Report online and by fax.
  20. Ensure certified pharmacies and prescribers are able to access alerts and Risk Management Report histories by phone and online.
  21. Ensure certified pharmacies are able to report completion of the review of alerts and Risk Management Report histories of the patient and their prescriber by the pharmacist by submitting confirmation by phone and online.
  22. Ensure certified pharmacies and certified prescribers are able to request to disenroll patients for incidents suggestive of abuse, misuse, or diversion by completing and submitting a Risk Management Report online and by fax.
  23. Ensure certified pharmacies are able to request to disenroll a prescriber for suspected abuse, misuse, or diversion by completing and submitting a Risk Management Report online and by fax.
  24. Report patient and prescriber disenrollment in the LUMRYZ REMS due to suspected abuse, misuse, or diversion to all other REMS for oxybate products by phone. Document in the LUMRYZ REMS databases.
  25. Maintain a process to provide LUMRYZ 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 LUMRYZ REMS for suspected abuse, misuse, or diversion.
  26. Notify prescribers and pharmacies within two (2) business days after they become certified in the REMS.
  27. Provide the Prescriber Enrollment Form and the Prescriber Brochure to prescribers who (1) attempt to prescribe LUMRYZ and are not yet certified or (2) inquire about how to become certified.
  28. Provide certified pharmacies access to the REMS databases of certified prescribers, enrolled patients, and disenrolled patients.
  29. Provide wholesalers-distributors access to list of certified pharmacies.

To ensure REMS participants’ compliance with the REMS, Avadel CNS Pharmaceuticals, LLC must:

  1. Verify annually that the authorized representative’s name and contact information correspond to those of the current designated authorized representative for the pharmacy. If different, the pharmacy must be required to re-certify with a new authorized representative.
  2. Maintain adequate records to demonstrate REMS requirements have been met, including, but not limited to, records of: LUMRYZ distribution and dispensing; certification of prescribers and pharmacies; enrolled patients; and audits of REMS participants. These records must be readily available for FDA inspections.
  3. Establish a plan for addressing noncompliance with REMS requirements.
  4. Monitor certified prescribers, certified pharmacies, wholesaler-distributors, and other entities that distribute LUMRYZ on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if noncompliance is identified, including de-certification.
  5. Monitor certified prescribers and pharmacies for timely reporting to Avadel CNS Pharmaceuticals, LLC of all potential adverse events and any behavior by patients or prescribers enrolled in the REMS that raises suspicion of abuse, misuse, or diversion.
  6. Audit certified pharmacies within 90 calendar days after the pharmacy places its first order of LUMRYZ, and annually thereafter, to ensure all REMS processes and procedures are in place, functioning, and comply with REMS requirements.
  7. Audit wholesalers, distributors, and other entities that distribute LUMRYZ within 90 calendar days after LUMRYZ is first commercially distributed and annually thereafter to ensure all REMS processes and procedures are in place, functioning, and comply with REMS requirements.
  8. Take reasonable steps to improve operations of and compliance with the requirements in the REMS based on monitoring and evaluation of the REMS.

IV. REMS ASSESSMENT TIMETABLE

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Avadel CNS Pharmaceuticals, LLC must submit REMS Assessments at 6 months, 12 months, and annually thereafter from the date of the initial approval of the REMS. 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. Avadel CNS Pharmaceuticals, LLC must submit each assessment so it will be received by FDA on or before the due date.

V. REMS Materials

REMS MATERIAL

The following materials are part of the LUMRYZ REMS:

Enrollment Forms:

Prescriber:

  1. Prescriber Enrollment Form

Patient:

  1. Patient Enrollment Form

Pharmacy:

  1. Pharmacy Enrollment Form

Training and Educational Materials:

Prescriber:

  1. Prescriber Brochure

Patient:

  1. Patient Brochure
  2. Pediatric Patients and their Caregivers Brochure

Pharmacy:

  1. Certified Pharmacy Training Program
  2. Pharmacy Staff Knowledge Assessment
  3. Pharmacist Knowledge Assessment

Patient Care Forms:

  1. Prescription Form
  2. Patient Counseling Checklist

Other Materials:

  1. Risk Management Report
  2. REMS Program 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:
    • Health care providers who prescribe LUMRYZ are specially certified under 505-1(f)(3)(A)
    • Pharmacies that dispense LUMRYZ are specially certified under 505-1(f)(3)(B)
    • LUMRYZ is 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 LUMRYZ ® safely and effectively. See full prescribing information for LUMRYZ. LUMRYZ (sodium oxybate) for extended-release oral suspension, CIII Initial U.S. Approval: 2002SPL related document2026-09-08Alkermes, Inc.20250529_234b27b8-5829-4e83-a73e-3b0b7a2bf417.zip!1470f4ea-25ad-4d5d-b1b2-98c9341c1796.xml

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.