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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:
The risk of significant central nervous system (CNS) and respiratory depression
associated with LUMRYZ
The contraindication of use of LUMRYZ with sedative hypnotics or alcohol
The potential for abuse, misuse, and overdose associated with LUMRYZ
The safe use, handling, and storage of LUMRYZ
2. Ensuring that pharmacy controls exist prior to filling prescriptions for LUMRYZ that:
Screen for concomitant use of sedative hypnotics and other potentially interacting
agents
Monitor for inappropriate prescribing, misuse, abuse, and diversion of LUMRYZ
Notify prescribers when patients are receiving concomitant contraindicated
medications or there are signs of potential abuse, misuse, or diversion
Enroll in the REMS by completing the Prescriber Enrollment Form and
submitting it to the REMS.
| Prescriber Enrollment Form |
Before treatment initiation (first dose)
Assess the patient’s health status to determine if LUMRYZ is medically
appropriate by screening for history of alcohol and drug abuse, sleeprelated
breathing disorders, compromised respiratory function, depression
or suicidality. Document and submit to a certified pharmacy using the
Prescription Form.
| Prescription Form |
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.
| Prescription Form |
Counsel the patient on the serious risks and safe use, handling, and
| Patient Brochure |
Enroll the patient by completing and submitting the Patient Enrollment
Form to the REMS.
| Patient Enrollment Form |
Order the prescription using the Prescription Form and submit it to a
certified pharmacy.
| Prescription Form |
Before treatment re-initiation
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.
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.
| 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 Avadel CNS
Pharmaceuticals, LLC.
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.
| Risk Management Report |
Report requests to disenroll a patient for suspected abuse, misuse, or
diversion to the REMS using the Risk Management Report.
| Risk Management Report |
Receive counseling from the prescriber on the serious risks associated
with LUMRYZ and safe use, handling, and storage of LUMRYZ using the
Patient Brochure.
| Patient Brochure |
Enroll in the REMS by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS.
| Patient Enrollment Form |
Adhere to the safe use conditions described in the Patient Brochure.
| Patient Brochure |
Complete the Patient Counseling Checklist with the pharmacist based on
changes in medication and/or medical history.
| Patient Counseling Checklist |
During treatment; within the first 3 months of starting treatment and recommended
every 3 months thereafter
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
Inform your prescriber and the pharmacy about any new medications you
may be taking or medical conditions you may have.
Pharmacies that dispense LUMRYZ must:
To become certified to dispense
Designate an authorized representative to carry out the certification process
and oversee implementation and compliance with the REMS on behalf of the
pharmacy.
Have the authorized representative review Certified Pharmacy Training Program
– Pharmacy Staff Module and Pharmacist Module.
| Certified Pharmacy Training Program |
Have the authorized representative enroll in the REMS by completing and
submitting the Pharmacy Enrollment Form.
| Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing using the Certified Pharmacy
Training Program – Pharmacy Staff Module.
| Certified Pharmacy Training Program |
Have all relevant staff involved in dispensing successfully complete the
Pharmacy Staff Knowledge Assessment and submit it to the REMS.
| Pharmacy Staff Knowledge Assessment |
Train all pharmacists involved in dispensing using the Certified Pharmacy
Training Program – Pharmacy Staff Module and the Pharmacist Module.
| Certified Pharmacy Training Program |
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 verify the following: the patient and
prescriber are enrolled, the patient has no other active LUMRYZ prescriptions.
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.
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.
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.
| Risk Management Report |
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.
Establish processes and procedures to report each prescription filled for
LUMRYZ to all other REMS for oxybate products and document to the REMS.
Establish processes and procedures to reconcile LUMRYZ inventory using the
pharmacy’s inventory management system.
Establish processes and procedures to provide dispensing data and shipment
and receipt dates to the REMS.
Before dispensing
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.
| Patient Counseling Checklist |
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.
| Patient Counseling Checklist |
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.
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.
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.
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.
| Risk Management Report |
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.
| Patient Counseling Checklist |
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.
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.
For patients who request an early refill or if abuse, misuse or diversion is
suspected: Discuss the request or concern with the prescriber.
Dispense no more than a one-month (30 day) supply for the initial shipment.
Dispense no more than a three-month (90 day) supply for subsequent
shipments.
After dispensing, within 1 business day
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 shipping
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.
Ship LUMRYZ directly to each patient or a patient-authorized adult designee
through the processes and procedures established as a requirement of the
REMS.
Provide new patients with the Patient Brochure with their first shipment.
| Patient Brochure |
After shipping
Track and verify receipt of each shipment of LUMRYZ through the processes
and procedures established as a requirement of the REMS.
Document and submit the dispensing data, and shipment and receipt dates to
the REMS.
To maintain certification to dispense
Have a new authorized representative review Certified Pharmacy Training
Program – Pharmacy Staff Module and Pharmacist Module.
| Certified Pharmacy Training Program |
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 year
Train all relevant staff involved in dispensing LUMRYZ using the Certified
Pharmacy Training Program – Pharmacy Staff Module.
| Certified Pharmacy Training Program |
Have all relevant staff involved in dispensing LUMRYZ successfully complete the
Pharmacy Staff Knowledge Assessment and submit it to the REMS.
| Pharmacy Staff Knowledge Assessment |
Train all pharmacists involved in dispensing LUMRYZ using the Certified
Pharmacy Training Program – Pharmacy Staff Module and Pharmacist Module.
| Certified Pharmacy Training Program |
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.
| Pharmacy Staff Knowledge Assessment |
| Pharmacist Knowledge Assessment |
At all times
Provide 24-7 toll-free access to a REMS trained pharmacist.
Ship LUMRYZ 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 Avadel CNS Pharmaceuticals, LLC.
Report lost, stolen, destroyed, or spilled drug to the REMS using the Risk
Management Report.
| Risk Management Report |
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.
| Risk Management Report |
Report requests to disenroll a patient for suspected abuse, misuse, or diversion
to the REMS using the Risk Management Report.
| Risk Management Report |
Not distribute, transfer, loan, or sell LUMRYZ.
Not stock LUMRYZ in retail pharmacies.
Maintain records of staff training and completion of knowledge assessments.
Maintain records of inventory reconciliation using the pharmacy’s inventory
management system.
Maintain records of all processes and procedures including compliance with
those processes and procedures.
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.
Wholesalers, distributors, and other entities that distribute LUMRYZ must:
To be able to
distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified pharmacies.
Train all relevant staff involved in distributing LUMRYZ on the
REMS requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of all drug distributions.
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.
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 Lumryz 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
10/31/2023
Modifications to the REMS consist of: updates to the REMS Document
to align with the current Format and Content of a REMS Document Guidance for
Industry and the REMS Document Technical Conformance Guide; changes to the
reporting of the confirmation for prescriptions filled for Lumryz to the REMS; and
changes to the Lumryz Prescription Form to comply with certain state requirements for
paper prescriptions. Additionally, all REMS materials are aligned to the following
changes to the REMS requirements:
Prescribers are required to document and submit all instances of behavior that
give rise to a reasonable suspicion of abuse, misuse, or diversion; and report
requests to disenroll a patient for suspected abuse, misuse, or diversion to the
REMS using the Risk Management Report.
Pharmacies are required to obtain oxybate prescription information of last
dispense date, days’ supply, and prescriber’s name by contacting all other REMS
for oxybate products.
Changes to the REMS Dispense Authorization (RDA) to include that the Patient
Counseling Checklist is completed as required and the alerts and Risk
Management Report history for the patient and their prescriber are reviewed by
the pharmacist.
The Applicant is required to ensure prescribers are able to access patient alerts
and Risk Management Report histories.
The Applicant is required to 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.
05/01/2023
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.
