What is Lumryz REMS?

Lumryz REMS refers to the safety program through which Lumryz can be prescribed by a doctor and through which Lumryz can be dispensed to a patient. REMS stands for Risk Evaluation and Mitigation Strategy and Lumryz REMS is required by the FDA (Food and Drug Administration) to ensure the potential benefits of Lumryz outweigh its risks.

Doctors must become certified in the Lumryz REMS program before they can prescribe Lumryz. To become certified, doctors must complete a one-time Lumryz REMS Program Prescriber Enrollment Form and submit it to the Lumryz REMS Program via fax or online. They must also:

• Be familiar with the Lumryz Prescribing Information and prescriber brochure. This includes how to screen people for a history of alcohol or substance abuse or other medical conditions that may prohibit the use of Lumryz
• Know how to educate and counsel people prescribed Lumryz and tell them about potential drug interactions
• Use the correct Lumryz REMS program Prescription form for new prescriptions (not needed for refills and renewals unless there has been a lapse in treatment of 6 months or longer)
• Provide new patients with a Lumryz Patient Brochure that provides information about how to obtain Lumryz, how to use it properly, and how to store it safely.

At all times, the prescriber will:

• 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
• Report requests to disenroll a patient for suspected abuse, misuse, or diversion to the REMS using the Risk Management Report.

Related questions

• What is the difference between Lumryz vs Xyrem?
• How does Xyrem work for narcolepsy?
• Is Xyrem a controlled substance / narcotic drug of abuse?

How do Patients enrol in Lumryz REMS?

Each new person prescribed Lumryz must complete a one-time enrollment in the Lumryz REMS Program (see here for the Lumryz Patient Enrollment Form) and the prescriber has given them enough information so that they understand:

• How to enroll and take part in the Lumryz REMS
• The information in the Patient Brochure
• The benefits and serious risks associated with Lumryz
• The safe use, handling and storage of Lumryz.

Lumryz REMS also requires patients to complete the Patient Counseling Checklist with the pharmacist.

Your healthcare provider will evaluate you within the first 3 months of taking Lumryz and may reevaluate you every 3 months while you are taking Lumryz. Tell your and the pharmacy about any changes in your medications or medical conditions.

What pharmacies dispense Lumryz?

The prescription for Lumryz can only be filled by a certified pharmacy, not your local pharmacy. This pharmacy also:

• Gives the patient access to a pharmacist 24 hours a day, 7 days a week to answer questions about Lumryz
• Provides an overnight delivery service (includes Saturdays) but only the patient or a designated adult can sign for the delivery

During treatment, within the first 3 months of starting treatment and recommended every 3 months thereafter, the prescriber will 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/or drug-seeking behavior

What is Lumryz?

Lumryz is a central nervous system depressant that may be used to treat cataplexy or excessive daytime sleepiness in adults and children aged 7 and older with narcolepsy. Because Lumryz contains sodium oxybate (GHB), a known street drug with a high potential for abuse and serious side effects, the FDA has restricted who can prescribe it and who can dispense it.