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?
- What is the Xyrem REMS program and how does it work?
- Can you have narcolepsy and insomnia?
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.
References
- Lumryz Prescribing Information. Revised 10/2024. https://www.lumryz.com/_assets/pdfs/REF-00893_Lumryz_Prescribing_Information_Oct_2024.pdf
- Lumryz™ REMS (Risk Evaluation and Mitigation Strategy) https://www.lumryzrems.com/#Main
Read next
What is the difference between narcolepsy and idiopathic hypersomnia?
Although narcolepsy and idiopathic hypersomnia both have excessive daytime sleepiness as a common symptom, people with idiopathic hypersomnia have no sleep-onset rapid eye movement (REM) period, naps are unrefreshing (unlike with narcolepsy) and idiopathic hypersomnia is not associated with cataplexy. Idiopathic hypersomnia can be difficult to distinguish from narcolepsy, but sleep laboratory studies can help differentiate between them. Continue reading
What are the early signs of narcolepsy?
One of the earliest signs of narcolepsy is suddenly falling asleep during the daytime, even if you have had a full night’s sleep. This excessive sleepiness is like a “sleep attack” or an overwhelming sense of sleepiness that comes on quickly, and narcolepsy should be considered if a child or teen habitually falls asleep in class, or an adult finds themselves constantly dozing off at work, despite having had a full nights sleep. In between these sleep attacks, people with narcolepsy have normal levels of alertness, particularly if they are doing something that keeps their attention. Narcolepsy most commonly starts in young adults, aged 15 to 25, although it can occur at any age. Continue reading
What is the treatment for narcolepsy?
There is no cure for narcolepsy, but medications and lifestyle modifications can help manage symptoms such as excessive daytime sleepiness (EDS). Medications include: stimulants such as modafinil (Provigil) or armodafinil (Nuvigil) are usually tried first for narcolepsy because they are less addictive than older treatments such as methylphenidate (Aptensio XR, Concerta, Ritalin) or various amphetamines; solriamfetol (Sunosi), pitolisant (Wakix); selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine (Prozac, Sarafem) or serotonin and norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine (Effexor XR); tricyclic antidepressants, such as protriptyline (Vivactil), imipramine (Tofranil), and clomipramine (Anafranil); and sodium oxybate (Xyrem). Continue reading
See also:
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