What is Xyrem REMS?

Xyrem REMS refers to the program through which Xyrem can be prescribed by a doctor and through which Xyrem can be dispensed to a patient.

• REMS stands for Risk Evaluation and Mitigation Strategy and the purpose of the program is to manage known or potential serious risks associated with a drug.
• The FDA requires REMS programs for certain drugs to ensure that the benefits of the drug outweigh the risks.
• The Xyrem REMS program is actually called the Xywav and Xyrem REMS.
• The program ensures that only Xyrem (and Xywav) are dispensed only from the Certified Pharmacy.

Xyrem is a central nervous system depressant that may be used to treat cataplexy or excessive daytime sleepiness in adults and children aged 7 years and older with narcolepsy. Because Xyrem 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.

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

• Be familiar with the Xyrem datasheet and prescribing information. This includes how to screen people for a history of alcohol or substance abuse or other medical conditions that may prohibit the use of Xyrem
• Know how to educate and counsel people prescribed Xyrem and tell them about potential drug interactions
• Use the correct Xyrem REMS program Prescription form for new prescriptions and also refills and renewals of Xyrem prescriptions
• Provide new patients with a Xyrem REMS Program Patient Quick Start Guide.

Each new person prescribed Xyrem must complete a one-time enrollment in the Xyrem REMS Program Patient Enrollment Form and be able to answer patient questions about usage, storage, the risks associated with Xyrem, and where to obtain it from.

The prescription for Xyrem can only be filled by the central certified pharmacy, not your local pharmacy. This is the only pharmacy in the United States permitted to fill the prescription and send it directly to patients. This pharmacy also:

• Gives the patient access to a pharmacist 24 hours a day, 7 days a week to answer questions about Xyrem
• Provides an overnight delivery service (includes Saturdays) but only the patient or a designated adult can sign for the delivery
• Follows up your prescription with a nurse case manager two days after delivery to answer questions.

Related questions

• What is the difference between Xywav vs Xyrem?
• Will Xyrem show up on a drug test?
• What is the difference between Lumryz vs Xyrem?