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Can any doctor prescribe Xyrem?

Medically reviewed by Carmen Fookes, BPharm. Last updated on June 14, 2020.

Official Answer

by Drugs.com
  • No. Only doctors enrolled in the Xyrem REMS program can prescribe Xyrem.
  • To become certified, doctors must complete a one-time enrollment and be familiar with the Xyrem prescribing information.
  • This includes knowing how to screen for alcohol or substance abuse, interacting medicines, or medical conditions that may not be compatible with Xyrem use.
  • In addition, Xyrem can only be dispensed from the central certified pharmacy. This is the only pharmacy that can supply and distribute Xyrem across the United States.

Xyrem (sodium oxybate) is a CNS depressant that may be used to treat narcolepsy.

Doctors must become certified in the Xyrem REMS program before they can prescribe Xyrem. The Xyrem REMS program has been developed in conjunction with the FDA and REMS stands for Risk Evaluation and Mitigation Strategy. REMS programs are required by the FDA to ensure potentially serious risks associated with a drug, such as Xyrem, are evaluated and managed properly.

To become certified, a doctor must complete a one-time Xyrem REMS Program Prescriber Enrollment Form and submit it to the XYREM REMS Program via fax, email, or mail. The enrollment form may be found on the xyremrems.com website.

In addition to completing the enrollment form doctors must:

  • 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.

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