Program Overview

Because of the risks of CNS depression, abuse, and misuse, XYREM is available only through a restricted distribution program called the XYREM REMS Program using the central pharmacy that is specially certified. Prescribers and patients must enroll in the program.1

The XYREM REMS Program is designed to ensure that prescribers and patients are educated on and understand the risks and safe use conditions of XYREM and agree to follow the requirements of the XYREM REMS Program.2 The program also ensures that XYREM is dispensed from the specially certified central pharmacy.2

XYREM REMS Program Components

Prescribers

XYREM will be prescribed only by prescribers who are enrolled in the XYREM REMS Program.1,2

Patients

XYREM will be dispensed and shipped only to patients who are enrolled in the XYREM REMS Program with documentation of safe use conditions.1,2

Certified Pharmacy

XYREM will be dispensed only by the specially certified central pharmacy.1,2

Need Help? Have Questions?

Call the XYREM REMS Program hotline anytime.

The Certified Pharmacy provides 24/7 toll-free access to a pharmacist to help answer any questions or concerns the prescriber, office staff, or patients may have regarding safety, dosing, and patient care.

Frequently Asked Questions

The required components of the XYREM REMS Program include1,2:

  • Medication Guide
  • Healthcare providers who prescribe XYREM are specially certified
  • XYREM will be dispensed only by the specially certified central pharmacy
  • XYREM will be dispensed and shipped only to patients who are enrolled in the XYREM REMS Program with documentation of safe use conditions

In 2007, the FDA began replacing Risk Management Programs (RMPs) and Risk Minimization Action Plans (RiskMAPs) with Risk Evaluation and Mitigation Strategies (REMS).3 The XYREM Success Program® was one of 16 programs that was considered a “deemed REMS” program in 2008.4,5 The FDA approved the XYREM REMS Program on February 27, 2015.5

Editable versions of the XYREM REMS Program Prescriber Enrollment Form and XYREM REMS Program Patient Enrollment Form, as well as secure online prescriber and patient enrollment, are available at XYREMREMS.com. All required forms can also be obtained by contacting a Jazz Pharmaceuticals Specialty Sales Consultant (SSC) or calling the Certified Pharmacy. XYREM REMS Program Prescription Forms are not available online.

The XYREM REMS Program education material can be downloaded from XYREMREMS.com. The XYREM REMS Program education material may also be obtained by contacting a Jazz Pharmaceuticals Specialty Sales Consultant (SSC) or calling the Certified Pharmacy.