TELL ME, wHAT IS THE XYREM® REMS PROGRAM?

TELL ME, wHAT IS THE XYREM® REMS PROGRAM?

XYREM patient screening, counseling, and evaluation.

All prescribers must screen, counsel, and evaluate their patients before prescribing XYREM.1

  • Prescribers will screen each prospective XYREM patient for certain medical conditions and concomitant medications.1

Prescriber screening of prospective XYREM patients.

Prescribers will screen each prospective XYREM patient for...1

  • History of alcohol or substance abuse.
  • History of sleep-related breathing disorders.
  • History of compromised respiratory function.
  • Concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents.
  • History of depression or suicidality.

The Certified Pharmacy will also screen each prospective XYREM patient.

  • The Certified Pharmacy will also screen each prospective XYREM patient for certain medical conditions and concomitant medications.1

Certified Pharmacy screening of prospective XYREM patients.

The Certified Pharmacy will specifically screen each prospective XYREM patient for…1

  • Breathing disorders, including sleep apnea, asthma, and COPD.
  • History of depression, suicidality, and drug or alcohol abuse.
  • Seizure disorders.
  • Hepatic impairment.
  • High blood pressure, heart problems, kidney problems, or salt-restricted diet.
  • Potentially interacting agents: sedative hypnotics; alcohol; sedating antidepressants, antipsychotics, or anti-epileptics; general anesthetics; muscle relaxants; opioid analgesics; valproate drugs; and illicit CNS depressants (eg, heroin, gamma-hydroxybutyrate [GHB]).
  • The Certified Pharmacy will contact the prescriber with concerns about potential drug interactions or clinically significant medical conditions.1

View a brief video about screening prospective XYREM patients.

Prescribers will counsel each prospective XYREM patient on the serious risks, safe use, handling, and storage of XYREM.1

  • Prescribers will review the contents of the XYREM® REMS Program Patient Quick Start Guide with each patient.1
  • In addition, prescribers will encourage all patients to read the XYREM Medication Guide and to ask any questions they may have regarding treatment with XYREM.1

Prescriber counseling of prospective XYREM patients.

Before initiating treatment with XYREM, prescribers will counsel each patient on…1

  • The serious risks associated with XYREM.
  • Contraindications (alcohol, sedative hypnotics).
  • Risk of concomitant use of XYREM with alcohol, other CNS depressants, or other potentially interacting agents.
  • Preparation and dosing instructions for XYREM.
  • Risk of abuse and misuse associated with the use of XYREM.
  • Risk of operating hazardous machinery, including automobiles or airplanes, for the first 6 hours after taking a dose of XYREM.
  • Safe use, handling, and storage of XYREM.

View a brief video about counseling prospective XYREM patients.

Prescribers will evaluate each XYREM patient within the first 3 months of starting XYREM.1

  • It is thereafter recommended that patients be reevaluated every 3 months while on XYREM therapy.1

Prescriber evaluation of XYREM patients.

Prescribers will evaluate XYREM patients for issues including...1

  • Concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents.
  • Serious adverse events.
  • Signs of abuse and misuse such as an increase in dose or frequency of dosing; reports of lost, stolen, or spilled medication; and/or drug-seeking behavior.
  • Prescribers 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 Jazz Pharmaceuticals.1
  • To report suspected adverse reactions, contact Jazz Pharmaceuticals at:

Need help? Have questions? Get answers.

For further information, visit or call

XYREMREMS.com |
1-866-XYREM88®

(1-866-997-3688).

A Nurse Case Manager is available Monday – Friday, 7 AM – 8 PM, Central Time.
A pharmacist is available 24 hours a day, 7 days a week.