FrequentlY Asked Questions

XYREM® REMS Program Overview

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.

Prescriber Enrollment

Yes. All Prescribers must enroll in the XYREM REMS Program before prescribing XYREM.1

To enroll in the XYREM REMS Program, prescribers must review the XYREM full Prescribing Information (PI) and XYREM REMS Program Prescriber Brochure, and complete and submit the one-time XYREM REMS Program Prescriber Enrollment Form.1

By signing the Prescriber Enrollment Form, the prescriber acknowledges understanding of important information about XYREM, including the approved indications and serious risks, and agrees to comply with program requirements to ensure safe use. Prescribers must submit the completed and signed Prescriber Enrollment Form to the Certified Pharmacy by either faxing to 1-866-470-1744 (toll free), scanning and emailing to XYREMPrescribers@express-scripts.com, or mailing to XYREM REMS Program, PO Box 66589, St. Louis, MO 63166-6589.1 Secure online enrollment is also available at XYREMREMS.com.

Prescribers should refer to the XYREM REMS Program Prescriber Brochure for details on enrollment requirements.1

For new prescribers, enrollment for each practice location is encouraged to ensure timely fulfillment of a patient’s prescription; this is best done by submitting a Prescriber Enrollment Form for each office location.

If your location, phone, or fax number changes, fill in the new information on the next XYREM REMS Program Prescription Form you submit to the Certified Pharmacy. Verification of all new information will be completed upon receipt. Prescribers do not need to send in a new Prescriber Enrollment Form to communicate change of address or contact information.

Changes in contact information should be added to the next XYREM REMS Program Prescription Form submitted to the Certified Pharmacy. Verification of all new information will be completed upon receipt. Prescribers do not need to send in a new Prescriber Enrollment Form to communicate change of address or contact information.

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.

Yes. Secure online enrollment for prescribers and patients is available at XYREMREMS.com. The XYREM REMS Program Prescriber Enrollment Form can also be scanned and submitted via email.

The XYREM REMS Program Prescription Form is not available electronically.

In addition to confirming receipt of all completed forms, the Certified Pharmacy will reach out to the designated office contact or prescriber to notify him or her if any form contains insufficient or incorrect information.1

For the XYREM REMS Program Prescriber Enrollment Form and XYREM REMS Program Patient Enrollment Form, the Certified Pharmacy can verbally obtain certain missing information (ie, demographic information) by contacting the prescriber office, and complete the enrollment process. Forms will be returned to the prescriber if checkboxes or signature/date fields are left blank. All forms will be returned to the prescriber if the Certified Pharmacy is unable to reach the prescriber via phone. In these cases, the prescriber will receive a fax notification including a copy of the submitted form, with instructions to complete and resubmit the form to the Certified Pharmacy.

Patient Enrollment

Yes. All patients must be enrolled in the XYREM REMS Program, using the XYREM REMS Program Patient Enrollment Form, prior to having their first XYREM prescription filled. The Certified Pharmacy will notify the prescriber when the patient is successfully enrolled and eligible to receive XYREM.1

To enroll a patient in the XYREM REMS Program, prescribers must screen each patient for certain medical conditions and concomitant medications and counsel each patient on the serious risks, safe use, handling, and storage of XYREM. Prescribers must review the contents of the XYREM REMS Program Patient Quick Start Guide with each patient and encourage all patients to read the XYREM Medication Guide and to ask any questions they may have regarding treatment with XYREM.1

After screening and counseling the patient, prescribers must complete the one-time XYREM REMS Program Patient Enrollment Form. Both the patient and the prescriber must sign and date this form to acknowledge that the patient has been counseled about the serious risks and safe use of XYREM and that he or she has asked any questions he or she had about XYREM. Prescribers must submit the completed and signed Patient Enrollment Form to the Certified Pharmacy by either faxing to 1-866-470-1744 (toll free) or mailing to XYREM REMS Program, PO Box 66589, St. Louis, MO 63166-6589.1 Secure online enrollment is also available at XYREMREMS.com.

Prescribers should refer to the XYREM REMS Program Prescriber Brochure for details on patient enrollment requirements.

The XYREM REMS Program is designed to ensure that all patients are educated on and understand the serious risks and safe use conditions of XYREM. The patient signs the XYREM REMS Program Patient Enrollment Form to acknowledge that the prescriber has counseled him or her on the serious risks and safe use of XYREM and that he or she has asked the prescriber any questions he or she may have had about XYREM.1

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.

Yes. Secure online enrollment for prescribers and patients is available at XYREMREMS.com. The XYREM REMS Program Prescriber Enrollment Form can also be scanned and submitted via email.

The XYREM REMS Program Prescription Form is not available electronically.

In addition to confirming receipt of all completed forms, the Certified Pharmacy will reach out to the designated office contact or prescriber to notify him or her if any form contains insufficient or incorrect information.1

For the XYREM REMS Program Prescriber Enrollment Form and XYREM REMS Program Patient Enrollment Form, the Certified Pharmacy can verbally obtain certain missing information (ie, demographic information) by contacting the prescriber office, and complete the enrollment process. Forms will be returned to the prescriber if checkboxes or signature/date fields are left blank. All forms will be returned to the prescriber if the Certified Pharmacy is unable to reach the prescriber via phone. In these cases, the prescriber will receive a fax notification including a copy of the submitted form, with instructions to complete and resubmit the form to the Certified Pharmacy.

Prescribing XYREM

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.

Yes. Secure online enrollment for prescribers and patients is available at XYREMREMS.com. The XYREM REMS Program Prescriber Enrollment Form can also be scanned and submitted via email.

The XYREM REMS Program Prescription Form is not available electronically.

In addition to confirming receipt of all completed forms, the Certified Pharmacy will reach out to the designated office contact or prescriber to notify him or her if any form contains insufficient or incorrect information.1

For the XYREM REMS Program Prescriber Enrollment Form and XYREM REMS Program Patient Enrollment Form, the Certified Pharmacy can verbally obtain certain missing information (ie, demographic information) by contacting the prescriber office, and complete the enrollment process. Forms will be returned to the prescriber if checkboxes or signature/date fields are left blank. All forms will be returned to the prescriber if the Certified Pharmacy is unable to reach the prescriber via phone. In these cases, the prescriber will receive a fax notification including a copy of the submitted form, with instructions to complete and resubmit the form to the Certified Pharmacy.

The Certified Pharmacy will alert you when your patients require refills and renewals. The Certified Pharmacy will send the prescriber a refill reminder fax along with a blank XYREM REMS Program Prescription Form that can be completed and submitted via fax or mail. Refills for current prescriptions may be called in to the Certified Pharmacy for the duration of the current valid Prescription Form. Each prescription is valid for 6 months from the date written (initial fill plus 5 refills per prescription).1

A prescriber office may convey refills and renewals by phone prior to a patient’s prescription expiring or running out of refills. To call in a refill or renewal, simply call the Certified Pharmacy at 1-866-XYREM88® (1-866-997-3688). The Certified Pharmacy will also send the prescriber a refill reminder fax along with a blank XYREM REMS Program Prescription Form that can be completed and submitted via fax or mail. Each Prescription Form is valid for 6 months from the date written (initial fill plus 5 refills per prescription).1

No. If you are submitting a refill or renewal to the Certified Pharmacy by fax or mail, it must be on the XYREM REMS Program Prescription Form.1

Patient Screening, Counseling, & Evaluation

Prior to initiating XYREM, the prescriber should screen each patient for 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; and history of depression or suicidality.1

The Certified Pharmacy will also specifically screen each patient for breathing disorders such as sleep apnea, asthma, or COPD; history of depression, suicidality, and drug or alcohol abuse; seizure disorders; hepatic impairment; and high blood pressure, heart problems, kidney problems, or salt-restricted diet.1

In addition, the Certified Pharmacy will screen each patient for potentially interacting agents, including 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]). Remember to include a list of all nonprescription and prescription concomitant medications, including dosing information, on or with the XYREM REMS Program Prescription Form. The Certified Pharmacy will contact the prescriber with concerns about potential drug interactions or clinically significant medical conditions.1

Prescribers must counsel each patient on the serious risks, safe use, handling, and storage of XYREM by reviewing the contents of the XYREM REMS Program Patient Quick Start Guide, and encourage all patients to read the XYREM Medication Guide and to ask any questions they may have regarding treatment with XYREM.1

Before initiating treatment with XYREM, the prescriber should counsel each patient on 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 use of XYREM; risk of operating hazardous machinery, including automobiles or airplanes, for the first 6 hours after taking a dose of XYREM; and the safe use, handling, and storage of XYREM.1

Prescribers should evaluate each patient within the first 3 months of starting XYREM. During the evaluation, prescribers should assess for concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents; serious adverse events; and 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.1

It is recommended that patients be re-evaluated every 3 months thereafter while on XYREM therapy.1

Role of the Certified Pharmacy

Following receipt of a patient’s prescription, the Certified Pharmacy will1:

  • Provide confirmation of each new XYREM REMS Program Prescription Form received
  • Contact the patient’s insurance provider to verify XYREM prescription benefits
  • Prior to the first shipment, contact the patient to:
    • Confirm whether he or she has received a copy of the XYREM REMS Program Patient Quick Start Guide; the Certified Pharmacy will send a copy of the XYREM REMS Program Patient Quick Start Guide to any patient not previously receiving one from his or her prescriber
    • Counsel the patient on expectations from XYREM therapy and how to prepare and take XYREM doses safely and effectively
    • Review important XYREM safety information and precautions for XYREM use
    • Review XYREM safe handling and storage procedures
    • Review the adverse events associated with XYREM use
    • Review the patient’s use of concomitant medications
      • You will be notified of any potential for drug interactions based on patient counseling.
    • Ask if the patient has any questions about XYREM and answer the questions and/or refer the patient back to the prescriber, as appropriate
  • Provide 24/7 toll-free telephone access to pharmacist support for prescribers, office staff, and patients by answering questions about safety, dosing, and patient care
  • Dispense and ship XYREM by overnight service to the patient or his or her authorized adult designee
  • Remind patients about monthly refills
  • Contact the prescriber if a prescription refill or renewal is required

Yes. The Certified Pharmacy provides 24/7 access to pharmacists.1

In addition, the Certified Pharmacy offers support for answering questions concerning the completion of required XYREM REMS Program Prescriber and Patient Enrollment Forms and the XYREM REMS Program Prescription Form.1

During counseling, the Certified Pharmacy will ask patients about their concomitant medications and conduct a drug utilization review for each patient. The Certified Pharmacy will also utilize First Databank’s electronic drug utilization review to see if any other prescription claims were processed for other medications that the patient may currently be taking. A pharmacist will continue to contact the prescriber if a possible serious drug interaction is uncovered, after reaching out to the patient to see if he or she is still taking that medication.1

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.