Quick Start Guide[1]

The procedure for writing and dispensing XYREM^® prescriptions is outlined below. The central pharmacy with the XYREM Success Program^® is available at 1-866-XYREM88^® (1-866-997-3688) to support you, your staff and your patients, and to answer any questions you might have.

Before prescribing XYREM

Prescribing XYREM requires entry into a physician registry
To do so, complete the Physician Registration Form and return it to the pharmacy.

Prescribing Requirements

Confirm that each patient for whom you prescribe XYREM has been educated with respect to XYREM preparation, dosing and scheduling, and whether you have given the patient a copy of the patient education materials.
Since optimal patient response often requires dose titration, you should evaluate your patients frequently during the early stages of treatment.
The recommended starting dose is 4.5 grams nightly taken in equally divided doses of 2.25 grams. Each patient's dose may be titrated within the effective dose range of 6–9 grams/night.
Once stable dosage is established, patients should be evaluated and prescriptions rewritten every 3 months.

Prescription Form

Fax the completed XYREM Patient Enrollment Form and Prescription Form and all subsequent prescriptions to the pharmacy at 1-866-470-1744.
Patients are entered in a registry maintained at the pharmacy.

Central Pharmacy's Role

Following receipt of your prescription, the pharmacy will:

Send confirmation of each prescription received to your office.
Request additional information or clarification if necessary.
Contact the patient's insurance provider to verify benefits and eligibility.
Contact the patient to:
- Confirm that you have educated the patient regarding the XYREM Patient Success Program, and given the patient a copy of the education materials. If not, the pharmacy will educate the patient.
- Confirm XYREM delivery details.
- Review preparation, administration and storage instructions.
Dispense and ship XYREM by overnight courier to the patient or his/her designee.
Send XYREM Patient Success Program materials to the patient with the first XYREM shipment, if you have not already provided them.
Maintain a patient and prescriber registry.

References:

^ The XYREM Success Program® for Physicians, Jazz Pharmaceuticals, Inc.

Important Safety Information

1. XYREM^® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug — which means that it has a moderate dependence liability. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.

2. It is very important to keep XYREM out of reach of children and pets.

3. XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.

BOXED WARNING:

!Warning

Central Nervous System Depressant with Abuse Potential. Should not be used with alcohol or other CNS depressants. Sodium oxybate is a form of GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression, and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants.

Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (e.g., dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).

XYREM is available through the XYREM Success Program^®, using a centralized pharmacy 1-866-XYREM88^® (1-866-997-3688). The Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The XYREM Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.