Patients Filling Their XYREM^® Prescriptions[1]

How is my patient's XYREM prescription filled?

All XYREM prescriptions are filled by a central, mail order pharmacy.

What does the central pharmacy do?

The physician sends the XYREM prescription directly to the pharmacy.
A team member from the pharmacy will contact the patient within 48 hours of receiving your prescription to review insurance information.
The pharmacy will confirm that the patient has received and/or understood this educational booklet. If the physician did not provide these materials to the patient, the pharmacy will review them with the patient before sending the patient's first shipment of XYREM.
The pharmacy will always confirm where and when the patient would like XYREM delivered and who will sign for the shipment. XYREM will be shipped via an overnight courier. When the courier arrives the patient or patient's designate must sign for the XYREM delivery.

What does the patient receive with the shipment of XYREM?

With each shipment the patient receives, there will be 1 or more bottles of XYREM, a liquid measuring device, 2 dosing cups with child-resistant caps and a printed medication guide.

Can a local pharmacy provide XYREM?

No, but in some cases, the patient may be able to have the courier deliver XYREM to a local pharmacy for later pickup.

What does it mean that XYREM is a controlled substance?

The active ingredient of XYREM is a form of GHB and has been a target for persons who abuse drugs. Because XYREM is a controlled substance, it is illegal for patients to sell or give XYREM to anyone else, or to use their XYREM for purposes other than it was prescribed. As with all controlled substances, failure to adhere to these rules may result in punishment under federal and state law by jail and fines.

Therefore, XYREM must be:

Used only by the patient.
Used only as directed by the physician.
Stored in a safe and secure place.

Refilling a XYREM prescription

When a patient has only a 7-day supply of XYREM remaining, the patient should call the Success Program^® to request the next shipment and be ready to tell the pharmacy team where they would like the prescription delivered and the name of the adult who will sign for the package.

The pharmacy team will arrange for the patient to receive a refill the next day via Federal Express delivery. Saturday delivery service is available at no additional charge. The pharmacy team can also arrange for the patient or a designated recipient to pick up the package at a Federal Express depot. If the patient chooses that shipping method, the pharmacy team will call to give the patient the Federal Express tracking number when the refill has been shipped. The patient or patient's designated recipient must have the tracking number to pick up the package.

While the pharmacy team will track the patient's XYREM use and call as the refill time approaches, the patient should not wait for the pharmacy's phone call. There should be no no interruption in the patient's therapy. When a prescription is running low, the patient should call the Success Program at 1-866-XYREM88^® (1-866-997-3688).

Obtaining a new prescription after the last refill

When the last refill of the patient's current XYREM prescription is shipped, the pharmacy team will enclose a card in the package to notify him or her. The pharmacy team will also make the refill process easy by sending a fax to you, the doctor, requesting that a new XYREM prescription be submitted to the pharmacy team. The pharmacy team will track the patient's XYREM use and call as the refill time approaches, but the patient should not wait for the pharmacy's phone call. The patient should call the pharmacy when they notice the prescription running low to request the next refill.

References:

^ The XYREM Success Program® for Patients, 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.

Patients Filling Their XYREM® Prescriptions[1]