Traveling Tips for Patients[1]

Before a Trip

When packing for a trip, the patient should be sure to take enough XYREM^® for the length of time he or she will be away.
The patient may want to check with the airlines for current FAA restrictions pertaining to carryon prescription products and liquids.
Patients should always travel with XYREM in its original container, with the pharmacy label on it.
Patients should take only the number of bottles of XYREM needed for their stay away from home. Patients should be sure that any XYREM bottles left behind are in a secure place before they leave home.
Patients should not pack XYREM in a suitcase that will be checked baggage. XYREM should be kept in a secure location when it is not in the patient's possession.
Patients should remember to take the dispensing device and the dosing cups with child-resistant caps when traveling. In an unfamiliar environment, it is especially important that the patient's second nightly dose of XYREM is not left in an unsecured place or within the reach or children or pets.

During a Trip

When patients pack to return home, they should remember to pack their XYREM.
If the patient forgets XYREM while traveling within the United States or needs more due to an extended stay, he or she can call the pharmacy at 1-866-XYREM88^®.
If traveling internationally, be aware that XYREM may be subject to different regulations in other countries. Patients should always travel with XYREM in its original container, with the pharmacy label on it.

Problems

If the supply of XYREM is lost or stolen while traveling, the patient should report the incident immediately to the local police and the pharmacy.

If you have questions, concerns, or need advice regarding XYREM while traveling, please call 1-866-XYREM88 (1-866-997-3688).

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.