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Storage & Safety Tips at Home[1]
Storage
- Always keep XYREM® in its original container.
- XYREM can be stored at room temperature.
- Like all medications, XYREM should be kept in a secure location out of the reach of children and pets. In case of accidental ingestion, call the poison center at 1-800-222-1222 or dial 911.
Disposal
- When you can no longer draw medication out of the bottle with the measuring device, it is time to throw the bottle away. Pour any unused XYREM down the drain. Scribble over the label with a marker before putting in the trash so someone else cannot use it for illegal purposes.
Refills
- Remember to reorder your XYREM when you have only a 7-day supply remaining. Call the pharmacy at 1-866-XYREM88® (1-866-997-3688) to request a refill.
Problems
- If your supply of XYREM is lost or stolen, please report the incident immediately to the local police and the pharmacy.
- Use only as directed. Remember that use of your XYREM by others is illegal.
- If you have questions, concerns, or need advice regarding XYREM, call your doctor or the pharmacy.
If you have any questions, 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.
