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Patient Success Program[1]
To support patients in obtaining and using XYREM®, Jazz Pharmaceuticals developed the XYREM Success Program® for Patients. This program includes educational materials about XYREM, and toll-free access to the XYREM central pharmacy where specially-trained staff are available to answer questions 24 hours a day/7 days a week.
1-866-XYREM88® (1-866-997-3688)
Before you receive XYREM, your doctor should determine that XYREM is the right medication for you. Then your doctor or other healthcare professionals will discuss the benefits, possible side effects, dosing, and preparation with you. It is very important to follow your doctor's instructions precisely and completely. Your doctor will enroll you in the XYREM Success Program, and you will receive information by mail from the XYREM central pharmacy.
A team member from the pharmacy will call you within 48 hours of receiving your prescription to review your insurance information. It is important that you take this call in order to receive your prescription. A pharmacist is also available to discuss any questions you may have.
The XYREM central pharmacy will send you information that you are required to read carefully. This includes an introductory letter, an informational brochure, a video on "How to Use XYREM", and a Patient Medication Guide. Remember, should you have any questions, please call 1-866-XYREM88 (1-866-997-3688).
XYREM is a medication that has been approved for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. Important information about XYREM includes the following:
- Twice nightly dosing: the first dose is taken at bedtime and the second dose 2½ – 4 hours later.
- Both doses should be taken while sitting up in bed.
- XYREM should not be taken with alcohol or other medications that cause drowsiness.
- Your XYREM prescription is filled and sent by a central, mail order pharmacy.
- The active ingredient of XYREM is a form of GHB and has been a target for persons who abuse drugs. Therefore your XYREM must be used only by you, only as directed by your physician, and stored in a safe, secure place, away from children and pets.
For more safety information, see the complete safety information and storage and safety tips at home.
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.
