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SMS Terms and Conditions

XYWAV® oral solution, 0.5 g/mL Terms & Conditions

How does the Program Work? Individuals can enroll in the SMS Program (the “Program”) via an online registration form. Individuals can select option to receive SMS text messages. All individuals enrolled in the program will receive an enrollment confirmation text message. You can expect to receive up to 10 texts each month during your participation in the Program.

Your Consent to These Terms and Conditions:

By signing up for the SMS Program, you are consenting to the terms and conditions set forth below, with respect to receiving autodialed text messages sent from or on behalf of Jazz Pharmaceuticals (“Jazz”). Providing your phone number and signing up is your electronic signature and provides electronic written consent. Consent is not a condition of purchase or use of any Jazz product. Jazz reserves the right to rescind, revoke or amend the Program without notice to you.

Use and Disclosure of Your Personal Information:

Data obtained from you in connection with the Program may include your phone number, related carrier information, and elements of pharmacy claim information. This information may be used to administer the Program and to provide you with Program benefits such as savings offers and Program updates and alerts sent directly to your mobile device. Please see our Privacy Statement for more general information on how we may collect, use and disclose personal information about you.

Text Messages Sent to You:

The Program is valid with most major US carriers, but not all cellular phone providers carry the necessary service to participate. Participating Carriers: The service is available on AT&T, Sprint, T-Mobile, Verizon Wireless, Boost, Cricket, MetroPCS, U.S. Cellular, Virgin Mobile, ACS Wireless, Appalachian Wireless, Bluegrass Cellular, Carolina West Wireless, Cellcom, C-Spire Wireless (formerly Cellsouth), Cellular One of East Central Illinois, Cincinnati Bell Wireless, Cross (dba Sprocket), Duet IP, Element Mobile, EpicTouch, GCI Communications, Golden State, Hawkeye (Chat Mobility), Hawkeye (NW Missouri Cellular), Illinois Valley Cellular, Immix (Keystone Wireless / PC Management), Inland Cellular, iWireless, Mobi PCS (Coral Wireless LLC), Mosaic, MTPCS / Cellular One (Cellone Nation), Nex-Tech Wireless, nTelos, Panhandle Telecommunications, Peoples Wireless, Pioneer, Plateau, Revol Wireless, Rina – Custer, Rina – All West, Rina – Cambridge Telecom Coop, Rina – Eagle Valley Comm, Rina – Farmers Mutual Telephone Co, Rina – Nucla Nutria Telephone Co, Rina – Silver Star, Rina – South Central Comm, Rina – Syringa, Rina – UBET, Rina – Manti, South Canaan / CellularOne of NEPA, Thumb Cellular, Union Wireless, United, Viaero Wireless, West Central Wireless, Leaco, Nemont/Sagebrush. T-Mobile is not liable for delayed or undelivered messages. The service is offered on an “as-is” basis and may not be available in all areas at all times and may not continue to work in the event of product, software, coverage or other changes made by your wireless carrier. Carriers are not responsible for delayed or undelivered messages. Check your phone capabilities for specific text messaging instructions. There is no fee charged to you for receiving Program messages that is payable to Jazz or anyone acting on its behalf; however, your carrier’s message and data rates may apply depending on your individual wireless pricing plan, in accordance with your wireless customer agreement. You are responsible for all applicable taxes. Consult your wireless service provider regarding its pricing plans.

Participant Opt-Out or Help: You may opt-out from participating in the Program at any time. Text STOP to 98637 or reply STOP to any message to opt-out. For help, text HELP to 98637 or reply HELP to any message or call Jazz Cares at 1-833-533-JAZZ (5299).

XYWAV™ (calcium, magnesium, potassium, and sodium oxybates) oral solution, 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate) is a prescription medicine used to treat the following symptoms in people 7 years of age or older with narcolepsy:

  • sudden onset of weak or paralyzed muscles (cataplexy)
  • excessive daytime sleepiness (EDS)

Important Safety Information

WARNING: Taking XYWAV with other central nervous system (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.

The active ingredient of XYWAV is a form of gamma hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death. Call your doctor right away if you or your child has any of these serious side effects.

Because of these risks, you have to go through the XYWAV and XYREM REMS Program to have your or your child’s prescription for XYWAV filled.

Do not take XYWAV if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drinks alcohol, or has a rare problem called succinic semialdehyde dehydrogenase deficiency.

 

Keep XYWAV in a safe place to prevent abuse and misuse. Selling or giving away XYWAV may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

 

Anyone who takes XYWAV should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYWAV. Those activities should not be done until you know how XYWAV affects you or your child.

 

XYWAV can cause serious side effects, including the following:

  • Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use XYWAV.
  • Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, or difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself or themselves. Call your doctor right away if you have or your child has symptoms of mental health problems or a change in weight or appetite.
  • Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child starts sleepwalking. Your doctor should check you or your child.

 

The most common side effects of XYWAV in adults include headache, nausea, dizziness, decreased appetite, parasomnia (a sleep disorder that can include abnormal dreams, abnormal rapid eye movement (REM) sleep, sleep paralysis, sleep talking, sleep terror, sleep-related eating disorder, sleep walking, and other abnormal sleep-related events), diarrhea, excessive sweating (hyperhidrosis), anxiety and vomiting.

 

The most common side effects of XYWAV in children include nausea, bedwetting, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking.

 

XYWAV can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of XYWAV.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

Please see full Prescribing Information, including BOXED Warning, and Medication Guide.

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