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WHY XYWAV FOR IH

FAQs

  • What is idiopathic hypersomnia (IH)?

    IH is a rare central sleep disorder. Idiopathic means the cause is unknown. Central means it is related to how the brain works.

    Some key symptoms of IH are feeling very sleepy during the day; experiencing sleep inertia (sleep drunkenness); and long, unrefreshing sleep. People living with IH still experience these symptoms despite sleeping a normal (or more than normal) amount each night.

  • What is XYWAV?

    XYWAV is the first and only FDA-approved treatment for idiopathic hypersomnia (IH). It is indicated for adults living with IH.

  • How is XYWAV thought to work?

    XYWAV is thought to work during sleep to help with the symptoms of idiopathic hypersomnia during the day. The exact way XYWAV works for the treatment of idiopathic hypersomnia is unknown.

  • How was the efficacy of XYWAV studied in people living with idiopathic hypersomnia (IH)?

    The efficacy of XYWAV was studied in 115 people aged 19-75 with IH. The XYWAV IH clinical trial was a double-blind, randomized withdrawal trial. That means all people in the clinical trial started treatment with XYWAV. They all adjusted XYWAV to a stable dose (the dose that worked best for them). Then they were randomly assigned to continue treatment with XYWAV or switched to placebo for 2 weeks. Neither the clinical investigators nor the people in the trial knew who got XYWAV or who got placebo.

  • What are the possible side effects of XYWAV?

    The most common side effects in adult patients treated with XYWAV in the idiopathic hypersomnia clinical trial included nausea, headache, dizziness, anxiety, insomnia, decreased appetite, excessive sweating (hyperhidrosis), vomiting, diarrhea, dry mouth, 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, sleepwalking, and other abnormal sleep-related events), sleepiness (somnolence), fatigue, and tremor. In patients who remained on treatment, side effects tended to occur early and diminish over time.

    These are not all the possible side effects of XYWAV. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. 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.

  • When could I start to see a change in symptoms?

    After starting XYWAV, it may take some time for you and your doctor to determine the right dose, and to see symptoms improve. Your doctor will decide on a starting dose. If needed, he or she may adjust your dose or dosing routine.

  • What does XYWAV contain?

    XYWAV oral solution contains oxybate, a CNS depressant. XYWAV contains a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. A 9 gram/night dose contains 687 mg of calcium, 182 mg of magnesium, 642 mg of potassium, and 131 mg of sodium. XYWAV also contains an artificial sweetener called sucralose. XYWAV does not contain any ingredient made from a gluten-containing grain (wheat, barley, or rye).

  • How do I take XYWAV?

    If your doctor prescribes you nightly XYWAV, he or she will give you detailed instructions on how to take your prescribed dose(s). You will also receive additional materials to ensure that you understand how to prepare and take your nightly XYWAV dose(s).

  • What if I have trouble waking up for my second dose of XYWAV?

    It’s easy to understand why you might worry about taking your second dose. You may want to set an alarm clock to help you wake up for your second dose of XYWAV. If you miss your second dose, skip that dose. Do not take XYWAV again until the next night. Never take two doses of XYWAV at one time.

  • How much does XYWAV cost?

    Jazz Pharmaceuticals is committed to making sure that people who are prescribed XYWAV can get it affordably.

  • What support is available if my doctor prescribes XYWAV?

    Jazz Pharmaceuticals, the leader in sleep medicine, is committed to helping you get therapy support and assistance throughout your treatment journey based on your personal needs every step of the way.

    • Nurse and pharmacy support—Your JazzCares® Nurse Case Manager will be with you from the very beginning in your treatment journey, and a pharmacist is available 24/7 to answer questions about your prescription
    • Access and affordability—The Certified Pharmacy will assist you with navigating the insurance process and understanding your insurance coverage to help get your treatment started
    • Personalized resources—At different points along the way, you will receive relevant tools and resources to help as you start and continue your therapy, including:
      • myWAV, the 24/7 digital tool for personalized support and motivation
      • A Starter Kit to help you get started on your path to your first shipment of XYWAV
      • A Welcome Kit to help manage your XYWAV treatment
      • Prescription refill reminders
      • Information and support resources for caregivers and loved ones
  • Why can’t I get XYWAV at my local pharmacy?

    Because of the risk of CNS depression, abuse, and misuse, XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS. You must be enrolled in this program to receive XYWAV.

    In addition, the Certified Pharmacy is the only pharmacy in the United States that is permitted to fill your XYWAV prescription and send it directly to you.

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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)
  • idiopathic hypersomnia (IH) in adults.

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 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. XYWAV can cause sleepwalking, which can cause injuries. Call your doctor if this occurs.

 

The most common side effects of XYWAV in adults include nausea, headache, dizziness, anxiety, insomnia, decreased appetite, excessive sweating (hyperhidrosis), vomiting, diarrhea, dry mouth, 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, sleepwalking, and other abnormal sleep-related events), somnolence, fatigue, and tremor.

The most common side effects of XYREM (which also contains oxybate like 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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