Getting XYWAV

XYWAV is available only through
the XYWAV and XYREM REMS

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What is the XYWAV and XYREM REMS program?

Because of the risk of central nervous system (CNS) depression, abuse, and misuse, all patients who are prescribed XYWAV must be enrolled in the XYWAV and XYREM REMS (Risk Evaluation and Mitigation Strategy) program. The REMS program supplies XYWAV through the Certified Pharmacy.

Before you or your child receives XYWAV, your doctor and pharmacist will make sure you understand how to take XYWAV safely and effectively.

More information about the REMS can be found at XYWAVXYREMREMS.com. If you have any questions, you can ask your doctor or call XYWAV and XYREM REMS specialists at 1-866-997-3688.

The XYWAV and XYREM REMS provides:

24/7 phone access to a pharmacist to answer any questions you have about XYWAV treatment.

Overnight delivery of your XYWAV prescription so you can get it quickly.

Delivery of your prescription to your door, a local overnight carrier hub, or another location, if approved by the Certified Pharmacy.

The steps to help you get started before getting your first shipment:

1
Your doctor will enroll you in the XYWAV and XYREM REMS (if you're not already enrolled), send your prescription to the Certified Pharmacy, and work with the pharmacy to initiate the insurance process.
2
Your JazzCares^® Nurse Case Manager will call you to help with enrollment in the XYWAV and XYREM REMS, answer questions about the prior authorization process, verify your insurance coverage, and discuss your eligibility for cost‑savings programs.
3
A pharmacist will call to counsel you on XYWAV safety information, answer any questions you may have about XYWAV, review your medical history, and arrange for the first shipment.
4
The Certified Pharmacy ships XYWAV to you overnight, along with a copy of the XYWAV and XYREM REMS Patient Quick Start Guide or the XYWAV and XYREM Brochure for Pediatric Patients and Their Caregivers.*
5
The Certified Pharmacy sends you reminders based on your preferences and arranges for the delivery of refills.

*This brochure only applies to children with narcolepsy and their caregivers.

If you are currently taking XYREM^® (sodium oxybate) oral solution, you are already enrolled in the XYWAV and XYREM REMS and will not need to be re-enrolled.

Watch these helpful videos

Learn about the steps you can take to get started on XYWAV

Watch the video to learn about enrolling in the REMS program

Enrolling in the Risk Evaluation and Mitigation Strategy (REMS)

Learn about the XYWAV and XYREM REMS, including how to enroll and how to schedule your first prescription through the Certified Pharmacy

IMPORTANT SAFETY INFORMATION

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.

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