Living with narcolepsy or idiopathic hypersomnia (IH) presents significant daily challenges. Excessive daytime sleepiness (EDS) and cataplexy, hallmarks of narcolepsy, and the overwhelming sleepiness of IH, can disrupt every aspect of life. For individuals diagnosed with these conditions, XYWAV® (calcium, magnesium, potassium, and sodium oxybates) offers a vital treatment option. However, accessing necessary medication can sometimes be a hurdle due to cost. This is where understanding resources like the Jazz Cares Patient Assistance Program becomes crucial.
XYWAV is prescribed to manage cataplexy and excessive daytime sleepiness in patients 7 years and older with narcolepsy, and for adults with idiopathic hypersomnia. It is important to understand both the benefits and the safety considerations associated with this medication, as well as the support systems available to help patients access it.
Understanding XYWAV: Indications and Important Safety Information
XYWAV is a central nervous system (CNS) depressant. While highly effective for its approved uses, it’s vital to be aware of its safety profile.
WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE.
These boxed warnings are critical and highlight the most serious risks associated with XYWAV:
-
Central Nervous System Depression: XYWAV can cause clinically significant respiratory depression and reduced alertness. It’s crucial to use it as prescribed and under the guidance of a healthcare professional. Many patients in clinical trials were also taking CNS stimulants, indicating the complexity of managing these conditions and the need for careful medication management.
-
Abuse and Misuse: The active ingredient in XYWAV is oxybate, also known as gamma-hydroxybutyrate (GHB). Illicit GHB is a substance with a history of abuse, leading to severe CNS reactions including seizures, respiratory depression, coma, and even death.
Image: XYWAV and XYREM REMS Program Logo, emphasizing the restricted distribution due to safety concerns.
Because of these significant risks, XYWAV is only available through a restricted program called the XYWAV and XYREM REMS (Risk Evaluation and Mitigation Strategy). This program is in place to ensure patient safety and appropriate use of the medication.
Who Should Not Take XYWAV? Contraindications
XYWAV is not suitable for everyone. It is contraindicated in the following situations:
- Combination with Sedative Hypnotics or Alcohol: Mixing XYWAV with these substances can dangerously amplify CNS depression, leading to severe and potentially life-threatening consequences.
- Succinic Semialdehyde Dehydrogenase Deficiency: This is a rare metabolic disorder that can interact negatively with XYWAV.
Important Warnings and Precautions
Beyond the boxed warnings, several other precautions are associated with XYWAV use:
Central Nervous System Depression – Further Details
Using XYWAV with other CNS depressants significantly increases the risk of serious side effects. These include:
- Opioid analgesics (pain medications)
- Benzodiazepines (anxiety and sleep medications)
- Sedating antidepressants or antipsychotics
- Sedating anti-epileptic drugs
- General anesthetics
- Muscle relaxants
- Illicit CNS depressants
If combining XYWAV with any of these is necessary, careful dose adjustments or discontinuation of one or more medications should be considered. If short-term opioid use is required, pausing XYWAV treatment may be necessary.
It’s crucial to understand how XYWAV affects you before engaging in activities requiring full mental alertness, such as driving or operating machinery. Avoid these activities for at least 6 hours after taking XYWAV and until you are confident it does not impair your abilities. Regularly discuss any CNS depression-related events with your healthcare provider.
Abuse and Misuse – A Closer Look
As mentioned, XYWAV is a Schedule III controlled substance because its active component, oxybate (GHB), is a Schedule I controlled substance. The potential for abuse is a serious concern. The rapid sedation and amnesia associated with GHB, especially when combined with alcohol, can be dangerous and has been linked to exploitation and harm.
Physicians will carefully evaluate patients for any history of drug abuse and closely monitor those considered at risk.
XYWAV and XYREM REMS – Ensuring Safe Access
The REMS program is essential for safe access to XYWAV. Key components of this program include:
- Certified Healthcare Providers: Only healthcare providers who are specially certified can prescribe XYWAV.
- Centralized Pharmacy Dispensing: XYWAV is dispensed exclusively through a certified central pharmacy.
- Patient Enrollment and Documentation: Patients must be enrolled in the XYWAV and XYREM REMS program and provide documentation of safe use to receive the medication.
For more detailed information about the REMS program, you can visit www.XYWAVXYREMREMS.com or call 1-866-997-3688.
Respiratory Depression and Sleep-Disordered Breathing Risks
XYWAV can affect respiratory drive, particularly in individuals with pre-existing respiratory issues. Overdoses of oxybate and illicit GHB use have been linked to life-threatening respiratory depression. Both adults and children may experience increased apnea and reduced oxygen levels while taking XYWAV. Patients with obstructive sleep apnea may experience a significant increase in central apneas and clinically significant oxygen desaturation.
Conditions like obesity, being male, postmenopausal women not on hormone replacement therapy, and narcolepsy itself increase the prevalence of sleep-related breathing disorders. These factors should be considered when prescribing and monitoring XYWAV.
Depression and Suicidality Monitoring
Clinical trials have shown instances of depression and depressed mood in patients taking XYWAV. While most cases did not require stopping treatment, some patients did discontinue XYWAV due to depression. Suicidal ideation and events have been reported in clinical trials with oxybate, both in adults and children, and in patients with and without prior history of depression.
Image: Monitoring Icon, representing the importance of ongoing patient monitoring for potential side effects.
It is crucial to monitor patients for the emergence or worsening of depressive symptoms and suicidal thoughts while on XYWAV. Immediate evaluation is necessary if depression arises.
Other Behavioral or Psychiatric Adverse Reactions
Beyond depression, other neuropsychiatric reactions have been reported, including confusion, anxiety, hallucinations, paranoia, psychosis, aggression, and agitation. These reactions require careful monitoring, and treatment adjustments may be needed.
Parasomnias – Sleepwalking and Related Events
Parasomnias, including sleepwalking, can occur with XYWAV use. Sleepwalking incidents, sometimes leading to injury, have been reported in clinical trials. Episodes of sleepwalking should be thoroughly evaluated, and appropriate interventions considered.
Common and Additional Adverse Reactions
The most common side effects (occurring in 5% or more of adult patients in clinical trials) include:
- Nausea
- Headache
- Dizziness
- Anxiety
- Insomnia
- Decreased appetite
- Hyperhidrosis (excessive sweating)
- Vomiting
- Diarrhea
- Dry mouth
- Parasomnia
- Somnolence
- Fatigue
- Tremor
In pediatric trials, common side effects also included enuresis (bedwetting) and weight decrease.
Less common but potentially relevant adverse reactions (occurring in 2% or more in oxybate studies) include pain, feeling drunk, pain in extremity, cataplexy, disturbance in attention, sleep paralysis, and disorientation.
Discontinuation due to adverse reactions occurred in some patients in clinical trials, with anxiety and nausea being among the more common reasons for stopping treatment. Most discontinuations happened within the first few weeks of treatment.
Drug Interactions to Be Aware Of
XYWAV should never be combined with alcohol or sedative hypnotics. As previously emphasized, other CNS depressants can significantly potentiate the depressant effects of XYWAV.
Concurrent use with divalproex sodium (an anti-epileptic and mood stabilizer) increases exposure to GHB. Therefore, a reduced starting dose of XYWAV is recommended when used with divalproex sodium, and close monitoring is advised.
Use During Pregnancy, Lactation, and in Specific Populations
If you are pregnant or breastfeeding, discuss XYWAV use with your healthcare provider. There is limited data on the safety of XYWAV during pregnancy. GHB passes into breast milk, so potential risks to a breastfeeding infant need to be considered along with the benefits of breastfeeding and the mother’s need for XYWAV.
Caution is advised when using XYWAV in geriatric patients and those with hepatic impairment. Lower starting doses are generally recommended in these populations.
Dependence, Tolerance, and Withdrawal
Withdrawal symptoms, ranging from mild to severe, have been reported after stopping illicit GHB use, especially at high doses. Symptoms can include anxiety, insomnia, tremor, sweating, hallucinations, and delirium. Hospitalization may be required in severe cases.
While tolerance to XYWAV has not been systematically studied in clinical trials, there are reports of tolerance developing with illicit GHB abuse at very high doses. Withdrawal symptoms have also been reported in some patients upon abrupt discontinuation of XYWAV in clinical trials, though less severe than those seen with illicit GHB withdrawal.
Accessing XYWAV and the Role of the Jazz Cares Patient Assistance Program
Understanding the complexities and safety information surrounding XYWAV is only part of the equation. For many, the cost of medication can be a significant barrier to access. This is where the Jazz Cares Patient Assistance Program offers crucial support.
The Jazz Cares Patient Assistance Program is designed to help eligible patients who are prescribed Jazz Pharmaceuticals medications, including XYWAV, gain access to their treatment. This program is particularly vital for individuals who may be uninsured, underinsured, or facing financial hardship that makes affording their medication challenging.
While specific eligibility criteria and program details are subject to change and are best obtained directly from the program, patient assistance programs generally consider factors such as:
- Income Level: Programs typically have income thresholds to qualify.
- Insurance Coverage: The level of insurance coverage (or lack thereof) is a key factor.
- Medical Need: Confirmation of the medical necessity of the prescribed medication.
- Residency: Often, patients must be residents of the country where the program is offered (in this context, likely the United States).
To learn more about the Jazz Cares Patient Assistance Program for XYWAV, and to determine if you or a loved one may be eligible, it is essential to:
- Visit the Official Jazz Pharmaceuticals Website: Look for a section dedicated to patient support or patient assistance programs. Search for “Jazz Cares” on the Jazz Pharmaceuticals website.
- Contact Jazz Pharmaceuticals Directly: Call their patient support line or customer service to inquire about the Jazz Cares program and XYWAV specifically. The REMS program website or materials may also provide contact information for patient support.
- Discuss with Your Healthcare Provider: Your doctor’s office may have information about patient assistance programs and can guide you on how to apply. They may also have resources or contacts to help with the application process.
- Explore Non-profit Patient Advocacy Groups: Organizations focused on narcolepsy and idiopathic hypersomnia may also offer resources and information about financial assistance programs for medications like XYWAV.
Image: Support Icon, representing the assistance and resources available to patients.
Navigating the healthcare system and managing the costs of chronic conditions like narcolepsy and idiopathic hypersomnia can be overwhelming. The Jazz Cares Patient Assistance Program serves as a critical lifeline, aiming to ensure that financial constraints do not prevent patients from accessing the medications they need. By understanding both the therapeutic benefits and safety considerations of XYWAV, and by exploring resources like Jazz Cares, patients and their healthcare teams can work together to improve health outcomes and quality of life.
Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional for diagnosis and treatment of medical conditions and before making any decisions related to your healthcare. Program details for the Jazz Cares Patient Assistance Program are subject to change; refer to official program information for the most up-to-date details and eligibility criteria. Please see full Prescribing Information, including BOXED Warning for complete details on XYWAV.
