A Patient’s Experience With XYWAV
Hear from Brooke, a patient with narcolepsy type 1 who is in her 30s and lives in Michigan. Brooke says she has experienced cataplexy for as long as she can remember, and she first noticed symptoms of excessive daytime sleepiness in third grade. Here, she shares her concerns about excessive sodium intake and why she talked to her doctor about XYWAV.
Real patient experience. Patient was compensated by Jazz Pharmaceuticals, Inc., for her participation. This is her experience in her own words. Each patient should be considered independently; other people’s experiences and treatment results may vary.
CV, cardiovascular.
Experts Discuss the Impact of XYWAV for Patients With Narcolepsy
Watch Dr Christopher Winter, a sleep specialist, moderate a discussion among a cardiologist, registered dietitian, and primary care/family practitioner as they share their perspectives on the clinical superiority of XYWAV* based on safety and what that could mean for patients with narcolepsy.
*Clinically superior | According to the US Food and Drug Administration (FDA), XYWAV is clinically superior to XYREM® (sodium oxybate) oral solution due to greater cardiovascular (CV) safety because the reduction in sodium at recommended doses will help a substantial portion of indicated patients reduce the risk of developing CV disease. Based on the determination of orphan drug exclusivity by the FDA Office of Orphan Products Development (OOPD) between XYWAV and XYREM. There are no head-to-head data for XYWAV and XYREM.
Participants were compensated for their time by Jazz Pharmaceuticals, Inc.
Participants were compensated for their time by Jazz Pharmaceuticals, Inc.
Reference: Data on File. (DOF-XYR-2023-030). Jazz Pharmaceuticals, Inc. May 2023.
XYWAV Is the Only Oxybate Indicated to Treat the
Narcolepsy Symptoms of Cataplexy and/or EDS Without an Excessive Sodium Burden1
Narcolepsy Symptoms of Cataplexy and/or EDS Without an Excessive Sodium Burden1
*XYWAV contains 131 mg of sodium at the maximum recommended 9-g nightly dose. XYREM® (sodium oxybate) oral solution and LUMRYZ™ (sodium oxybate) extended-release for oral suspension contain ~1640 mg of sodium at the equivalent dose.11
†Based on a determination of Orphan Drug Exclusivity by the FDA Office of Orphan Products Development (OOPD) between XYWAV and XYREM.1,12 There are no head-to-head data for XYWAV and XYREM.
†Based on a determination of Orphan Drug Exclusivity by the FDA Office of Orphan Products Development (OOPD) between XYWAV and XYREM.1,12 There are no head-to-head data for XYWAV and XYREM.
Important Safety Information
Pediatric Use
The safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial for narcolepsy. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and well-controlled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of XYWAV from healthy adult volunteers.
Safety and effectiveness of XYWAV in pediatric patients below the age of 7 years with narcolepsy have not been established.
Safety and effectiveness of XYWAV in pediatric patients below the age of 7 years with narcolepsy have not been established.
Geriatric Use
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Hepatic Impairment
The starting dose of XYWAV should be reduced in patients with liver impairment.
Dosage Modification in Patients with Hepatic Impairment: The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses.
Dosage Modification in Patients with Hepatic Impairment: The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses.
Dependence and Tolerance
There have been case reports of withdrawal, ranging from mild to severe, following discontinuation of illicit use of GHB at frequent repeated doses (18 g to 250 g per day) in excess of the recommended dosage range. Signs and symptoms of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in 3 to 14 days. In cases of severe withdrawal, hospitalization may be required.
In the clinical trial experience with XYREM in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In the XYWAV clinical trial in adult narcolepsy/cataplexy patients at recommended doses, one patient reported insomnia following abrupt discontinuation of XYWAV.
Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended XYWAV dosage regimen.
In the clinical trial experience with XYREM in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In the XYWAV clinical trial in adult narcolepsy/cataplexy patients at recommended doses, one patient reported insomnia following abrupt discontinuation of XYWAV.
Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended XYWAV dosage regimen.
References: 1. US Department of Health and Human Services, US Food and Drug Administration website. Clinical superiority findings. Accessed July 1, 2024. https://www.fda.gov/industry/designating-orphanproduct-drugs-and-biological-products/clinical-superiority-findings 2. Ohayon MM et al. Sleep. 2014;37(3):439-444. 3. Black J et al. Sleep Med. 2017;33:13-18. 4. Ben-Joseph RH et al. Sleep. 2023;46(10):zsad161. 5. Kaufmann C et al. Sleep. 2024;47(suppl 1):A368. 6. XYREM® (sodium oxybate). Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 7. Arnett DK et al. Circulation. 2019;140(11):e563-e595. 8. XYWAV® (calcium, magnesium, potassium, and sodium oxybates). Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 9. Whelton PK et al. Hypertension. 2018;71:e13-e115. 10. Ma Y et al. N Engl J Med. 2022;386(3):252-263. 11. Chen C et al. Clin Transl Sci. 2021;14(6):2278-2287. 12. Data on file (XYW-2023-030). Jazz Pharmaceuticals, Inc.
Important Safety Information
WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE.
- Central Nervous System Depression
XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses. Many patients who received XYWAV during clinical trials in narcolepsy were receiving CNS stimulants.