LEARN MORE
talk…
XYREM for...
cataplexy
and/or EDS...
narcolepsy.1
FDA-approved
treatment for
cataplexy and/or
EDS in narcolepsy
in patients 7 years
and older.1,2
INDICATIONS AND USAGE
XYREM® (sodium oxybate) oral solution, 0.5 g/mL is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Important Safety Information
- Central Nervous System Depression
XYREM is a Central Nervous System (CNS) depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with XYREM. Many patients who received XYREM during clinical trials in narcolepsy were receiving CNS stimulants.
- Abuse and Misuse
XYREM is the sodium salt of gamma hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.
Because of the risks of CNS depression and abuse and misuse, XYREM is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYREM REMS Program.
CONTRAINDICATIONS
XYREM is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency.
WARNINGS AND PRECAUTIONS
- CNS Depression: Use caution when considering the concurrent use with other CNS depressants. If concurrent use is required, consider dose reduction or discontinuation of one or more CNS depressants (including XYREM). Consider interrupting XYREM treatment if short-term opioid use is required. After first initiating treatment and until certain that XYREM does not affect them adversely, caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. Also caution patients against these hazardous activities for at least 6 hours after taking XYREM. Patients should be queried about CNS depression-related events upon initiation of XYREM therapy and periodically thereafter.
- Abuse and Misuse: XYREM is a Schedule III controlled substance. The rapid onset of sedation, coupled with the amnestic features of XYREM, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim).
- Respiratory Depression and Sleep-Disordered Breathing: XYREM may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses, life-threatening respiratory depression has been reported. Prescribers should be aware that increased central apneas and clinically relevant desaturation events have been observed with XYREM administration in adult and pediatric patients. Sleep-related breathing disorders tend to be more prevalent in obese patients and in postmenopausal women not on hormone replacement therapy as well as among patients with narcolepsy.
- Depression and Suicidality: In adult clinical trials in patients with narcolepsy (n=781), depression was reported by 7% of XYREM-treated patients, with four patients (<1%) discontinuing because of depression. In the pediatric clinical trial in patients with narcolepsy (n=104), one patient experienced suicidal ideation while taking XYREM. Monitor patients for emergent or increased depression and/or suicidality, which require careful and immediate evaluation.
- Other Behavioral or Psychiatric Adverse Reactions: Monitor patients for impaired motor/cognitive function or the emergence of or increase in anxiety and/or confusion. The emergence or increase in the occurrence of behavioral or psychiatric events in adult and pediatric patients taking XYREM should be carefully monitored.
- Parasomnias: Episodes of sleepwalking should be fully evaluated and appropriate interventions considered. Five instances of significant injury or potential injury were associated with sleepwalking during a clinical trial of XYREM in adult patients with narcolepsy. Parasomnias, including sleepwalking, also have been reported in the pediatric clinical trial and in postmarketing experience with XYREM.
- Patients Sensitive to High Sodium Intake: XYREM has a high salt content. In patients sensitive to salt intake (eg, those with heart failure, hypertension, or renal impairment), consider the amount of daily sodium intake in each dose of XYREM.
MOST COMMON ADVERSE REACTIONS
In three controlled adult clinical trials in patients with narcolepsy, the most common adverse reactions (incidence ≥5% and twice the rate of placebo) in XYREM-treated patients were nausea, dizziness, vomiting, somnolence, enuresis, and tremor. In the pediatric clinical trial in patients 7 years of age and older with narcolepsy, the most common adverse reactions (≥5%) were enuresis (18%), nausea (17%), headache (16%), vomiting (16%), weight decreased (12%), decreased appetite (8%), and dizziness (6%).
References: 1. XYREM® (sodium oxybate) [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals. 2. Abad VC. An evaluation of sodium oxybate as a treatment option for narcolepsy. Expert Opin Pharmacother. 2019;20(10):1189-1199.