XYWAV ® calcium, magnesium, potassium, and sodium oxybates oral solution, 0. In addition, if short-term use of an opioid eg, post- or perioperative is required, interruption of treatment with XYWAV should be considered. After first initiating treatment and until certain that XYWAV does not affect them adversely eg, impair judgment, thinking, or motor skillscaution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes.
Abuse 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.
The rapid onset of sedation, coupled with the amnestic features of GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user eg, assault victim. Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.
Further information is available at www. XYWAV may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses of oxybate and with illicit use of GHB, life-threatening respiratory depression has been reported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult and pediatric patients.
A significant increase in the number of central apneas and clinically significant oxygen desaturation may occur in patients with obstructive sleep apnea treated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, Blandat och udda among patients with narcolepsy.
Two suicides and two attempted suicides occurred in adult clinical trials with oxybate same active moiety as XYWAV. One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate.
These events occurred in patients with and without previous histories of depressive disorders. The emergence of depression in patients treated with XYWAV requires careful and immediate evaluation. One patient experienced visual hallucinations and confusion after ingesting approximately 9 grams of XYWAV.
Other neuropsychiatric reactions reported with oxybate same active moiety as XYWAV in adult or pediatric clinical trials and in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety.
The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV should be carefully monitored. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate same active moiety as XYWAV and in postmarketing experience with sodium oxybate.
Episodes of sleepwalking should be fully evaluated and appropriate interventions considered. The overall adverse reaction profile of XYREM in the pediatric clinical trial was similar to that seen in the adult clinical trial program.
The most common adverse reaction leading to discontinuation was nausea 1. The most common adverse reaction leading to discontinuation was anxiety 3. In Study 1 and Study 2, the majority of adverse reactions leading to discontinuation began during the first few weeks of treatment.
In the pediatric clinical trial with XYREM same active moiety as XYWAV7 of patients reported adverse reactions that led to withdrawal from the study hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; affect lability; anger, anxiety, depression; and headache.
XYWAV is contraindicated in combination with alcohol or sedative hypnotics.